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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
  Purpose

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


Condition Intervention Phase
Lymphoma
 Drug: Rituxan
Drug: BEAM
Procedure: Autologous stem cell transplant
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • response rate [ Time Frame: 100 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: diagnosis until death ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: May 1998
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572013

Locations
United States, Nebraska
University of Nebraska Medical Center, Section of Oncology/Hematology
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Julie M Vose, M.D. University of Nebraska
  More Information

No publications provided

Responsible Party: University of Nebraska
ClinicalTrials.gov Identifier: NCT00572013     History of Changes
Other Study ID Numbers: 138-98, IRB#138-98
Study First Received: December 11, 2007
Last Updated: August 31, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013