Clinical Trial Results:
A randomized, double-blind, multi-center, multi-national Phase III trial to compare efficacy and safety of BI 695500 plus chemotherapy versus rituximab plus chemotherapy in patients with untreated follicular non-Hodgkin’s lymphoma.
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Summary
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EudraCT number |
2011-002908-33 |
Trial protocol |
GB BE CZ IT SK |
Global end of trial date |
19 Oct 2012
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Jul 2018
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First version publication date |
08 Jul 2018
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Other versions |
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Summary report(s) |
Statement |
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 |
1301.2
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Boehringer Ingelheim
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Sponsor organisation address |
Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
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Public contact |
QRPE Processes and Systems Coordination, Clinical Trial
Information Disclosure, Boehringer Ingelheim, +1 8002430127, clintriage.rdg@boehringer-ingelheim.com
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Scientific contact |
QRPE Processes and Systems Coordination, Clinical Trial
Information Disclosure, Boehringer Ingelheim, +1 8002430127, clintriage.rdg@boehringer-ingelheim.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 |
19 Oct 2012
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 Oct 2012
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Oct 2012
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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 trial is to compare the efficacy (best overall response rate after completion of induction therapy) of BI 695500 plus chemotherapy versus rituximab plus chemotherapy in patients with untreated follicular lymphoma
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Protection of trial subjects |
No patient entered the study, therefore no results data available. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Oct 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Netherlands: 99999
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Country: Number of subjects enrolled |
Slovakia: 99999
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Worldwide total number of subjects |
199998
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EEA total number of subjects |
199998
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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) |
99999
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From 65 to 84 years |
99999
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85 years and over |
0
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Recruitment
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Recruitment details |
99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial | |||||||||
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Pre-assignment
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Screening details |
All subjects had to be screened for eligibility to participate in the trial. Subjects had to attend specialist sites which would then ensure that they (the subjects) met all inclusion/exclusion criteria. Subjects were not to be randomised to trial treatment if any one of the specific entry criteria were violated. | |||||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
Blinding implementation details |
As this is a double-blind trial, patients, investigators and all blinded trial personnel should remain blinded with regard to the randomized treatment assignments until after the final database lock.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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BI 695500 | |||||||||
Arm description |
BI 695500 (intravenous infusion) plus cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone or its equivalent glucocorticoid (CHOP), cyclophosphamide, vincristine and prednisone/prednisolone or its equivalent glucocorticoid (CVP) or bendamustine chemotherapy BI 695500: - 375 mg/m2 every 3 weeks for six cycles, for those patients receiving CHOP or CVP. - 375 mg/m2 every 4 weeks for six cycles, for those patients receiving bendamustine. - 375 mg/m2 every 8 weeks (12 infusions during the 2 years maintenance) | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
BI 695500
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
BI 695500 plus cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone or its equivalent glucocorticoid (CHOP), cyclophosphamide, vincristine and
prednisone/prednisolone or its equivalent glucocorticoid (CVP) or bendamustine chemotherapy BI 695500:
- 375 mg/m2 every 3 weeks for six cycles, for those patients receiving CHOP or CVP.
- 375 mg/m2 every 4 weeks for six cycles, for those patients receiving bendamustine.
- 375 mg/m2 every 8 weeks (12 infusions during the 2 years maintenance)
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Arm title
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Rituximab | |||||||||
Arm description |
Rituximab (Rituxan®) plus CHOP, CVP or bendamustine chemotherapy Rituximab: - 375 mg/m2 every 3 weeks for six cycles, for those patients receiving CHOP or CVP. - 375 mg/m2 every 4 weeks for six cycles, for those patients receiving bendamustine. - 375 mg/m2 every 8 weeks (12 infusions during the 2 years maintenance) | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Rituximab (Rituxan®
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Rituximab (Rituxan®) plus CHOP, CVP or bendamustine chemotherapy
Rituximab:
- 375 mg/m2 every 3 weeks for six cycles, for those patients receiving CHOP or CVP.
