Randomized Trial Comparing Autologous PBSCT to BMT for Pts Receiving High-Dose Chemo & Transplant for Recurrent NHL
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PBSCT Peripheral Blood Stem Cell Transplant |
Procedure: PBSCT
Peripheral Blood Stem Cell Transplant
|
| Active Comparator: BMT Bone Marrow Transplantation |
Procedure: Bone Marrow Transplant
Bone Marrow Transplant
|
Outcome Measures
Primary Outcome Measures
- Response to transplantation, relapse rates, and event free survival [follow up to death]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-7680 |
Sponsors and Collaborators
- University of Nebraska
Investigators
- Principal Investigator: Julie M Vose, MD, University of Nebraska
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 123-92