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Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00007852
Recruitment Status : Completed
First Posted : February 12, 2004
Last Update Posted : March 26, 2012
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Genentech, Inc.
Information provided by (Responsible Party):
Julie M Vose, MD, University of Nebraska

Tracking Information
First Submitted Date  ICMJE January 6, 2001
First Posted Date  ICMJE February 12, 2004
Last Update Posted Date March 26, 2012
Study Start Date  ICMJE September 2000
Actual Primary Completion Date January 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2010)
The primary endpoint for this study is 100 day (complete + partial) response rate [ Time Frame: 100 days ]
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 Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Official Title  ICMJE A Phase II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for 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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab and combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES: I. Determine the complete and partial response rate of patients with relapsed or refractory B-cell non-Hodgkin's lymphoma treated with rituximab and high-dose carmustine, etoposide, cytarabine and melphalan followed by autologous bone marrow or peripheral blood stem cell transplantation. II. Determine the toxicity profile of this regimen in these patients. III. Compare the levels of soluble CD20 antigen and rituximab blood levels with patient outcomes in this patient population.

OUTLINE: Patients receive two doses of rituximab IV over 3-4 hours 1 week apart. Stem cells from the peripheral blood or bone marrow are collected at least 1 week after the second dose of rituximab. Following stem cell collection, patients receive a third dose of rituximab IV as above between days -10 and -6. Patients then receive high-dose chemotherapy consisting of carmustine IV on day -6, etoposide IV twice daily and cytarabine IV on days -5 to -2, and melphalan IV on day -1. On day 0 patients undergo autologous bone marrow or peripheral blood stem cell transplantation. After transplantation, patients receive a fourth dose of rituximab as above at approximately day 30, and then weekly over 4 weeks at approximately 6 months in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 year and then annually thereafter.

PROJECTED ACCRUAL: A total of 23-40 patients will be accrued for this study within 3 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • Biological: rituximab
    Rituximab at 375 mg/m2 administered approximately one week apart prior to collection of the hematopoietic stem cells. Rituxan at a dose of 375 mg/m2 IV will be given either on the days prior to initiation of the BCNU (days -10 to -7) or on the same day that the BCNU is administered for the BEAM chemotherapy regimen (Day -6). A fourth infusion of Rituxan 375 mg/m2 will be given at 30 day (+/- 20 days) post-transplant. At approximately 6 months post-transplant, if the patients have not had progressive lymphoma, they will receive four weekly doses of Rituxan 375 mg/m2 IV.
    Other Name: Rituxan
  • Drug: carmustine
    BCNU 300 mg/M2 IV day -6
    Other Name: BCNU
  • Drug: cytarabine
    100 mg/m2 on days -5 through -2
    Other Name: BEAM chemotherapy regimen
  • Drug: etoposide
    100mg/M2 BID on days -5 through -2
    Other Name: BEAM chemotherapy regimen
  • Drug: melphalan
    140 mg/m2 IV on day -1
    Other Name: BEAM chemotherapy regimen
  • Procedure: autologous hematopoietic stem cell transplantation
    Following the chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line
Study Arms  ICMJE Experimental: Arm I
Rituxan and BEAM with autologous stem cell transplant
Interventions:
  • Biological: rituximab
  • Drug: carmustine
  • Drug: cytarabine
  • Drug: etoposide
  • Drug: melphalan
  • Procedure: autologous hematopoietic 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: November 1, 2010)
44
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS: Diagnosis of CD20-positive B-cell non-Hodgkin's lymphoma Transplantation candidate Primary induction failure Chemotherapy refractory disease Received at least 3 prior chemotherapy regimens OR Diagnosis of mantle cell lymphoma No history of T-cell lymphoma No relapse or progression after rituximab therapy within 3 months before transplantation

PATIENT CHARACTERISTICS: Age: 19 and over Performance status: WHO 0-2 Life expectancy: At least 6 months Hematopoietic: Absolute neutrophil count at least 1,000/mm3* Platelet count more than 50,000/mm3* Hemoglobin more than 9.0 g/dL* *Unless due to lymphomatous involvement of the marrow Hepatic: Not specified Renal: Not specified Other: No serious disease or condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids except for transient control or prevention of nausea or vomiting Concurrent non-steroidal hormones for non-lymphoma-related conditions (e.g., insulin for diabetes) allowed Radiotherapy: No concurrent external beam radiotherapy during transplantation therapy Surgery: Not specified Other: No other concurrent antitumoral or investigational agents

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (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 NCT00007852
Other Study ID Numbers  ICMJE 045-00
P30CA036727 ( U.S. NIH Grant/Contract )
UNMC-045-00
NCI-V00-1634
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julie M Vose, MD, University of Nebraska
Study Sponsor  ICMJE University of Nebraska
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Genentech, Inc.
Investigators  ICMJE
Study Chair: Julie M. Vose, MD University of Nebraska
PRS Account University of Nebraska
Verification Date March 2012

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