Clinical Trial Results:
A Phase IIa, Open-label, Multicenter Study of Single-agent MOR00208, an Fc-Optimized Anti-CD19 Antibody, in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma
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Summary
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EudraCT number |
2012-002659-41 |
Trial protocol |
BE IT HU ES DE PL |
Global end of trial date |
06 Apr 2022
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Results information
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Results version number |
v2(current) |
This version publication date |
21 Apr 2023
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First version publication date |
05 Jan 2019
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Other versions |
v1 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
MOR208C201
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01685008 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Morphosys AG
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Sponsor organisation address |
Semmelweisstrasse 7, Planegg, Germany, 82152
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Public contact |
Medical Information, Morphosys AG, +1 844 667-1992, medinfo@morphosys.com
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Scientific contact |
Medical Information, Morphosys AG, +1 844 667-1992, medinfo@morphosys.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
15 Jun 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
06 Apr 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Apr 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study was to assess the antitumor activity of single-agent MOR00208 in adult patients with relapsed or refractory NHL who have received at least 1 prior therapy containing rituximab as one of the treatments.
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Protection of trial subjects |
This trial was designed, conducted and reported in accordance with the International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice (GCP), applicable local regulations (including European Directive 2001/20/EC), and following the ethical principles laid down in the Declaration of Helsinki. Specific ICH adopted and other relevant international guidelines and recommendations were taken into account as far as meaningfully possible. Safety monitoring for all patients enrolled in the study included laboratory safety assessments (haematology, blood chemistry, urinalysis, coagulation, and anti-MOR00208 antibodies) and clinical evaluations (physical examinations, vital signs, 12-lead ECG) as detailed in the Schedule of Assessments.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Apr 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 12
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Country: Number of subjects enrolled |
United States: 20
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Country: Number of subjects enrolled |
Belgium: 2
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Country: Number of subjects enrolled |
Germany: 7
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Country: Number of subjects enrolled |
Hungary: 16
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Country: Number of subjects enrolled |
Italy: 19
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Country: Number of subjects enrolled |
Poland: 16
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Worldwide total number of subjects |
92
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EEA total number of subjects |
72
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
43
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From 65 to 84 years |
46
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85 years and over |
3
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Recruitment
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Recruitment details |
This was a Phase IIa open-label, multicenter safety and efficacy study of MOR00208, that was planned to enroll approximately 40 to 120 adult patients with refractory or relapsed NHL who have received at least 1 prior therapy containing rituximab. | ||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Patients were male or female ≥ 18 years of age, with a histologically confirmed diagnosis of FL, other indolent NHL (e.g., MZL/MALT), DLBCL, or MCL. Patients must have had progression of their NHL after at least 1 prior rituximab-containing regimen, and had at least 1 site of measurable disease on an MRI or CT scan. | ||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Screening Period
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||
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Arms
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Arm title
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MOR00208 | ||||||||||||||||||||||||||
Arm description |
A total of 113 patients were screened; of these, 21 were screening failures and did not receive treatment with MOR00208. 92 patients completed screening and received at least one dose of study drug. | ||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||
Investigational medicinal product name |
MOR00208
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Investigational medicinal product code |
MOR00208
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Other name |
MOR208, XmAb5574, tafasitamab
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Pharmaceutical forms |
Solution for infusion in administration system
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Routes of administration |
Intravenous use
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Dosage and administration details |
MOR00208 drug product is a lyophilisate supplied in single-use 20 mL glass vials. Each vial contains 200 mg of MOR00208 for reconstitution with 5 mL water for injection. Intravenous infusions were administered at the study site, beginning on Cycle 1 Day 1.
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Period 2
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Period 2 title |
Main Study Treatment (Cycles 1-2)
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Is this the baseline period? |
No | ||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||
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Arms
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Arm title
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MOR00208 | ||||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||
Investigational medicinal product name |
MOR00208
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Investigational medicinal product code |
MOR00208
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Other name |
MOR208, XmAb5574, tafasitamab
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Pharmaceutical forms |
Solution for infusion in administration system
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Routes of administration |
Intravenous use
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Dosage and administration details |
MOR00208 drug product is a lyophilisate supplied in single-use 20 mL glass vials. Each vial contains 200 mg of MOR00208 for reconstitution with 5 mL water for injection. Intravenous infusions were administered at the study site, beginning on Cycle 1 Day 1.
