CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
Cyclophosphamide +7 moredrug
Likely dose
Cyclophosphamide and fludarabine phosphate IV with total-body irradiation, followed by allogeneic bone marrow transplantationAI-extracted
Key inclusion· 8
  • ✓Fanconi anemia with bone marrow failure affecting ≥2 lineages (granulocyte <0.5×10⁹/L, platelet <20×10⁹/L, or hemoglobin <8 g/dL)
  • ✓Fanconi anemia with red blood cell or platelet transfusion requirement due to marrow failure
  • ✓Fanconi anemia with life-threatening bone marrow failure in a single hematopoietic lineage
  • ✓Fanconi anemia with AML or MDS in morphological remission (circulating blasts absent, bone marrow blasts <5%)
Key exclusion· 11
  • ✕Availability of HLA-matched related donor
  • ✕Significant organ dysfunction limiting transplant tolerance: hepatic (active hepatitis, moderate-severe fibrosis/cirrhosis, uncorrectable synthetic dysfunction), pulmonary, or cardiac (ejection fraction <35%, shortening fraction <26%)
  • ✕HIV seropositive
  • ✕AML or MDS in morphological relapse (circulating blasts or bone marrow blasts ≥5%)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00453388
NCT00453388Phase 2Completed
CompareCT.gov

Nonmyeloablative Hematopoietic Cell Transplantation for Patients With Fanconi Anemia Using Alternative Marrow Donors: A Phase II Dose-Finding Study

Fred Hutchinson Cancer Center·interventional·Posted Mar 28, 2007·Updated Jan 29, 2020

In Brief

A Phase 2 clinical trial evaluating Allogeneic Bone Marrow Transplantation, Cyclophosphamide, and 6 other interventions for Acute Myeloid Leukemia in Remission and 3 related conditions. Completed, enrolled 6 participants across 5 sites in 2 countries.

Detailed Summary

This phase II trial studies how well total-body irradiation (TBI) works when given together with fludarabine phosphate and cyclophosphamide followed by donor bone marrow transplant, mycophenolate mofetil, and cyclosporine in treating patients with Fanconi anemia (FA). Giving low doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and TBI before or after a donor bone marrow transplant helps stop the growth of 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 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 mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia in Remission, de Novo Myelodysplastic Syndrome, Fanconi Anemia, Previously Treated Myelodysplastic Syndrome
CountriesBrazil, United States
CollaboratorsNational Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 28, 2007
Enrollment StartFeb 1, 2007
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 19.3 years ago

Interventions

Allogeneic Bone Marrow Transplantationprocedure

Undergo allogeneic bone marrow transplant

Cyclophosphamidedrug

Given IV

Cyclosporinedrug

Given IV or PO

Fludarabine Phosphatedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Mycophenolate Mofetildrug

Given PO

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo allogeneic stem cell transplant

Total-Body Irradiationradiation

Undergo TBI