Clinical Trials Directory

Trials / Completed

CompletedNCT00049504

Haploidentical Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancer

Nonmyeloablative Hematopoietic Stem Cell Transplantation for Patients With High-Risk Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Phase II Trial of Combined Immunosuppression Before and After Transplantation

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
53 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
—
Healthy volunteers
Not accepted

Summary

This phase II trial studies how well giving fludarabine phosphate, cyclophosphamide, tacrolimus, mycophenolate mofetil and total-body irradiation together with a donor bone marrow transplant works in treating patients with high-risk hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells by stopping them from dividing or killing them. Giving cyclophosphamide after transplant may also stop the patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem cells may replace the patient's immune system cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening

Detailed description

OBJECTIVES: I. To determine if engraftment can be achieved safely in patients with high-risk hematologic malignancies who undergo non-myeloablative bone marrow transplantation (BMT) from human leukocyte antigen (HLA)-haploidentical donors. OUTLINE: NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 1 hour on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total body irradiation on day -1. TRANSPLANTATION: Patients undergo BMT, from an HLA-haploidentical donor, on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV over 1-2 hours and then tacrolimus orally (PO), once tolerated, on days 4-180, with taper on day 86 in the absence of graft-versus-host disease. Patients also receive mycophenolate mofetil PO three times daily on days 4-35. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 6 months and then annually thereafter.

Conditions

Interventions

TypeNameDescription
DRUGcyclophosphamideGiven IV
DRUGfludarabine phosphateGiven IV
DRUGtacrolimusGiven IV or orally
DRUGmycophenolate mofetilGiven orally
GENETICpolymerase chain reactionCorrelative studies
GENETICfluorescence in situ hybridizationCorrelative studies
GENETICpolymorphism analysisCorrelative studies
GENETICgene expression analysisCorrelative studies
RADIATIONtotal-body irradiationUndergo total-body irradiation
PROCEDUREallogeneic bone marrow transplantationUndergo haploidentical hematopoietic bone marrow transplantation
PROCEDUREallogeneic hematopoietic stem cell transplantationUndergo haploidentical hematopoietic bone marrow transplantation

Timeline

Start date
2002-01-01
Primary completion
2011-03-01
Completion
2014-02-01
First posted
2003-01-27
Last updated
2017-05-17
Results posted
2017-05-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00049504. Inclusion in this directory is not an endorsement.