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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


N/A
16 Years
65 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to transplantation, relapse rates, and event free survival

Outcome Time Frame:

follow up to death

Safety Issue:

No

Principal Investigator

Julie M Vose, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska

Authority:

United States: Institutional Review Board

Study ID:

123-92

NCT ID:

NCT00574626

Start Date:

December 1991

Completion Date:

May 2010

Related Keywords:

  • Lymphoma
  • NHL
  • Non Hodgkins Lymphoma
  • BMT
  • Bone Marrow Transplant
  • PBSCT
  • Peripheral Blood Stem Cell Transplant
  • PSCT
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

University of Nebraska Medical CenterOmaha, Nebraska  68198-3330