- 375 mg/m2 every 4 weeks for six cycles, for those patients receiving bendamustine.
- 375 mg/m2 every 8 weeks (12 infusions during the 2 years maintenance)
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
This is a Phase III, randomized, double-blind, parallel arm, active comparator trial. No patient entered the study, therefore no results data available. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial. | |||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
BI 695500
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Reporting group description |
BI 695500 (intravenous infusion) plus cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone or its equivalent glucocorticoid (CHOP), cyclophosphamide, vincristine and prednisone/prednisolone or its equivalent glucocorticoid (CVP) or bendamustine chemotherapy BI 695500: - 375 mg/m2 every 3 weeks for six cycles, for those patients receiving CHOP or CVP. - 375 mg/m2 every 4 weeks for six cycles, for those patients receiving bendamustine. - 375 mg/m2 every 8 weeks (12 infusions during the 2 years maintenance) | ||
Reporting group title |
Rituximab
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Reporting group description |
Rituximab (Rituxan®) plus CHOP, CVP or bendamustine chemotherapy Rituximab: - 375 mg/m2 every 3 weeks for six cycles, for those patients receiving CHOP or CVP. - 375 mg/m2 every 4 weeks for six cycles, for those patients receiving bendamustine. - 375 mg/m2 every 8 weeks (12 infusions during the 2 years maintenance) | ||
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End point title |
Objective response (OR) (complete response [CR] + partial response [PR]) at the completion of induction therapy, as defined by the modified International Working Group (IWG) criteria 2007, using Independent Radiology Assessment. [1] | |||||||||
End point description |
Objective response (OR) (complete response [CR] + partial response [PR]) at the completion of induction therapy, as defined by the modified International Working Group (IWG) criteria 2007, using Independent Radiology Assessment is presented.
99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
The primary analysis set will be the full analysis set (FAS) according to the intention-to-treat principle. The FAS consists of all randomized patients who received at least one dose of trial drug and had a baseline tumor assessment
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End point type |
Primary
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End point timeframe |
up to 24 weeks of induction immunochemotherapy.
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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: No subjects were enrolled in the trial hence results are not available |
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| Notes [2] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value [3] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Time to treatment failure | ||||||||||||
End point description |
Time to treatment failure is defined as the time from randomization until treatment failure including discontinuation of treatment for any reason (e.g., disease progression/relapse, treatment toxicity, patient preference, initiation of new anti-lymphoma treatment or death). Per protocol planned end of induction/maintenance treatment is not regarded as treatment failure. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled
in the trial.
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End point type |
Secondary
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End point timeframe |
up to 24 weeks of induction immunochemotherapy
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| Notes [4] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value [5] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value |
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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 |
Progression-free survival (PFS) will be assessed based on the investigator assessment of response.Progression-free survival is defined as the time from randomization until disease progression/relapse or death by any cause, whichever occurs first. Disease progression/relapse is assessed according to the modified IWG response criteria for malignant lymphoma 2007.
99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
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End point type |
Secondary
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End point timeframe |
up to 24 weeks of induction immunochemotherapy
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| Notes [6] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value [7] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Overall survival | ||||||||||||
End point description |
Overall survival is defined as the time from randomization until death as a result of any cause. 99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled
in the trial.
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End point type |
Secondary
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End point timeframe |
time from randomization until death as a result of any cause; collected up to database lock date
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| Notes [8] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value [9] - No patient entered the study, therefore no results data available. 99999 is "Not applicable" value |
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
All Adverse events occurring during the course of the clinical trial (which begins with signing of informed consent and ends with the end of the Residual Effect Period [REP]); up to 2 years
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Adverse event reporting additional description |
No patient entered the study, therefore no results data available.
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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 |
0
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No subjects were enrolled in the trial hence results are not available |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
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. | |||
| Discontinued by Boehringer Ingelheim during preparation of the trial. No patient entered the study, therefore no results data are available | |||
