Trial Outcomes & Findings for Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial (NCT NCT00911183)

Last Updated: 2025-08-29

Results Overview

Complete remission \[CR\] is defined according to Cheson criteria. CR requires the following: 1. Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities. 2. All lymph nodes and nodal masses must have regressed to normal size. Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter before treatment must have decreased to ≤1 cm in their greatest transverse diameter after treatment, or by more than 75% in the sum of the products of the greatest diameters (SPD). 3. The spleen, if considered to be enlarged before therapy on the basis of a CT scan, must have regressed in size and must not be palpable on physical examination. 4. If the bone marrow was involved by lymphoma before treatment, the infiltrate must be cleared on repeat bone marrow aspirate and biopsy of the same site.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

67 participants

Primary outcome timeframe

6 months after randomization

Results posted on

2025-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (R-COP Regimen) Patients receive rituximab IV, cyclophosphamide IV, and vincristine sulfate IV on day 1. Patients also receive oral prednisone on days 1-5 and filgrastim subcutaneously (SC) on days 8-14 or pegfilgrastim SC on day 2. Treatment repeats every 21 days for at least 3 courses. filgrastim: Given subcutaneously pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV prednisone: Given orally vincristine sulfate: Given IV	Arm II (R-COPY Regimen) Patients receive rituximab, cyclophosphamide, vincristine sulfate, prednisone, and filgrastim or pegfilgrastim as in arm I. Patients also receive liposome-encapsulated doxorubicin citrate IV on day 1. Treatment repeats every 21 days for at least 3 courses. filgrastim: Given subcutaneously pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV liposome-encapsulated doxorubicin citrate: Given IV prednisone: Given orally vincristine sulfate: Given IV
Overall Study STARTED	47	20
Overall Study COMPLETED	47	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (R-COP Regimen) n=47 Participants Patients receive rituximab IV, cyclophosphamide IV, and vincristine sulfate IV on day 1. Patients also receive oral prednisone on days 1-5 and filgrastim subcutaneously (SC) on days 8-14 or pegfilgrastim SC on day 2. Treatment repeats every 21 days for at least 3 courses. filgrastim: Given subcutaneously pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV prednisone: Given orally vincristine sulfate: Given IV	Arm II (R-COPY Regimen) n=20 Participants Patients receive rituximab, cyclophosphamide, vincristine sulfate, prednisone, and filgrastim or pegfilgrastim as in arm I. Patients also receive liposome-encapsulated doxorubicin citrate IV on day 1. Treatment repeats every 21 days for at least 3 courses. filgrastim: Given subcutaneously pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV liposome-encapsulated doxorubicin citrate: Given IV prednisone: Given orally vincristine sulfate: Given IV	Total n=67 Participants Total of all reporting groups
Age, Continuous	82.8 years STANDARD_DEVIATION 4.2 • n=47 Participants	81.1 years STANDARD_DEVIATION 4.1 • n=20 Participants	82.4 years STANDARD_DEVIATION 4.2 • n=67 Participants
Sex: Female, Male Female	24 Participants n=47 Participants	10 Participants n=20 Participants	34 Participants n=67 Participants
Sex: Female, Male Male	23 Participants n=47 Participants	10 Participants n=20 Participants	33 Participants n=67 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	47 participants n=47 Participants	20 participants n=20 Participants	67 participants n=67 Participants

PRIMARY outcome

Timeframe: 6 months after randomization

Outcome measures

Outcome measures
Measure	Arm I (R-COP Regimen) n=47 Participants Patients receive rituximab IV, cyclophosphamide IV, and vincristine sulfate IV on day 1. Patients also receive oral prednisone on days 1-5 and filgrastim subcutaneously (SC) on days 8-14 or pegfilgrastim SC on day 2. Treatment repeats every 21 days for at least 3 courses. filgrastim: Given subcutaneously pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV prednisone: Given orally vincristine sulfate: Given IV	Arm II (R-COPY Regimen) n=20 Participants Patients receive rituximab, cyclophosphamide, vincristine sulfate, prednisone, and filgrastim or pegfilgrastim as in arm I. Patients also receive liposome-encapsulated doxorubicin citrate IV on day 1. Treatment repeats every 21 days for at least 3 courses. filgrastim: Given subcutaneously pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV liposome-encapsulated doxorubicin citrate: Given IV prednisone: Given orally vincristine sulfate: Given IV
Number of Participants in Complete Remission 6 Months After Randomization	14 Participants	9 Participants

PRIMARY outcome

Timeframe: 6 months after randomization

Severe toxicity, defined as febrile neutropenia or toxic death. Febrile neutropenia is defined in the International CTC toxicity scale as "fever of unknown origin without clinically or microbiologically documented infection: neutrophils \< 1.0 x 109/l and fever ≥ 38.5° C. Toxic death is defined as any death which occur during treatment (from day 1 of the first cycle of chemotherapy up to day 30 of the last cycle) and is not related to lymphoma.

Outcome measures

Outcome measures
Measure	Arm I (R-COP Regimen) n=47 Participants Patients receive rituximab IV, cyclophosphamide IV, and vincristine sulfate IV on day 1. Patients also receive oral prednisone on days 1-5 and filgrastim subcutaneously (SC) on days 8-14 or pegfilgrastim SC on day 2. Treatment repeats every 21 days for at least 3 courses. filgrastim: Given subcutaneously pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV prednisone: Given orally vincristine sulfate: Given IV	Arm II (R-COPY Regimen) n=20 Participants Patients receive rituximab, cyclophosphamide, vincristine sulfate, prednisone, and filgrastim or pegfilgrastim as in arm I. Patients also receive liposome-encapsulated doxorubicin citrate IV on day 1. Treatment repeats every 21 days for at least 3 courses. filgrastim: Given subcutaneously pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV liposome-encapsulated doxorubicin citrate: Given IV prednisone: Given orally vincristine sulfate: Given IV
Number of Participants With Severe Toxicity	10 Participants	8 Participants

SECONDARY outcome

Timeframe: from randomization, up to 5 years

OS is defined as the delay between the date of randomization and the date of death

Outcome measures

Outcome measures
Measure	Arm I (R-COP Regimen) n=47 Participants Patients receive rituximab IV, cyclophosphamide IV, and vincristine sulfate IV on day 1. Patients also receive oral prednisone on days 1-5 and filgrastim subcutaneously (SC) on days 8-14 or pegfilgrastim SC on day 2. Treatment repeats every 21 days for at least 3 courses. filgrastim: Given subcutaneously pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV prednisone: Given orally vincristine sulfate: Given IV	Arm II (R-COPY Regimen) n=20 Participants Patients receive rituximab, cyclophosphamide, vincristine sulfate, prednisone, and filgrastim or pegfilgrastim as in arm I. Patients also receive liposome-encapsulated doxorubicin citrate IV on day 1. Treatment repeats every 21 days for at least 3 courses. filgrastim: Given subcutaneously pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV liposome-encapsulated doxorubicin citrate: Given IV prednisone: Given orally vincristine sulfate: Given IV
Overall Survival Time	20.1 months Interval 10.4 to 25.4	25.4 months Interval 12.2 to the upper limit of 95%CI could not be estimated due to insufficient number of participants with events

SECONDARY outcome

Timeframe: from randomization, up to 5 years

Delay between the date of randomization and the date of progression or death. Progression is defined according to the Cheson criteria.

Outcome measures

Outcome measures
Measure	Arm I (R-COP Regimen) n=47 Participants Patients receive rituximab IV, cyclophosphamide IV, and vincristine sulfate IV on day 1. Patients also receive oral prednisone on days 1-5 and filgrastim subcutaneously (SC) on days 8-14 or pegfilgrastim SC on day 2. Treatment repeats every 21 days for at least 3 courses. filgrastim: Given subcutaneously pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV prednisone: Given orally vincristine sulfate: Given IV	Arm II (R-COPY Regimen) n=20 Participants Patients receive rituximab, cyclophosphamide, vincristine sulfate, prednisone, and filgrastim or pegfilgrastim as in arm I. Patients also receive liposome-encapsulated doxorubicin citrate IV on day 1. Treatment repeats every 21 days for at least 3 courses. filgrastim: Given subcutaneously pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV liposome-encapsulated doxorubicin citrate: Given IV prednisone: Given orally vincristine sulfate: Given IV
Progression-free Survival Time	10.4 months Interval 5.4 to 25.9	18.0 months Interval 5.2 to he upper limit of 95%CI could not be estimated due to insufficient number of participants with events

Adverse Events

Arm I (R-COP Regimen)

Serious events: 46 serious events

Other events: 0 other events

Deaths: 27 deaths

Arm II (R-COPY Regimen)

Serious events: 20 serious events

Other events: 0 other events

Deaths: 12 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Pr Pierre Soubeyran

