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

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ClinicalTrials.gov Identifier: NCT00572013
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : December 16, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Rituxan Drug: BEAM Procedure: Autologous stem cell transplant Phase 1 Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 1998
Primary Completion Date : January 2001
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. response rate [ Time Frame: 100 day ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: diagnosis until death ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Nebraska
ClinicalTrials.gov Identifier: NCT00572013     History of Changes
Other Study ID Numbers: 138-98
IRB#138-98
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: December 2013

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