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Randomized Trial Comparing Autologous PBSCT to BMT for Pts Receiving High-Dose Chemo & Transplant for Recurrent NHL

Primary Purpose

Lymphoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PBSCT
Bone Marrow Transplant
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring NHL, Non Hodgkins Lymphoma, BMT, Bone Marrow Transplant, PBSCT, Peripheral Blood Stem Cell Transplant, PSCT

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 16-65
  • Intermediate grade non-Hodgkin's lymphoma (International Working Formulation - Follicular large cell, Diffuse Small Cleaved, Diffuse Mixed, Diffuse Large Cell, and Immunoblastic) with histologic negative bone marrow who would otherwise meet all eligibility criteria for high-dose therapy and ABMT. These criteria are in each specific high-dose therapy protocol (i.e. Karnofsky performance status > 70, adequate organ function, HIV and Hepatitis B negative, etc.). These patients would be enrolled in a high-dose protocol using carmustine, etoposide, cytarabine, and cytoxan (BEAC) with autologous hematopoietic rescue.

Exclusion Criteria:

  • Patients with bone marrow histologically involved with tumor or with a bone marrow abnormality making bone marrow harvest not possible.
  • Patients whose tumor is rapidly growing which may preclude the extra time involved with the PSC collection process.
  • Patients who do not otherwise meet high-dose therapy and transplantation entry criteria.

Sites / Locations

  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PBSCT

BMT

Arm Description

Peripheral Blood Stem Cell Transplant

Bone Marrow Transplantation

Outcomes

Primary Outcome Measures

Response to transplantation, relapse rates, and event free survival

Secondary Outcome Measures

Full Information

First Posted
December 12, 2007
Last Updated
January 13, 2018
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT00574626
Brief Title
Randomized Trial Comparing Autologous PBSCT to BMT for Pts Receiving High-Dose Chemo & Transplant for Recurrent NHL
Official Title
Randomized Trial Comparing Autologous Peripheral Blood Stem Cell Transplantation to Bone Marrow Transplantation for Patients Receiving High-Dose Chemotherapy and Transplantation for Recurrent Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 1991 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the difference in relapse rates and long term event free survival in patients with intermediate grade or immunoblastic non-Hodgkin's lymphoma (NHL) whose marrow is not obviously involved with NHL who are randomized to receive either an autologous bone marrow (ABMT) or peripheral stem cell transplant (PSCT). All patients with intermediate grade NHL with histologic negative bone marrow who would otherwise meet all eligibility criteria for high-dose therapy and ABMT are eligible for this study. Patients who are eligible will be randomized to either PSCT or ABMT at the time of enrollment into our transplant program.
Detailed Description
These patients would be enrolled in a high-dose protocol using carmustine, etoposide, cytarabine, and cytoxan (BEAC) with autologous hematopoietic rescue. The patients will be stratified according to good and poor prognosis category and relapsed vs. first partial response categories. The patients will have bone marrow or peripheral stem cells collected according to standard protocols. A standardized hematopoietic growth factor will be used for mobilization and post-transplant. The patients' PSC or BM product will be assayed via invitro-culture techniques for occult tumor, and by molecular biologic assays. The patients' outcome for transplantation will be evaluated with response to transplantation, relapse rates and event free survival being the measured end points.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
NHL, Non Hodgkins Lymphoma, BMT, Bone Marrow Transplant, PBSCT, Peripheral Blood Stem Cell Transplant, PSCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PBSCT
Arm Type
Experimental
Arm Description
Peripheral Blood Stem Cell Transplant
Arm Title
BMT
Arm Type
Active Comparator
Arm Description
Bone Marrow Transplantation
Intervention Type
Procedure
Intervention Name(s)
PBSCT
Intervention Description
Peripheral Blood Stem Cell Transplant
Intervention Type
Procedure
Intervention Name(s)
Bone Marrow Transplant
Intervention Description
Bone Marrow Transplant
Primary Outcome Measure Information:
Title
Response to transplantation, relapse rates, and event free survival
Time Frame
follow up to death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 16-65 Intermediate grade non-Hodgkin's lymphoma (International Working Formulation - Follicular large cell, Diffuse Small Cleaved, Diffuse Mixed, Diffuse Large Cell, and Immunoblastic) with histologic negative bone marrow who would otherwise meet all eligibility criteria for high-dose therapy and ABMT. These criteria are in each specific high-dose therapy protocol (i.e. Karnofsky performance status > 70, adequate organ function, HIV and Hepatitis B negative, etc.). These patients would be enrolled in a high-dose protocol using carmustine, etoposide, cytarabine, and cytoxan (BEAC) with autologous hematopoietic rescue. Exclusion Criteria: Patients with bone marrow histologically involved with tumor or with a bone marrow abnormality making bone marrow harvest not possible. Patients whose tumor is rapidly growing which may preclude the extra time involved with the PSC collection process. Patients who do not otherwise meet high-dose therapy and transplantation entry criteria.
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
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Randomized Trial Comparing Autologous PBSCT to BMT for Pts Receiving High-Dose Chemo & Transplant for Recurrent NHL

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