Clinical Trials Directory

Trials / Completed

CompletedNCT00397813

Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders

Low-Dose TBI Dose Escalation to Decrease Risks of Progression and Graft Rejection After Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning as Treatment for Untreated Myelodysplastic Syndrome or Myeloproliferative Disorders - A Multi-Center Trial

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
77 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
50 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies the side effects and best dose of total-body irradiation when given together with fludarabine phosphate followed by a donor peripheral stem cell transplant in treating patients with myelodysplastic syndromes (MDS) or myeloproliferative disorders (MPD). Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. Giving chemotherapy or radiation therapy before or after transplant also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune 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 cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

Detailed description

PRIMARY OBJECTIVES: I. Decrease the incidence of day-200 hematopoietic cell transplantation (HCT) failure to \< 20% in patients with MDS-Refractory anemia (RA)-(ringed sideroblasts \[RS\])/MPD and in patients with chronic myelomonocytic leukemia (CMML)/refractory anemia with excess blasts (RAEB). SECONDARY OBJECTIVES: I. The rate of relapse/progression in patients with MPD or MDS-RA and those with CMML or MDS-RAEB. II. The probability of progression free survival (PFS) in patients with MPD or MDS-RA and those with CMML or MDS-RAEB. III. The kinetics of donor engraftment. IV. The incidence of infections. OUTLINE: This is a dose-escalation study of total body irradiation (TBI). NONMYELOABLATIVE CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to -2 and undergo TBI on day 0. PERIPHERAL BLOOD STEM CELL (PBSC) TRANSPLANTATION: Patients undergo filgrastim (G-CSF)-mobilized PBSC infusion after TBI on day 0. IMMUNOSUPPRESSION: Matched Related Donor: Patients receive cyclosporine orally (PO) twice daily (BID) on days -3 to 56, followed by a taper until day 180. Patients also receive mycophenolate mofetil (MMF) PO BID beginning 4-6 hours after transplantation on day 0 and continue until day 27. Unrelated Donor: Patients receive cyclosporine PO BID on days -3 to 100, followed by a taper until day 180. Patients also receive MMF PO three times daily beginning 4-6 hours after transplantation on day 0 and continue until day 40, followed by a taper until day 96. After completion of study treatment, patients are followed periodically.

Conditions

Interventions

TypeNameDescription
DRUGCyclosporineGiven PO
DRUGFludarabine PhosphateGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGMycophenolate MofetilGiven PO
PROCEDURENonmyeloablative Allogeneic Hematopoietic Stem Cell TransplantationUndergo transplantation
PROCEDUREPeripheral Blood Stem Cell TransplantationUndergo PBSC transplant
RADIATIONTotal-Body IrradiationUndergo TBI

Timeline

Start date
2006-01-01
Primary completion
2017-09-01
Completion
2018-03-01
First posted
2006-11-10
Last updated
2020-01-31
Results posted
2018-10-24

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00397813. Inclusion in this directory is not an endorsement.