Combination Chemotherapy With or Without Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2017-07-19
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether chemotherapy is more effective with or without rituximab for relapsed non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab to see how well they work compared to combination chemotherapy alone in treating patients with relapsed non-Hodgkin's lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborators: Australasian Leukaemia and Lymphoma Group; Lymphoma Trials Office; NCIC Clinical Trials Group; Nordic Lymphoma Group; Stichting Hemato-Oncologie voor Volwassenen Nederland
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven stage III or IV follicular non-Hodgkin's lymphoma (NHL)

• Relapsed after or no response (no change/progressive disease) to no more than 2 adequate non-anthracycline-containing systemic chemotherapy regimens

• At least 2 months of single-agent therapy (e.g., chlorambucil) AND/OR

• At least 2 consecutive courses of polychemotherapy (e.g., cyclophosphamide, vincristine, and prednisone) or purine analogues

• Complete or partial remission or no change for at least 4 weeks after completion of prior therapy OR progression during one of a maximum of 2 prior therapy regimens

• CD20 positive

• At least 1 bidimensionally measurable mass

• No greater than 10,000,000/mL circulating tumor cells

• IgG levels at least 3 g/L

• No low-grade NHL transformed into intermediate- or high-grade NHL

• No symptomatic CNS lymphoma

• No bone marrow involvement only NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin less than 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase less than 2.5 times ULN

Renal:

• Creatinine less than 2.5 times ULN

• BUN less than 2.5 times ULN

Cardiovascular:

• No severe cardiac disease (i.e., severe heart failure requiring symptomatic treatment)

Pulmonary:

• No severe pulmonary disease

Other:

• No severe neurologic or psychiatric disease

• No severe metabolic disease

• Not pregnant

• Fertile patients must use effective contraception

• No prior malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of the cervix, or other cancer curatively treated with surgical therapy

• HIV negative

• No uncontrolled asthma or allergy requiring steroids

• No known hypersensitivity or prior anaphylactic reaction to murine proteins or any component of study drug

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior rituximab

• No prior allogeneic or autologous peripheral blood stem cell transplantation

• Concurrent filgrastim (G-CSF) for stem cell mobilization allowed

Chemotherapy:

• See Disease Characteristics

• No prior anthracyclines or mitoxantrone

• No concurrent chemotherapy for stem cell mobilization

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified