A Phase II Trial Of BEAM/Rituximab/Autologous Hematopoietic Stem Cell Transplantation (AHSCT) For Patients With CD20 Positive Non-Hodgkin's Lymphoma
rituximab
+ carmustine
+ cytarabine
Immune System Diseases+5
+ Immunoproliferative Disorders
+ Lymphatic Diseases
Treatment Study
Summary
Study start date: May 8, 2002
Actual date on which the first participant was enrolled.OBJECTIVES: * Determine the levels of soluble CD20 antigen (sCD20) in the blood before and after treatment with rituximab and carmustine, cytarabine, etoposide, and melphalan followed by autologous hematopoietic stem cell transplantation in patients with CD20-positive B-cell non-Hodgkin's lymphoma. * Correlate the effect of changes in levels of sCD20 with clinical outcomes in patients treated with this regimen. * Determine the response rate in patients treated with this regimen. * Determine the event-free survival of patients treated with this regimen. * Determine the toxicity profile of this regimen in these patients. OUTLINE: Patients receive rituximab IV over approximately 3-4 hours once weekly for 2 weeks followed 1 week later by hematopoietic stem cell or bone marrow harvest. Patients then receive a third dose of rituximab IV over approximately 3-4 hours on day -7 or -6. Patients also receive high-dose chemotherapy comprising carmustine IV on day -6, cytarabine IV and etoposide IV twice daily on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous hematopoietic stem cell transplantation on day 0. Patients who have less than a complete remission at day 100 post-transplantation receive 4 additional doses of rituximab IV over approximately 3-4 hours once weekly for 4 weeks. Patients are followed at day 100, at 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.68 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 19 to 120 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
Inclusion Criteria: * Diagnosis of non-Hodgkin's lymphoma o Any B cell * CD20-positive disease * Failed prior primary induction therapy * Meets 1 of the following criteria: * Chemotherapy-refractory disease * Received at least 3 prior chemotherapy regimens * Mantle cell lymphoma * Eligible for transplantation * 19 years old and over * WHO 0-2 * Life expectancy at least 6 months * Absolute neutrophil count ≥ 1,000/mm\^3\* * Platelet count \> 50,000/mm\^3\* * Hemoglobin \> 9.0 g/dL\* o NOTE: \*Unless due to lymphomatous involvement of the bone marrow * Fertile patients must use 2 methods of effective contraception Exclusion Criteria: * No history of T-cell lymphoma * Not pregnant or nursing * No other concurrent serious disease or condition that would preclude study participation
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
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 1 location