Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive B-Cell Diffuse Large Cell Lymphoma

NCT00052923 | Completed Phase 3

• 4 other identifiers: CDR0000258802ECOG-E2499CALGB-50205CALGB-E2499
• Study Type: interventional
• Target: 427
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies, such as rituximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether stem cell transplantation is more effective with or without rituximab in treating relapsed or progressive B-cell diffuse large cell lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of stem cell transplantation with or without rituximab in treating patients who have relapsed or progressive B-cell diffuse large cell lymphoma.

Conditions

Lymphoma

Keywords

recurrent adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

Secondary Outcomes (3)

• Procedure-related mortality

• Overall survival

• Potential infectious complications of the addition of rituximab to autologous stem cell transplantation

Interventions

filgrastim BIOLOGICAL

rituximab BIOLOGICAL

carmustine DRUG

cyclophosphamide DRUG

etoposide DRUG

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of diffuse large cell lymphoma and meeting the following criteria: * B-cell type with expression of CD20 either at diagnosis or at relapse * Relapse after having achieved an initial complete remission (CR) or failure to achieve initial CR (residual radiographic abnormalities after primary therapy allowed if these abnormalities are also positive by positron emission tomography or MRI \[gallium\]) * No newly diagnosed disease * No progressive or stable disease to most recent salvage therapy PATIENT CHARACTERISTICS: Age * 18 to 70 Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 2.0 mg/dL * AST or ALT \< 3 times upper limit of normal Renal * Creatinine ≤ 2.0 mg/dL OR * Creatinine clearance ≥ 40 mL/min Cardiovascular * Cardiac ejection fraction ≥ 40% Pulmonary * DLCO ≥ 60% of predicted Other * No other malignancy within the past 2 years except basal cell skin cancer or carcinoma in situ of the cervix * No active infection requiring oral or IV antibiotics * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * See Chemotherapy * No more than 3 prior immunotherapy regimens Chemotherapy * No more than 3 prior chemotherapy regimens * Addition of radiation or a monoclonal antibody to chemotherapy is considered one treatment regimen if the addition was part of the initial treatment plan * Addition of these therapies due to lack of response or poor response would be considered an additional treatment regimen whether given in front-line or salvage setting Endocrine therapy * Not specified Radiotherapy * See Chemotherapy * No more than 3 prior radiotherapy regimens * No prior radioimmunotherapy Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• Cancer and Leukemia Group B: collaborator

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse

Interventions

Filgrastim; Rituximab; Carmustine; Cyclophosphamide; Etoposide; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Ian W. Flinn, MD, PhD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

• Charles A. Linker, MD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: January 24, 2003
• First Posted: January 27, 2003
• Study Start: March 1, 2003
• Primary Completion: June 1, 2006
• Last Updated: February 9, 2009

Record last verified: 2006-06