Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial

NCT ID: NCT00911183

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-02
• Study Completion Date: 2015-01-01

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, prednisone, and liposome-encapsulated doxorubicin citrate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether rituximab and combination chemotherapy are more effective when given together with or without liposome-encapsulated doxorubicin citrate in treating older patients with diffuse large B-cell non-Hodgkin lymphoma.

PURPOSE: This randomized phase II trial is studying the side effects of giving rituximab together with cyclophosphamide, vincristine sulfate, and prednisone with or without liposome-encapsulated doxorubicin citrate and to see how well it works in treating older patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin lymphoma.

Detailed Description

OBJECTIVES:

Primary

• To assess the therapeutic efficacy of rituximab, cyclophosphamide, vincristine sulfate, and prednisone with vs without liposome-encapsulated doxorubicin citrate, in terms of complete remission rate at 6 months, in vulnerable or frail elderly patients with stage II, III, or IV diffuse large B-cell non-Hodgkin lymphoma.
• To assess the safety of these regimens in these patients.

Secondary

• To evaluate the progression-free survival, event-free survival, and overall survival rates at 6 and 24 months in patients treated with these regimens.
• To evaluate the overall response rate at 6 and 24 months in patients treated with these regimens.
• To evaluate the duration of complete remission in patients treated with these regimens.
• To evaluate the acute side effects (according to the International CTC scale) of these regimens in these patients.
• To evaluate the geriatric condition and quality of life of patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

• 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.
• 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.

After 3 courses of R-COP or R-COPY, patients undergo evaluation. Patients with disease progression or a response of < 25% are removed from the study. Patients with a response of ≥ 25% receive 3 more courses of R-COP or R-COPY, followed by rituximab IV alone on day 1 of courses 7 and 8 in the absence of disease progression or unacceptable toxicity.

After the completion of chemotherapy, some patients may undergo radiotherapy.

Patients complete quality of life and geriatric assessment questionnaires at baseline and periodically during study treatment.

After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years.

Conditions

Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

filgrastim

Intervention Type: BIOLOGICAL

Given subcutaneously

pegfilgrastim

Intervention Type: BIOLOGICAL

Given subcutaneously

rituximab

Intervention Type: BIOLOGICAL

Given IV

cyclophosphamide

Intervention Type: DRUG

Given IV

prednisone

Intervention Type: DRUG

Given orally

vincristine sulfate

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

filgrastim

Intervention Type: BIOLOGICAL

Given subcutaneously

pegfilgrastim

Intervention Type: BIOLOGICAL

Given subcutaneously

rituximab

Intervention Type: BIOLOGICAL

Given IV

cyclophosphamide

Intervention Type: DRUG

Given IV

liposome-encapsulated doxorubicin citrate

Intervention Type: DRUG

Given IV

prednisone

Intervention Type: DRUG

Given orally

vincristine sulfate

Intervention Type: DRUG

Given IV

Interventions

filgrastim

Given subcutaneously

Intervention Type: BIOLOGICAL

pegfilgrastim

Given subcutaneously

Intervention Type: BIOLOGICAL

rituximab

Given IV

Intervention Type: BIOLOGICAL

cyclophosphamide

Given IV

Intervention Type: DRUG

liposome-encapsulated doxorubicin citrate

Given IV

Intervention Type: DRUG

prednisone

Given orally

Intervention Type: DRUG

vincristine sulfate

Given IV

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• No cerebral or meningeal involvement

PATIENT CHARACTERISTICS:

• WHO performance status 0-3
• ANC > 750/mm^3
• Platelet count > 50,000/mm^3
• LVEF > 35%
• Able to receive either R-COP or R-COPY therapy
• No congestive heart failure, serious arrhythmia, or myocardial infarction within the past 6 months
• No other malignancy within the past 5 years except for adequately treated basal cell carcinoma of the skin or curatively treated carcinoma in situ of the cervix
• No active infection
• No active viral hepatitis B or C by serology
• No known HIV positivity
• No hypersensitivity to rituximab, any of its excipients, or to murine proteins
• No documented history of allergy to eggs or egg products
• No psychological, familial, sociological, or geographical condition that would preclude compliance with study treatment or follow-up schedule

PRIOR CONCURRENT THERAPY:

• No prior therapy for this cancer
• No prior anthracycline administration with a cumulative dose > 240 mg/m² of doxorubicin hydrochloride or > 400 mg/m² of epirubicin hydrochloride
• More than 30 days since prior participation in another clinical trial involving investigational drugs
• No other concurrent antineoplastic agents

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Soubeyran, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Bergonié

Locations

Institut Bergonie

Bordeaux, , France

Countries

France

Other Identifiers

IB-FRAIL06

Identifier Type: OTHER

Identifier Source: secondary_id

INCA-RECF0892

Identifier Type: OTHER

Identifier Source: secondary_id

EUDRACT-2008-001506-16

Identifier Type: OTHER

Identifier Source: secondary_id

IB-2008-25

Identifier Type: -

Identifier Source: org_study_id