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

Not Applicable

Completed

• Conditions: Lymphoma
• Interventions: Procedure: PBSCT; Procedure: Bone Marrow Transplant

• Registration Number: NCT00574626
• Lead Sponsor: University of Nebraska

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 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 Timeline

• Study Start: 1991-12-12
• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-14
• Study First Posted: 2007-12-17
• Primary Completion: 2010-05-05
• Study Completion: 2010-05-05
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peripheral Blood Stem Cell Transplant	PBSCT	Peripheral Blood Stem Cell Transplant
Bone Marrow Transplantation	Bone Marrow Transplant	Bone Marrow Transplantation

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States