Comparing Autologous Peripheral Blood Stem Cell to Bone Marrow Transplantation for Recurrent Non-Hodgkin's Lymphoma

December 20, 2023 updated by: University of Nebraska

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 bone marrow (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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peripheral Blood Stem Cell Transplant
Procedure: PBSCT
Peripheral Blood Stem Cell Transplant
Active Comparator: Bone Marrow Transplantation
Procedure: Bone Marrow Transplant
Bone Marrow Transplant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New Blood Cell Production Response
Time Frame: From date of transplant until death (up to 220 months)
Production of new blood cells after transplantation
From date of transplant until death (up to 220 months)
Percentage of Participants with Relapse
Time Frame: From date of transplant until death (up to 220 months)
Percentage of participants with recurrence (return of cancer)
From date of transplant until death (up to 220 months)
Percentage of participants with event free survival
Time Frame: From date of transplant until death (up to 220 months)
Percentage of participants with event free survival (no relapse or progression)
From date of transplant until death (up to 220 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Julie M Vose, MD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 1991

Primary Completion (Actual)

May 5, 2010

Study Completion (Actual)

May 5, 2010

Study Registration Dates

First Submitted

December 12, 2007

First Submitted That Met QC Criteria

December 14, 2007

First Posted (Estimated)

December 17, 2007

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0123-92-FB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe