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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rituxan
BEAM
Autologous stem cell transplant
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Nebraska Medical Center, Section of Oncology/Hematology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I Rituxan and BEAM post-autologous stem cell transplant

Arm Description

Rituxan and BEAM [Carmustine (BCNU), Etoposide, Cytarabine (Ara-C, cytosine arabinoside), Melphalan] will be a pre- and post-transplant agent to aid in the chemotherapy sensitization post-autologous stem cell transplant.

Outcomes

Primary Outcome Measures

Response rate
Disease response at day 100

Secondary Outcome Measures

Overall survival
Survival time from diagnosis until death

Full Information

First Posted
December 11, 2007
Last Updated
September 3, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT00572013
Brief Title
Rituxan and BEAM With Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma
Official Title
A Phase I/II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 12, 1998 (Actual)
Primary Completion Date
January 1, 2001 (Actual)
Study Completion Date
September 18, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I Rituxan and BEAM post-autologous stem cell transplant
Arm Type
Experimental
Arm Description
Rituxan and BEAM [Carmustine (BCNU), Etoposide, Cytarabine (Ara-C, cytosine arabinoside), Melphalan] will be a pre- and post-transplant agent to aid in the chemotherapy sensitization post-autologous stem cell transplant.
Intervention Type
Drug
Intervention Name(s)
Rituxan
Other Intervention Name(s)
Rituximab
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
BEAM
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Autologous stem cell transplant
Intervention Description
following chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line
Primary Outcome Measure Information:
Title
Response rate
Description
Disease response at day 100
Time Frame
100 day
Secondary Outcome Measure Information:
Title
Overall survival
Description
Survival time from diagnosis until death
Time Frame
diagnosis until death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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). o 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 WHO performance status greater or equal to 2 Male or female subjects of reproductive potential who are able to follow accepted birth control measures. Exclusion Criteria: No history of T-cell lymphoma Not pregnant or lactating women No serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie M Vose, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center, Section of Oncology/Hematology
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

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

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