CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Cyclophosphamide +2 moredrug
Likely dose
Cyclophosphamide 10 mg/kg/day × 4 days; Fludarabine 30 mg/m² × 5 days; Total body irradiation 450 cGY in a single fractionAI-extracted
Key inclusion· 8
  • ✓Diagnosis of Fanconi anemia confirmed by mitomycin or diepoxybutane (DEB) chromosomal breakage testing
  • ✓One of three hematologic diagnoses: severe aplastic anemia (SAA)/severe isolated single lineage cytopenia, myelodysplastic syndrome (MDS), or acute leukemia
  • ✓Access to HLA-compatible unrelated donor (matched at all A, B, DRB1 loci or mismatched at 1/6 loci), OR HLA-mismatched related donor who is HLA-haplotype identical with normal DEB test, OR cord blood unit matched or mismatched at 1-2/6 loci
  • ✓Karnofsky (adults) or Lansky (pediatric) performance scale >70%
Key exclusion· 4
  • ✕Active CNS leukemic involvement
  • ✕Pregnancy or breast-feeding
  • ✕Active viral, bacterial, or fungal infection
  • ✕Seropositive for HIV-I/II or HTLV-I/II

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

Search/NCT00595127
NCT00595127N/ACompleted
CompareCT.gov

A Pilot Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using Total Body Irradiation, Cyclophosphamide and Fludarabine

Memorial Sloan Kettering Cancer Center·interventional·Posted Jan 16, 2008·Updated Aug 10, 2016

In Brief

A clinical study evaluating Cyclophosphamide, Fludarabine, and 1 other intervention for Fanconi Anemia. Completed, enrolled 21 participants across 1 site.

Detailed Summary

The purpose of this research study is to: (1) determine if the combination of low dose total body irradiation, low dose cyclophosphamide and the addition of fludarabine, and a serum to suppress the immune system can allow selected stem cells to take and grow; (2) determine if selected stem cells from the blood or marrow can take and not cause graft-versus-host disease (GvHD), and; (3) evaluate the side effects of the combination of low dose radiation and chemotherapy drugs used for these transplants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFanconi Anemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Miltenyi Biotec, Inc.

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 16, 2008
Enrollment StartJun 1, 2001
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11.9 yearsPosted 18.5 years ago

Interventions

Cyclophosphamidedrug

Cyclophosphamide (10mg/kg/day x 4days)

Fludarabinedrug

Fludarabine (30mg/m\^2/day x 5 days)

Total body irradiation (TBI)radiation

TBI (450 cGY in a single fraction)