Marrow-Ablative Chemo-Radiotherapy and Autologous Stem Cell Transplantation Followed by Interferon-Alpha Maintenance Treatment Versus Interferon-Alpha Maintenance Treatment Alone After a Chemotherapy-Induced Remission in Patients With Stages III or IV Follicular Non-Hodgkin's Lymphoma. A Prospective, Randomized, Phase III Clinical Trial.
filgrastim
+ recombinant interferon alfa
+ cyclophosphamide
Hemic and Lymphatic Diseases+7
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: March 1, 1997
Actual date on which the first participant was enrolled.OBJECTIVES: I. Compare the progression free and overall survival, toxicity, and mortality of marrow ablative chemo/radiotherapy in addition to peripheral blood stem cell transplantation and interferon alfa maintenance therapy versus interferon alfa maintenance therapy alone in patients with follicular non-Hodgkin's lymphoma. OUTLINE: This is a randomized study. All patients receive 8 courses of cyclophosphamide/vincristine/prednisone (CVP) chemotherapy. Cyclophosphamide and vincristine IV are given on day 1, along with oral prednisone on days 1-5. Courses are repeated every 3 weeks. Patients are randomized to receive one of two treatments 4 weeks after completion of CVP chemotherapy if a partial or complete response is achieved and there are less than 15% monoclonal B-lymphocytes in the bone marrow. Patients randomized to arm I receive interferon alfa subcutaneously 3 times per week for a maximum of 3 years. Patients randomized to arm II receive cyclophosphamide IV followed by subcutaneous filgrastim (granulocyte colony-stimulating factor; G-CSF). Leukapheresis begins after leukocyte, platelet, and CD34+ levels recover and lasts 3-4 hours on 2-3 consecutive days. If an insufficient number of stem cells are collected from the peripheral blood, bone marrow harvesting is performed. After stem cell collection, a conditioning regimen consisting of cyclophosphamide IV on days -4 and -3 and total body irradiation on day -1 is administered. Stem cells are infused on day 0. If granulocyte and platelet counts recover within 8 weeks, patients receive interferon alfa maintenance therapy as in arm I. Patients are followed every 4 months until death. PROJECTED ACCRUAL: A total of 469 patients will be accrued for this study within 5 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.469 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Previously untreated follicular stage III or IV non-Hodgkin's lymphoma At least one measurable mass PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Alkaline phosphatase and bilirubin less than 2.5 times upper limit of normal (ULN) (unless clearly related to NHL) Renal: Creatinine and BUN less than 2.5 times ULN (unless clearly related to NHL) Cardiovascular: No severe cardiac disease (e.g. severe heart failure requiring treatment or cardiac ejection fraction less than 45%) Neurologic: No neurologic disease Pulmonary: No pulmonary disease Other: Not pregnant No prior malignancies except nonmelanoma skin cancer or carcinoma in situ of the cervix Not HIV positive No psychiatric or metabolic disease PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent immunotherapeutic drugs, chemotherapy, or radiotherapy
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Addenbrooke's NHS Trust
Cambridge, United Kingdom