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Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia

2014-08-27 03:18:09 | BioPortfolio

Summary

RATIONALE: Peripheral blood stem cell transplant using stem cells from the patient or a donor may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells. These donated stem cells may help destroy cancer cells (graft-versus-tumor effect).

PURPOSE: This study was designed to combine two types of stem cell transplant. The first would be the use of high-dose chemotherapy and autologous stem cell transplantation (using your own stem cells). This type of stem cell transplant has the advantage of no GVHD and very low risk of death, while minimizing the number of cancer cells. Then, the investigators will wait for a period between 40-120 days to allow your body to recover from the high-dose chemotherapy. Then, you will receive the second type of transplant "nonmyeloablative transplant" from your haploidentical family donor. The investigators hope that the donor cells will then eliminate any remaining tumor cells.

We are doing this study: -To see if the combined stem cell transplant will help prevent the blood or lymph nodes' cancer from coming back. -To see if the combined stem cell transplant will be safe with no increased toxicities or deaths compared to "nonmyeloablative transplant" alone.

Description

PRIMARY OBJECTIVES:

I. Event-free survival at 1-year after autograft.

SECONDARY OBJECTIVES:

I. Relapse rates at 1-year after autograft. II. Overall survival at 1-year after autograft. III. Incidence of grades II-IV acute GVHD and chronic extensive GVHD. IV. NRM at 200 days and 1 year after allograft. V. Donor engraftment at day +84. VI. Incidence of infections.

OUTLINE:

CONDITIONING REGIMEN 1 (lymphoma or chronic lymphocytic leukemia [CLL] without prior total-body irradiation [TBI]): Patients receive cyclophosphamide IV on days -6 and -5. Patients undergo high-dose TBI twice daily on days -3 to -1.

CONDITIONING REGIMEN 2 (lymphoma, Waldenstrom Macroglobulinemia, CLL, older patients, or with prior dose-limiting radiation): Patients receive carmustine IV on day -7, etoposide IV twice daily on days -6 to -3, cytarabine IV twice daily on days -6 to -3, and melphalan IV on day -2.

CONDITIONING REGIMEN 3 (multiple myeloma or plasma cell leukemia, young patients with no significant medical problems): Patients receive high-dose melphalan IV on day -2.

CONDITIONING REGIMEN 4 (multiple myeloma or plasma cell leukemia, older patients or with significant medical problems): Patients receive lessened dose of melphalan IV on day -2.

AUTOLOGOUS PERIPHERAL BLOOD STEM CELL (PBSC) TRANSPLANTATION: All patients undergo autologous PBSC transplantation on day 0.

WAITING INTERVAL: Between 40 and 120 days.

NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV once daily on days -6 to -2 and cyclophosphamide IV once daily on days -6 to -5 and day 3. Patients undergo low-dose TBI on day -1.

ALLOGENEIC BONE MARROW TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0.

GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Beginning on day 4, patients receive IV or oral tacrolimus and taper beginning on day 86 if no graft-versus-host disease. Patients also receive oral mycophenolate mofetil three times daily on days 4 - 35.

PERIPHERAL BLOOD COUNT SUPPORT: Patients receive filgrastim (G-CSF) IV or SC beginning from day 4 and continue till blood counts recover.

After completion of study treatment, patients are followed periodically for 5 years.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Adult Nasal Type Extranodal NK/T-cell Lymphoma

Intervention

carmustine, etoposide, cytarabine, fludarabine phosphate, cyclophosphamide, tacrolimus, mycophenolate mofetil, total-body irradiation, melphalan, autologous-allogeneic tandem hematopoietic stem cell transplantation, autologous hematopoietic stem cell tran

Location

Fred Hutchinson Cancer Research Center
Seattle
Washington
United States
98109

Status

Recruiting

Source

Fred Hutchinson Cancer Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:09-0400

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Medical and Biotech [MESH] Definitions

A semisynthetic derivative of PODOPHYLLOTOXIN that exhibits antitumor activity. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. This complex induces breaks in double stranded DNA and prevents repair by topoisomerase II binding. Accumulated breaks in DNA prevent entry into the mitotic phase of cell division, and lead to cell death. Etoposide acts primarily in the G2 and S phases of the cell cycle.

A 12-KDa tacrolimus binding protein that is found associated with and may modulate the function of calcium release channels. It is a peptidyl-prolyl cis/trans isomerase which is inhibited by both tacrolimus (commonly called FK506) and SIROLIMUS.

Congener of CYTARABINE that is metabolized to cytarabine and thereby maintains a more constant antineoplastic action.

A family of immunophilin proteins that bind to the immunosuppressive drugs TACROLIMUS (also known as FK506) and SIROLIMUS. EC 5.2.1.-

A pyrimidine nucleoside analog that is used mainly in the treatment of leukemia, especially acute non-lymphoblastic leukemia. Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA. Its actions are specific for the S phase of the cell cycle. It also has antiviral and immunosuppressant properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p472)

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