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Rituxan and BEAM With Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00572013
First received: December 11, 2007
Last updated: August 31, 2011
Last verified: August 2011
History of Changes

December 11, 2007
August 31, 2011
May 1998
September 2009   (final data collection date for primary outcome measure)
response rate [ Time Frame: 100 day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00572013 on ClinicalTrials.gov Archive Site
overall survival [ Time Frame: diagnosis until death ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Rituxan and BEAM With Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma
A Phase I/II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma

To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant.

Objectives: I. To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant. II. To determine if the addition of Rituxan changes the toxicity profile attributed to high-dose BEAM chemotherapy.

This protocol is a phase I/II trial combining the Rituxan as a pre and post-transplant agent to aid in the chemotherapy sensitization and the treatment of minimal residual disease post-transplant.
Interventional
Phase 1
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Drug: Rituxan
    375mg/m2 IV on days -20 to -8. Infusion to begin at rate of 50mg/hour for 1st hour.If no toxicity rate may be increased. A second infusion 375mg/m2 given 30days post transplant and again at 60 days post transplant
    Other Name: Rituximab
  • Drug: BEAM
    BCNU(carmustine)on day -6 300mg/M2 IV, etoposide 100mg/M2 BID on days -5 through -2, cytarabine 100mg/m2 BID on days -5 through -2, melphalan 140mg/m2 IV on day -1
  • Procedure: Autologous stem cell transplant
    following chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line
Experimental: Arm I
Interventions:
  • Drug: Rituxan
  • Drug: BEAM
  • Procedure: Autologous stem cell transplant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any low-grade B-cell, CD20 positive, non-Hodgkin's lymphoma that is felt to otherwise be a transplant candidate (relapsed, induction failure, first PR or CR). Specifically: Small lymphocytic, marginal zone, mantle cell, and follicular histologies.
  • At least 19 years of age
  • Signed written informed consent
  • Expected survival of at least 6 months
  • Subjects with out history of T-cell lymphoma
  • WHO performance status greater or equal to 2
  • Subjects without serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study.
  • Non-pregnant and non-lactating women
  • Male or female subjects of reproductive potential who are able to follow accepted birth control measures.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00572013
138-98, IRB#138-98
Yes
University of Nebraska
University of Nebraska
Not Provided
Principal Investigator: Julie M Vose, M.D. University of Nebraska
University of Nebraska
August 2011

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