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Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Cancer or Other Disease

2014-08-27 03:41:38 | BioPortfolio

Summary

RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing T cells from the donor cells before transplant and giving cyclosporine or tacrolimus before and after transplant may stop this from happening. Giving an infusion of the donor's T cells (donor lymphocyte infusion) later may help the patient's immune system see any remaining cancer or abnormal cells as not belonging to the patient's body and destroy them (graft-versus-tumor effect).

PURPOSE: This phase II trial is studying how well a donor peripheral blood stem cell transplant works in treating patients with hematologic cancer or other disease.

Description

OBJECTIVES:

- Determine the overall survival rate at day 200 in patients with hematologic cancers or other diseases who undergo allogeneic peripheral blood stem cell transplantation using the CliniMACS® CD34 Reagent System for T-cell depletion followed by delayed T-cell add-back.

- Determine the safety of this regimen, in terms of the nonrelapse mortality rate at day 200, in these patients.

OUTLINE:

- Myeloablative preparative regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -8 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Patients also undergo high-dose* total body irradiation (TBI) twice daily on days -7 to -4.

NOTE: *Patients over 55 years of age receive reduced-dose TBI.

- Allogeneic peripheral blood stem cell (PBSC) transplantation: Patients receive T-cell-depleted (via the CliniMACS® CD34 Reagent System), filgrastim (G-CSF)-mobilized, donor PBSC IV over 4 hours on day 0.

- Graft-versus-host-disease (GVHD) prophylaxis: Patients receive cyclosporine (or tacrolimus) IV or orally twice daily on days -6 to 21, and then again beginning on day 89 and continuing up to day 150, followed by a slow taper to day 180, in the absence of GVHD.

- Donor lymphocyte infusion (DLI): Patients receive delayed T-cell add-backs of donor lymphocytes IV over 1 hour on day 90. If relapse occurs, patients may receive DLI before day 90 or as a repeat infusion.

After completion of study therapy, patients are followed periodically for 3 years.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Chronic Myeloproliferative Disorders

Intervention

therapeutic allogeneic lymphocytes, cyclophosphamide, cyclosporine, fludarabine phosphate, tacrolimus, allogeneic hematopoietic stem cell transplantation, in vitro-treated peripheral blood stem cell transplantation, peripheral blood stem cell transplantat

Location

NIH - Warren Grant Magnuson Clinical Center
Bethesda
Maryland
United States
20892-1182

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:41:38-0400

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Medical and Biotech [MESH] Definitions

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.

Members of a family of highly conserved proteins which are all cis-trans peptidyl-prolyl isomerases (PEPTIDYLPROLYL ISOMERASE). They bind the immunosuppressant drugs CYCLOSPORINE; TACROLIMUS and SIROLIMUS. They possess rotamase activity, which is inhibited by the immunosuppressant drugs that bind to them.

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

A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed).

A macrolide isolated from the culture broth of a strain of Streptomyces tsukubaensis that has strong immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antigenic or mitogenic stimulation in vitro.

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