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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: December 13, 2013
Last verified: December 2013
  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:


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: January 2001 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: December 13, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014