Rituximab and Carmustine, Cytarabine, Etoposide, and Melphalan Followed By Autologous Hematopoietic Stem Cell Transplantation in Treating Patients With B-Cell Non-Hodgkin's Lymphoma

Sponsor

University of Nebraska (Other)

Overall Status

Completed

CT.gov ID

NCT00080886

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

154

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Biological: rituximab Drug: carmustine Drug: cytarabine Drug: etoposide Drug: melphalan Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Trial Of BEAM/Rituximab/Autologous Hematopoietic Stem Cell Transplantation (AHSCT) For Patients With CD20 Positive Non-Hodgkin's Lymphoma

Study Start Date :

May 1, 2002

Actual Primary Completion Date :

Nov 1, 2005

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm 1	Biological: rituximab Drug: carmustine Drug: cytarabine Drug: etoposide Drug: melphalan Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation

Arm

Intervention/Treatment

Other: Arm 1

Biological: rituximab

Drug: carmustine

Drug: cytarabine

Drug: etoposide

Drug: melphalan

Procedure: autologous bone marrow transplantation

Procedure: peripheral blood stem cell transplantation

Outcome Measures

Primary Outcome Measures

evaluation of the relationship between levels of sCD20 in the blood of patients with non-Hodgkin's lymphoma pre and post rituximab/BEAM/autologous peripheral blood progenitor cell transplantation (PBPCT) as they relate to clinical outcomes. [pre and post transplant]
To evaluate levels of soluble CD20 antigen (sCD20) in the blood of patients with non-Hodgkin's lymphoma pre and post rituximab/BEAM/autologous hematopoietic stem cell transplantation (AHSCT), and to examine the effect of changes in levels of sCD20 with clinical outcomes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Diagnosis of non-Hodgkin's lymphoma
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
No history of T-cell lymphoma

PATIENT CHARACTERISTICS:

Age

19 and over

Performance status

WHO 0-2

Life expectancy

At least 6 months

Hematopoietic

Absolute neutrophil count ≥ 1,000/mm^3*
Platelet count > 50,000/mm^3*
Hemoglobin > 9.0 g/dL* NOTE: *Unless due to lymphomatous involvement of the bone marrow

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant or nursing
Fertile patients must use 2 methods of effective contraception
No other concurrent serious disease or condition that would preclude study participation