Rituximab, Carmustine; Cytarabine, Etoposide, & Melphalan; Stem Cell Transplantation for Non-Hodgkin's Lymphoma

NCT ID: NCT00080886

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-08
• Study Completion Date: 2015-03-12

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab and combination chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy followed by autologous hematopoietic stem cell transplantation in treating patients who have B-cell non-Hodgkin's lymphoma.

Detailed Description

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Participants 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.

Participants 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. Participants undergo autologous hematopoietic stem cell transplantation on day 0. Participants 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. Participants are followed at day 100, at 1 year, and then annually thereafter.

Group Type: OTHER

rituximab

Intervention Type: BIOLOGICAL

carmustine

Intervention Type: DRUG

cytarabine

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

melphalan

Intervention Type: DRUG

autologous bone marrow transplantation

Intervention Type: PROCEDURE

peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

Interventions

rituximab

Intervention Type: BIOLOGICAL

carmustine

Intervention Type: DRUG

cytarabine

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

melphalan

Intervention Type: DRUG

autologous bone marrow transplantation

Intervention Type: PROCEDURE

peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

Other Intervention Names

Rituxan; Gliadel Wafer, Bicnu; cytosine arabinoside; Etopophos, Toposar; Evomela

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert G Bociek, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center, Eppley Cancer Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

CDR0000357306

Identifier Type: REGISTRY

Identifier Source: secondary_id

0063-02-FB

Identifier Type: -

Identifier Source: org_study_id