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Period 3
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Period 3 title |
Post Cycle 2 (C3 and Maintenance)
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Is this the baseline period? |
No | ||||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||||
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Arms
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Arm title
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MOR00208 | ||||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||
Investigational medicinal product name |
MOR00208
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Investigational medicinal product code |
MOR00208
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Other name |
MOR208, XmAb5574, tafasitamab
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Pharmaceutical forms |
Solution for infusion in administration system
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Routes of administration |
Intravenous use
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Dosage and administration details |
MOR00208 drug product is a lyophilisate supplied in single-use 20 mL glass vials. Each vial contains 200 mg of MOR00208 for reconstitution with 5 mL water for injection. Intravenous infusions were administered at the study site, beginning on Cycle 1 Day 1.
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Baseline characteristics reporting groups
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Reporting group title |
MOR00208
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Reporting group description |
A total of 113 patients were screened; of these, 21 were screening failures and did not receive treatment with MOR00208. 92 patients completed screening and received at least one dose of study drug. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
MOR00208
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Reporting group description |
A total of 113 patients were screened; of these, 21 were screening failures and did not receive treatment with MOR00208. 92 patients completed screening and received at least one dose of study drug. | ||
Reporting group title |
MOR00208
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Reporting group description |
- | ||
Reporting group title |
MOR00208
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Reporting group description |
- | ||
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End point title |
Overall Response Rate (ORR) [1] | ||||||||||
End point description |
Proportion of Patients with Complete Remission (CR) or Partial Remission (PR), assessed as per the 2007 International Working Group (IWG) response criteria
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End point type |
Primary
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End point timeframe |
From first dose until Follow-up Visit 12, up to 4.5 years
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The primary endpoint for this open-label study was a count of responders; no statistical analyses or comparisons are applicable. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Stable Disease (SD) Rate | ||||||
End point description |
Proportion of Patients with Stable Disease
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End point type |
Secondary
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End point timeframe |
From first dose until Follow-up Visit 12, up to 4.5 years
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| No statistical analyses for this end point | |||||||
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End point title |
Duration of Response (DoR) | ||||||||
End point description |
Time from first response (CR or PR) to first documentation of relapse/progression, for patients who had any response during the study.
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End point type |
Secondary
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End point timeframe |
From first dose until Follow-up Visit 12, up to 4.5 years
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| Notes [2] - The upper CI was not reached; "1000000" entered as numerical value required. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to Progression (TTP) | ||||||||
End point description |
Time from first dosing until documentation of progression or death due to lymphoma
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End point type |
Secondary
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End point timeframe |
From first dose until Follow-up Visit 12, up to 4.5 years
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| Notes [3] - Patients with documented progression of disease. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Progression-free Survival (PFS) | ||||||||
End point description |
Time from first dosing until progression or death due to any case
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End point type |
Secondary
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End point timeframe |
From first dose until Follow-up Visit 12, up to 4.5 years
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| Notes [4] - Patients with documented progression or death from any cause. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Incidence and Severity of Adverse Events (AEs) | ||||||||||||
End point description |
Number of patients with treatment-emergent AEs rated Mild, Moderate, and Severe
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End point type |
Secondary
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End point timeframe |
From first dose until 30 days after last dose of MOR00208, up to 8.5 years
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments | ||||||||||||||||
End point description |
Number of patients with at least one positive (+ve) post-Baseline sample containing positive anti-MOR00208 antibodies; Baseline (pre-dose) sample has to be tested negative (-ve)
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End point type |
Secondary
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End point timeframe |
From first dose until Follow-up Visit 3, up to 7 months
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of MOR00208 | ||||||||
End point description |
The highest concentration of MOR00208 measured in serum
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End point type |
Secondary
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End point timeframe |
Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)
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| Notes [5] - PK parameters were calculated as data permitted for the PK Population. |
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| No statistical analyses for this end point | |||||||||
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End point title |
PK Parameter: Time to Maximum Serum Concentration Observed (Tmax) of MOR00208 | ||||||||
End point description |
The time to highest concentration of MOR00208 measured in serum
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End point type |
Secondary
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End point timeframe |
Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)
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| Notes [6] - PK parameters were calculated as data permitted for the PK Population. |
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| No statistical analyses for this end point | |||||||||
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End point title |
PK Parameter: Apparent Trough Serum Concentration Before Dosing (Clast) of MOR00208 | ||||||||
End point description |
The last quantifiable concentration from the first dose of MOR00208
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End point type |
Secondary
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End point timeframe |
Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)
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| Notes [7] - PK parameters were calculated as data permitted for the PK Population. |
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| No statistical analyses for this end point | |||||||||
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End point title |
PK Parameter: Area Under the Concentration Curve From Dose Time Zero to the Time the Last Quantifiable Concentration is Observed (AUC[0-t]) of MOR00208 | ||||||||
End point description |
Area under the concentration curve. The time curve from time zero (0) to the time that the last concentration above the lower limit of quantification (LLQ) is observed.
