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

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ClinicalTrials.gov Identifier: NCT00080886

Recruitment Status : Completed

First Posted : April 8, 2004

Last Update Posted : January 24, 2018

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

R. Gregory Bociek, MD, University of Nebraska

Tracking Information

First Submitted Date ^ICMJE

April 7, 2004

First Posted Date ^ICMJE

April 8, 2004

Last Update Posted Date

January 24, 2018

Study Start Date ^ICMJE

May 2002

Actual Primary Completion Date

November 2005 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: 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.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Lymphoma

Intervention ^ICMJE

Biological: rituximab
Drug: carmustine
Drug: cytarabine
Drug: etoposide
Drug: melphalan
Procedure: autologous bone marrow transplantation
Procedure: peripheral blood stem cell transplantation

Study Arms ^ICMJE

Arm 1

Interventions:

Biological: rituximab
Drug: carmustine
Drug: cytarabine
Drug: etoposide
Drug: melphalan
Procedure: autologous bone marrow transplantation
Procedure: peripheral blood stem cell transplantation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date ^ICMJE

March 2015

Actual Primary Completion Date

November 2005 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

19 Years to 120 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00080886

Other Study ID Numbers ^ICMJE

063-02
CDR0000357306 ( Registry Identifier: PDQ (Physician Data Query) )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

R. Gregory Bociek, MD, University of Nebraska

Study Sponsor ^ICMJE

University of Nebraska

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Robert G Bociek, MD

University of Nebraska

PRS Account

University of Nebraska

Verification Date

January 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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