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

Study Overview
=================
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.

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

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Procedure: PBSCT
* Procedure: Bone Marrow Transplant


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripheral Blood Stem Cell Transplant<br>Peripheral Blood Stem Cell Transplant | Procedure: PBSCT<br>* Peripheral Blood Stem Cell Transplant<br>|
| Active Comparator: Bone Marrow Transplantation<br>Bone Marrow Transplantation | Procedure: Bone Marrow Transplant<br>* Bone Marrow Transplant<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NHL, Non Hodgkins Lymphoma, BMT, Bone Marrow Transplant, PBSCT, Peripheral Blood Stem Cell Transplant, PSCT