Trial Outcomes & Findings for MabThera (Rituximab) in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma (NCT NCT02486952)
NCT ID: NCT02486952
Last Updated: 2016-02-22
Results Overview
EFS was calculated as the time from randomization to the date of first reported event. Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause without progression.
Recruitment status
COMPLETED
Target enrollment
154 participants
Primary outcome timeframe
Up to 41 months
Results posted on
2016-02-22
Participant Flow
Participant milestones
| Measure |
Diffuse Large B-Cell Lymphoma
Participants, who were not treated previously for diffuse large B cell lymphoma (DLBCL), and received rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
|
|---|---|
|
Overall Study
STARTED
|
154
|
|
Overall Study
Started Induction Therapy
|
151
|
|
Overall Study
COMPLETED
|
104
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
Diffuse Large B-Cell Lymphoma
Participants, who were not treated previously for diffuse large B cell lymphoma (DLBCL), and received rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
|
|---|---|
|
Overall Study
Not Started Induction Therapy
|
3
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
15
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Lost to Follow-up
|
26
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
MabThera (Rituximab) in Combination With CHOP (or CHOP-like) Chemotherapy in Patients With Aggressive B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Diffuse Large B-Cell Lymphoma
n=151 Participants
Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 41 monthsPopulation: Full analysis population.
EFS was calculated as the time from randomization to the date of first reported event. Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause without progression.
Outcome measures
| Measure |
Diffuse Large B-Cell Lymphoma
n=151 Participants
Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
|
|---|---|
|
Probability of Event Free Survival (EFS)
|
0.695 probability of EFS
Interval 0.607 to 0.796
|
SECONDARY outcome
Timeframe: Up to 41 monthsPopulation: Full analysis population.
Percentage of participants with survival was calculated 41 months after the first dose of study treatment.
Outcome measures
| Measure |
Diffuse Large B-Cell Lymphoma
n=151 Participants
Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
|
|---|---|
|
Percentage of Participants Who Were Alive
|
74.4 percentage of participants
|
Adverse Events
Diffuse Large B-Cell Lymphoma
Serious events: 25 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Diffuse Large B-Cell Lymphoma
n=151 participants at risk
Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
|
|---|---|
|
Infections and infestations
Herpes zoster
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Infections and infestations
Peritonitis
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Infections and infestations
Pneumonia
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.3%
2/151 • 41 Months
Full analysis population.
|
|
Blood and lymphatic system disorders
Haematotoxicity
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Cardiac disorders
Arrhythmia
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Cardiac disorders
Cardiac disorder
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Cardiac disorders
Cardiomyopathy
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
General disorders
Death
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
General disorders
Disease progression
|
7.3%
11/151 • 41 Months
Full analysis population.
|
|
General disorders
Disease recurrence
|
2.0%
3/151 • 41 Months
Full analysis population.
|
|
General disorders
Drug resistance
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
General disorders
Sudden death
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Investigations
Ejection fraction decreased
|
0.66%
1/151 • 41 Months
Full analysis population.
|
Other adverse events
| Measure |
Diffuse Large B-Cell Lymphoma
n=151 participants at risk
Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician's discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
2/151 • 41 Months
Full analysis population.
|
|
Nervous system disorders
Headache
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Eye disorders
Eye swelling
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Cardiac disorders
Arrhythmia
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
5/151 • 41 Months
Full analysis population.
|
|
Gastrointestinal disorders
Proctalgia
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
2/151 • 41 Months
Full analysis population.
|
|
General disorders
Chills
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
General disorders
Fatigue
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
General disorders
Pyrexia
|
0.66%
1/151 • 41 Months
Full analysis population.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.3%
2/151 • 41 Months
Full analysis population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER