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 |
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Results information
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Results version number |
v1 |
This version publication date |
05 Jan 2019
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First version publication date |
05 Jan 2019
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Other versions |
v2 |
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 |
Sascha Tillmanns, Morphosys AG, 0049 89 89927 26520, Sascha.tillmanns@morphosys.com
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Scientific contact |
Sascha Tillmanns, Morphosys AG, 0049 89 89927 26520, Sascha.tillmanns@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 |
Interim
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Date of interim/final analysis |
31 Aug 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Aug 2015
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Global end of trial reached? |
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 Harmonization (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 will include 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 |
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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 |
Belgium: 2
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Country: Number of subjects enrolled |
Germany: 7
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Country: Number of subjects enrolled |
Spain: 12
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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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Country: Number of subjects enrolled |
United States: 20
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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 |
1. Pts were male or female ≥ 18 years of age. 2. Pts with a histologically confirmed diagnosis of DLBCL, FL, MCL or other indolent NHL (e.g., MZL/MALT). 3. Progression after at least 1 prior rituximab-containing regimen. 4. At least one site of measurable disease on MRI or CT. | ||||||||||||||||||||
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Period 1
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Period 1 title |
MOR00208 (overall 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 |
MOR00208 12 mg/kg. The study population consisted of adult patients with relapsed or refractory B-cell NHL who had received at least 1 completed cycle of combination therapy with rituximab + chemotherapy or at least 4 weekly administrations of rituximab as monotherapy. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
MOR00208
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Investigational medicinal product code |
MOR00208
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Other name |
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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.
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Baseline characteristics reporting groups
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Reporting group title |
MOR00208
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Reporting group description |
MOR00208 12 mg/kg. The study population consisted of adult patients with relapsed or refractory B-cell NHL who had received at least 1 completed cycle of combination therapy with rituximab + chemotherapy or at least 4 weekly administrations of rituximab as monotherapy. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
MOR00208
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Reporting group description |
MOR00208 12 mg/kg. The study population consisted of adult patients with relapsed or refractory B-cell NHL who had received at least 1 completed cycle of combination therapy with rituximab + chemotherapy or at least 4 weekly administrations of rituximab as monotherapy. | ||
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End point title |
Overall response rate [1] | ||||||
End point description |
Overall response rate (CR+PR; complete and partial remission), 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 |
Total study period
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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 clinical trial was analysed descriptively. |
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| No statistical analyses for this end point | |||||||
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End point title |
Stable disease | ||||||
End point description |
Number of patients on stable disase
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End point type |
Secondary
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End point timeframe |
Total study period
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| No statistical analyses for this end point | |||||||
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End point title |
Time to progression | ||||||||
End point description |
Assessed by the investigator rate of progression of the total population (all subsets) until date of first tumor progression.
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End point type |
Secondary
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End point timeframe |
Total study period
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| No statistical analyses for this end point | |||||||||
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End point title |
Progression free survival | ||||||||
End point description |
Progression free survival was defined as the time from cycle 1 day 1 until date of first tumor progression or date of death from any cause.
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End point type |
Secondary
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End point timeframe |
Total study period
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
To ensure patient safety, every SAE/AE, regardless of suspected causality, occurring after the patient had provided informed consent and untill 30 days after the patient had stopped study participation was to be recorded.
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Adverse event reporting additional description |
Adverse events were coded according to MedDRA (version 14) system organ class (SOC) and preferred term. Incidence of all adverse events was summarized by SOC, preferred term, relationship to treatment, severity and seriousness. Adverse events were summarized overall and by each NHL subtype.
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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 |
14.0
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Reporting groups
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Reporting group title |
MOR00208
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Reporting group description |
MOR00208 patients with at least one infusion of drug | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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07 Jan 2013 |
Clinical deficiency/information request from FDA dated 05 October 2012, a clinical deficiency/information request from FDA dated 11 October 2012 and 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 |
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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 release of the original protocol, none of which constituted a change in the conduct or scientific value of the study |
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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. |
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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 and 5. Minor editorial changes for clarification of contant and removal of inconsistencies. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
