Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00005898
NCT00005898CompletedPhase 1

Phase I/II Study of Total Body Irradiation, Cyclophosphamide, and Fludarabine Followed by Alternate Donor Hematopoietic Cell Transplantation in Patients With Fanconi's Anemia

University of Minnesota2 sites in 1 country30 target enrollmentStarted: February 2000Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
30
Locations
2
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

OBJECTIVES: I. Determine the probability of engraftment with total body irradiation, cyclophosphamide, fludarabine, and anti-thymocyte globulin followed by HLA nongenotypically identical donor, T-cell depleted hematopoietic cell transplantation in patients with Fanconi's anemia.

II. Determine the incidence of acute and chronic graft-versus-host disease in these patients after undergoing this treatment regimen.

III. Determine the one-year survival rate in these patients after undergoing this treatment regimen.

IV. Determine the toxicity of this treatment regimen in these patients. V. Determine the incidence of relapse in patients with myelodysplastic syndrome or acute myeloid leukemia after undergoing this treatment regimen.

Detailed Description

PROTOCOL OUTLINE: Donor bone marrow, peripheral blood, or umbilical cord blood is processed to harvest CD34+ cells.

Patients receive preparative cytoreductive therapy comprising total body irradiation on day -6; cyclophosphamide IV over 2 hours on days -5 to -2; fludarabine IV over 30 minutes on days -5 to -2; methylprednisone IV on days -5 to 24; anti-thymocyte globulin IV over 4-6 hours on days -5 to -1; cyclosporine IV over 2 hours every 12 hours (every 8 hours for patients less than 40 kg in weight) on days -3 to 180, and then tapering in the absence of graft-versus-host disease; hematopoietic cell transplantation on day 0; and filgrastim (G-CSF) IV starting on day 1 and continuing until blood counts recover.

Patients are followed at days 60, 90, and 180, and then annually for 3 years.

Study Design

Study Type
Interventional
Primary Purpose
Treatment

Eligibility Criteria

Ages
0 Years to 34 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Other

Study Sites (2)

Loading locations...

Similar Trials

Completed
Phase 1
Phase I Pilot Study of Total-Body Irradiation, Anti-Thymocyte Globulin and Cyclophosphamide Followed By Syngeneic or Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple SclerosisMultiple Sclerosis
NCT00014755Fred Hutchinson Cancer Center35
Completed
Phase 2
Total-Body Irradiation and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer and Other DiseasesMyelodysplastic SyndromesLymphomaLeukemia
NCT00317785Fred Hutchinson Cancer Center50
Recruiting
Not Applicable
Total body irradiation, cyclophosphamide and imported Tiotepa for conditioning chemotherapy of pediatric refractory malignancypediatric with refractory malignancy
JPRN-UMIN000004969YOKOHAMA CITY UNIVERSITY SCHOOL OF MEDICINE5
Active, not recruiting
Phase 1
TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic SclerosisSystemic Scleroderma
NCT04380831City of Hope Medical Center15
Terminated
Phase 2
Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood CancerAccelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveAcute Leukemia in RemissionAcute Myeloid Leukemia With FLT3/ITD MutationAcute Myeloid Leukemia With Gene MutationsB-Cell Non-Hodgkin LymphomaCD40 Ligand DeficiencyChronic Leukemia in RemissionAcute Myeloid LeukemiaAcute Lymphoblastic LeukemiaChronic Granulomatous DiseaseChronic Myelogenous Leukemia, BCR-ABL1 PositiveChronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveCongenital Amegakaryocytic ThrombocytopeniaCongenital NeutropeniaCongenital Pure Red Cell AplasiaChronic Lymphocytic LeukemiaGlanzmann ThrombastheniaImmunodeficiency SyndromeMyeloproliferative NeoplasmParoxysmal Nocturnal HemoglobinuriaMyelodysplastic SyndromePlasma Cell MyelomaRecurrent Non-Hodgkin LymphomaRefractory Non-Hodgkin LymphomaSecondary Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromeShwachman-Diamond SyndromeSickle Cell DiseaseT-Cell Non-Hodgkin LymphomaWaldenstrom MacroglobulinemiaWiskott-Aldrich SyndromeMyelofibrosisChronic Myelomonocytic LeukemiaAplastic AnemiaPolycythemia VeraThalassemiaSevere Aplastic Anemia
NCT03333486Roswell Park Cancer Institute31