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End point type |
Secondary
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End point timeframe |
Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)
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| Notes [8] - PK parameters were calculated as data permitted for the PK Population. |
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| No statistical analyses for this end point | |||||||||
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End point title |
PK Parameter: Apparent Terminal Rate Constant (λz) of MOR00208 | ||||||||
End point description |
Apparent terminal rate constant calculated from the regression analysis (slope) from the log-transformed measured concentrations on the terminal phase of the time-point concentration curve
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End point type |
Secondary
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End point timeframe |
Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
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| Notes [9] - PK parameters were calculated as data permitted for the PK Population. |
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| No statistical analyses for this end point | |||||||||
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End point title |
PK Parameter: Apparent Terminal Half-life (t[1/2]) of MOR00208 | ||||||||
End point description |
Apparent terminal half-life calculated from ln(2)/λz
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End point type |
Secondary
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End point timeframe |
Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
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| Notes [10] - PK parameters were calculated as permitted for the PK Population. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Absolute Change From Baseline in Measurements of B-cell Populations | ||||||||||||||||||||||||||||
End point description |
Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: B-cell populations
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End point type |
Secondary
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End point timeframe |
Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
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| Notes [11] - Pharmacodynamic samples were collected at timepoints through the study where possible. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percent Change From Baseline in Measurements of B-cell Populations | ||||||||||||||||||||||||||||
End point description |
Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: B-cell populations
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End point type |
Secondary
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End point timeframe |
Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
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| Notes [12] - Pharmacodynamic samples were collected at timepoints through the study where possible. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Absolute Change From Baseline in Measurements of T-cell Populations | ||||||||||||||||||||||||||||
End point description |
Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: T-cell populations
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End point type |
Secondary
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End point timeframe |
Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
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| Notes [13] - Pharmacodynamic samples were collected at timepoints through the study where possible. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percent Change From Baseline in Measurements of T-cell Populations | ||||||||||||||||||||||||||||
End point description |
Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: T-cell populations
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End point type |
Secondary
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End point timeframe |
Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
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| Notes [14] - Pharmacodynamic samples were collected at timepoints through the study where possible. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Absolute Change From Baseline in Measurements of NK Cell Populations | ||||||||||||||||||||||||||||
End point description |
Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: NK cell populations
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End point type |
Secondary
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End point timeframe |
Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
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| Notes [15] - Pharmacodynamic samples were collected at timepoints through the study where possible. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percent Change From Baseline in Measurements of NK Cell Populations | ||||||||||||||||||||||||||||
End point description |
Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: NK cell populations
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End point type |
Secondary
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End point timeframe |
Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)
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| Notes [16] - Pharmacodynamic samples were collected at timepoints through the study where possible. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
|||||||||||||
End point title |
Evaluation of AEs Stratified by FcγRIIa Polymorphism | ||||||||||||
End point description |
Incidence of AEs as stratified by FcγRIIa polymorphism subgroups
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From first dose until 30 days after last dose of MOR00208, up to 8.5 years
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Evaluation of AEs Stratified by FcγRIIIa Polymorphism | ||||||||||||
End point description |
