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| Sponsors and Collaborators: |
EBMT Solid Tumors Working Party Lymphoma Trials Office |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005589 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. 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 if combination chemotherapy plus peripheral stem cell transplantation is more effective with or without rituximab for non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: filgrastim Biological: rituximab Drug: carmustine Drug: cyclophosphamide Drug: cytarabine Drug: etoposide Drug: melphalan Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| Official Title: | Randomized Study of Rituximab (Mabthera) in Patients With Relapsed Follicular Lymphoma Prior to High-Dose Therapy as In Vivo Purging and to Maintain Remission Following High-Dose Therapy |
| Estimated Enrollment: | 460 |
| Study Start Date: | October 1999 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to type of remission (complete vs good partial) and which remission (second vs third). Patients are randomized to one of four treatment arms.
All patients receive induction chemotherapy comprising cyclophosphamide IV over 3-4 hours on day 0 or a standard induction chemotherapy regimen.
Filgrastim (G-CSF) is administered subcutaneously daily beginning on day 1.
Patients are then randomized to receive either in vivo rituximab purging or no purging following restaging after completion of induction. For those patients receiving purging (arms I and II), rituximab is administered IV once weekly for 4 weeks.
Peripheral blood stem cells (PBSC) are collected between days 8 and 12 post induction chemotherapy. Within 4 weeks of PBSC collection, patients receive carmustine IV over 2 hours on day -6, etoposide IV over 2 hours on days -5 to -2, cytarabine IV over 5 minutes twice daily on days -5 to -2, and melphalan IV over 10-15 minutes on day -1. (Alternatively, high dose cyclophosphamide and total body irradiation beginning 2-4 weeks after cyclophosphamide or standard induction chemotherapy priming is also allowed.) PBSC are reinfused on day 0.
Patients are further randomized to receive either rituximab maintenance or observation only. For those patients receiving maintenance (arms I and III), rituximab is administered IV once every 2 months for 4 doses beginning 30 days after PBSC reinfusion.
Patients are followed at 30 days, 3, 6, 9, and 12 months after PBSC transplant, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 460 patients (115 per treatment arm) will be accrued for this study within 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Relapsed or resistant follicular non-Hodgkin's lymphoma (NHL)
Achievement of complete remission (CR) or very good partial remission (VGPR) following reinduction chemotherapy with any standard regimen
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Show 131 Study Locations| Study Chair: | Ruth Pettengell, MD | St George's, University of London |
| Study Chair: | David C. Linch | Middlesex Hospital |
More Information
| Study ID Numbers: | CDR0000067665, EBMT-EBMTLYM1, BNLI-EBMT-EBMTLYM1, EU-99050 |
| Study First Received: | May 2, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00005589 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
|
Antimetabolites Melphalan Immunoproliferative Disorders Immunologic Factors Rituximab Carmustine Benzocaine Lymphoma, Follicular Cyclophosphamide Antiviral Agents Immunosuppressive Agents Etoposide phosphate |
Follicular Lymphoma Recurrence Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Alkylating Agents Etoposide Lymphoma Cytarabine |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Lymphoma, Follicular Cyclophosphamide Therapeutic Uses Lymphoma Alkylating Agents Cytarabine Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Rituximab Carmustine Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Antirheumatic Agents |
