Clinical Trials Directory

Trials / Completed

CompletedNCT00856388

Fludarabine Phosphate, Melphalan, Total-Body Irradiation, Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer or Bone Marrow Failure Disorders

A Pilot Trial Of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan, And Low Dose Total Body Irradiation

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
62 (actual)
Sponsor
Roswell Park Cancer Institute · Academic / Other
Sex
All
Age
3 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This clinical trial is studying how well giving fludarabine phosphate and melphalan together with total-body irradiation followed by donor stem cell transplant works in treating patients with hematologic cancer or bone marrow failure disorders. Giving low doses of chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells or abnormal cells. It may also stop 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 or abnormal cells (graft-versus-tumor effect)

Detailed description

PRIMARY OBJECTIVES: I. To determine the transplant related mortality (TRM) of this reduced intensity transplantation (RIT) combination in a patient population that is usually not eligible for a full myeloablative allogeneic transplant. SECONDARY OBJECTIVES: I. To evaluate engraftment, safety, clinical response, evidence of graft-versus-malignancy effect/graft-versus-host disease (GVHD) and overall outcomes of treatment with our RIT regimen across a variety of hematological conditions. OUTLINE: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -5 to -2 and melphalan\* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0. Note: \*Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan. After completion of study treatment, patients are followed up periodically.

Conditions

Interventions

TypeNameDescription
DRUGfludarabine phosphateGiven IV
DRUGmelphalanGiven IV
RADIATIONtotal-body irradiationUndergo total-body irradiation
PROCEDUREallogeneic hematopoietic stem cell transplantationUndergo allogeneic stem cell transplantation
BIOLOGICALanti-thymocyte globulinGiven IV

Timeline

Start date
2009-01-14
Primary completion
2012-08-09
Completion
2019-03-13
First posted
2009-03-05
Last updated
2019-11-13
Results posted
2016-06-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00856388. Inclusion in this directory is not an endorsement.