Incidence of AEs as stratified by FcγRIIIa polymorphism subgroups
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From first dose until 30 days after last dose of MOR00208, up to 8.5 years
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Evaluation of ORR Stratified by FcγRIIa Polymorphism | ||||||||||||
End point description |
The analysis of the primary endpoint (ORR) will additionally be stratified by FcγRIIa polymorphism subgroups
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From first dose until Follow-up Visit 12, up to 4.5 years
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Evaluation of ORR Stratified by FcγRIIIa Polymorphism | ||||||||||||
End point description |
The analysis of the primary endpoint (ORR) will additionally be stratified by FcγRIIIa polymorphism subgroups
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From first dose until Follow-up Visit 12, up to 4.5 years
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||
End point title |
PK Parameter: Area Under the Concentration Curve From Dose Time Zero to Infinity (AUC[0-inf]) of MOR00208 | ||||||||
End point description |
Area under the concentration curve. The time curve from time zero (0) to infinity (inf), where infinity is computed from AUC0-t + [Ct/λZ)]. Ct is calculated from the concentration at the last sampling time at which the sample is above LLQ.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
|
||||||||
|
|||||||||
| Notes [17] - The parameter could not be accurately estimated for the PK Population. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
PK Parameter: Total Body Clearance (CL) of MOR00208 | ||||||||
End point description |
Total body clearance calculated for single or multiple doses: dose(s)/AUC(0-inf)
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
|
||||||||
|
|||||||||
| Notes [18] - The parameter could not be accurately estimated for the PK Population. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
PK Parameter: Apparent Volume of Distribution (Vz) of MOR00208 | ||||||||
End point description |
Apparent volume of distribution during the terminal phase, calculated from dose/(AUC(0-inf)*λz)
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])
|
||||||||
|
|||||||||
| Notes [19] - The parameter could not be accurately estimated for the PK Population. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||
End point title |
Evaluation of AEs Stratified by Baseline CD19 Expression on Malignant Lymphoma Cells | ||||||
End point description |
Incidence of AEs as stratified by presence of CD19 on malignant lymphoma cells detected by tumor biopsy/aspirate during Screening
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
From first dose until 30 days after last dose of MOR00208, up to 8.5 years
|
||||||
|
|||||||
| Notes [20] - CD19 expression could not be measured in sufficient cases for such an analysis to be meaningful. |
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||
End point title |
Evaluation of ORR Stratified by Baseline CD19 Expression on Malignant Lymphoma Cells | ||||||
End point description |
The analysis of the primary endpoint (ORR) will additionally be stratified by presence of CD19 on malignant lymphoma cells detected by tumor biopsy/aspirate during Screening
|
||||||
End point type |
Secondary
|
||||||
End point timeframe |
From first dose until Follow-up Visit 12, up to 4.5 years
|
||||||
|
|||||||
| Notes [21] - CD19 expression could not be measured in sufficient cases for such an analysis to be meaningful. |
|||||||
| No statistical analyses for this end point | |||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
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Timeframe for reporting adverse events |
Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years
|
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Adverse event reporting additional description |
AEs were detected when volunteered by the patient during or between study visits or through physical examination, laboratory tests, or other assessments. All SAEs are reported, including non-treatment-emergent events. For non-serious AEs, only treatment-emergent events are reported.
|
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.0
|
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Reporting groups
|
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Reporting group title |
MOR00208
|
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Reporting group description |
All patients who received at least one dose of study drug. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
07 Jan 2013 |
1. A clinical deficiency/information request from FDA dated 05 October 2012.
2. A clinical deficiency/information request from FDA dated 11 October 2012.
3. Minor inconsistencies identified and organizational changes made since release of the original protocol, none of which constitute a change in the conduct or scientific value of the study. |
||
02 Oct 2013 |
1. Organizational issues that came up during the initiation of the first study sites.
2. Minor inconsistencies identified and organizational changes made since the release of the original protocol, none of which constituted a change in the conduct or scientific value of the study. |
||
15 Apr 2014 |
1. New recommendations for the screening of hepatitis B for anti-CD20 antibodies were published.
2. Minor inconsistencies identified and organizational changes were made since the release of the previous amendment, none of which constitute a change in the conduct or scientific value of the study. |
||
19 Sep 2017 |
1. Change of address of sponsor and CRO.
2. Addition of optional prolongation of maintenance treatment for patients beyond Follow-up Visit 12 until progression.
3. Change of sponsor signatories and change of key personnel at sponsor and CRO.
4. Change of data collection as a result of this amendment.
5. Minor editorial changes for clarification of content and removal of inconsistencies. |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