Institut Bergonié

Phone: 33(0)556333333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm I (R-COP Regimen) n=47 participants at risk Patients receive rituximab IV, cyclophosphamide IV, and vincristine sulfate IV on day 1. Patients also receive oral prednisone on days 1-5 and filgrastim subcutaneously (SC) on days 8-14 or pegfilgrastim SC on day 2. Treatment repeats every 21 days for at least 3 courses. filgrastim: Given subcutaneously pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV prednisone: Given orally vincristine sulfate: Given IV	Arm II (R-COPY Regimen) n=20 participants at risk Patients receive rituximab, cyclophosphamide, vincristine sulfate, prednisone, and filgrastim or pegfilgrastim as in arm I. Patients also receive liposome-encapsulated doxorubicin citrate IV on day 1. Treatment repeats every 21 days for at least 3 courses. filgrastim: Given subcutaneously pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV liposome-encapsulated doxorubicin citrate: Given IV prednisone: Given orally vincristine sulfate: Given IV
Blood and lymphatic system disorders Febrile aplasia	8.5% 4/47 • Number of events 4 • up to 5 years after randomization Adverse events (other than serious) were not collected	5.0% 1/20 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected
Blood and lymphatic system disorders Febrile neutropenia	6.4% 3/47 • Number of events 4 • up to 5 years after randomization Adverse events (other than serious) were not collected	10.0% 2/20 • Number of events 2 • up to 5 years after randomization Adverse events (other than serious) were not collected
Blood and lymphatic system disorders Pancytopenia	0.00% 0/47 • up to 5 years after randomization Adverse events (other than serious) were not collected	5.0% 1/20 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected
Cardiac disorders Arrythmia	0.00% 0/47 • up to 5 years after randomization Adverse events (other than serious) were not collected	5.0% 1/20 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected
Cardiac disorders Aurticular fibrillation	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Cardiac disorders cardiogenic shock	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Cardiac disorders myocaridal infarct	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Gastrointestinal disorders Abdominal pain	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Gastrointestinal disorders dysphagia	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Gastrointestinal disorders Ileus paralytic	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Gastrointestinal disorders other	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	5.0% 1/20 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected
Gastrointestinal disorders sigmoiditis	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
General disorders asthenia	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
General disorders death	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	10.0% 2/20 • Number of events 2 • up to 5 years after randomization Adverse events (other than serious) were not collected
General disorders fever	0.00% 0/47 • up to 5 years after randomization Adverse events (other than serious) were not collected	5.0% 1/20 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected
General disorders general physical health deterioration	4.3% 2/47 • Number of events 3 • up to 5 years after randomization Adverse events (other than serious) were not collected	15.0% 3/20 • Number of events 3 • up to 5 years after randomization Adverse events (other than serious) were not collected
General disorders malaise	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
General disorders sudden death	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Hepatobiliary disorders biliary obstruction	0.00% 0/47 • up to 5 years after randomization Adverse events (other than serious) were not collected	5.0% 1/20 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected
Hepatobiliary disorders cholestasis	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Infections and infestations Basterial pyelonephritis	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Infections and infestations Clotridium difficile colitis	4.3% 2/47 • Number of events 2 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Infections and infestations Enterobacter septicemia	0.00% 0/47 • up to 5 years after randomization Adverse events (other than serious) were not collected	10.0% 2/20 • Number of events 2 • up to 5 years after randomization Adverse events (other than serious) were not collected
Infections and infestations other	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Infections and infestations pseudomonas	0.00% 0/47 • up to 5 years after randomization Adverse events (other than serious) were not collected	5.0% 1/20 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected
Infections and infestations sepsis	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Infections and infestations Septic shock	10.6% 5/47 • Number of events 5 • up to 5 years after randomization Adverse events (other than serious) were not collected	5.0% 1/20 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected
Infections and infestations virosis	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Injury, poisoning and procedural complications fall	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Injury, poisoning and procedural complications femure fracture	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Metabolism and nutrition disorders dehydratation	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Metabolism and nutrition disorders Hyperuricemia	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Musculoskeletal and connective tissue disorders other	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphomateous meningitis	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Nervous system disorders Accident cerebrovascular	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Nervous system disorders convulsion	0.00% 0/47 • up to 5 years after randomization Adverse events (other than serious) were not collected	5.0% 1/20 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected
Nervous system disorders other	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Renal and urinary disorders Hematuria	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Respiratory, thoracic and mediastinal disorders Acute respiratory insufficiency	0.00% 0/47 • up to 5 years after randomization Adverse events (other than serious) were not collected	5.0% 1/20 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected
Respiratory, thoracic and mediastinal disorders Asthmatoid bronchitis	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Respiratory, thoracic and mediastinal disorders Distress respiratory	8.5% 4/47 • Number of events 4 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Respiratory, thoracic and mediastinal disorders Dyspnea	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Respiratory, thoracic and mediastinal disorders Interstitial pneumonitis	0.00% 0/47 • up to 5 years after randomization Adverse events (other than serious) were not collected	5.0% 1/20 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected
Respiratory, thoracic and mediastinal disorders Other	2.1% 1/47 • Number of events 2 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Respiratory, thoracic and mediastinal disorders Pneumonitis allergic	0.00% 0/47 • up to 5 years after randomization Adverse events (other than serious) were not collected	5.0% 1/20 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.1% 1/47 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected	0.00% 0/20 • up to 5 years after randomization Adverse events (other than serious) were not collected
Vascular disorders Venous thrombosis	0.00% 0/47 • up to 5 years after randomization Adverse events (other than serious) were not collected	5.0% 1/20 • Number of events 1 • up to 5 years after randomization Adverse events (other than serious) were not collected