Randomized Trial Comparing Autologous PBSCT to BMT for Pts Receiving High-Dose Chemo & Transplant for Recurrent NHL
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 16 - 65 |
| Updated: | 1/19/2018 |
| Start Date: | December 1991 |
| End Date: | May 2010 |
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.
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.
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.
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.
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.
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