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

NCT00574626 | Completed

• 1 other identifier: 0123-92-FB
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma

Keywords

NHL; Non Hodgkins Lymphoma; BMT; Bone Marrow Transplant; PBSCT; Peripheral Blood Stem Cell Transplant; PSCT

Outcome Measures

Primary Outcomes (3)

• New Blood Cell Production Response

  Production of new blood cells after transplantation

  From date of transplant until death (up to 220 months)

• Percentage of Participants with Relapse

  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

  Percentage of participants with event free survival (no relapse or progression)

  From date of transplant until death (up to 220 months)

Study Arms (2)

Peripheral Blood Stem Cell Transplant

EXPERIMENTAL

Peripheral Blood Stem Cell Transplant

Procedure: PBSCT

Bone Marrow Transplantation

ACTIVE COMPARATOR

Bone Marrow Transplantation

Procedure: Bone Marrow Transplant

Interventions

PBSCT PROCEDURE

Peripheral Blood Stem Cell Transplant

Peripheral Blood Stem Cell Transplant

Bone Marrow Transplant PROCEDURE

Bone Marrow Transplant

Bone Marrow Transplantation

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Non-Hodgkin

Interventions

Bone Marrow Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Julie M Vose, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 17, 2007
• Study Start: December 12, 1991
• Primary Completion: May 5, 2010
• Study Completion: May 5, 2010
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

US (1)