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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
 (submitted: April 17, 2013)
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
 (submitted: April 17, 2013)
68
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 No
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