CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
anti-thymocyte globulin +6 morebiological
Likely dose
Busulfan 0.8 mg/kg IV every 12 hours on Days -7 and -6 (1.0 mg/kg IV if <4 years old); Cyclophosphamide 10 mg/kg IV on Days -5 through -2; Fludarabine phosphate 35 mg/m² IV on Days -5 through -2; Anti-thymocyte globulin 15 mg/kg/day IV every 12 hours on Days -5 through -1AI-extracted
Key inclusion· 7
  • ✓Age <45 years with diagnosed Fanconi anemia
  • ✓Biallelic BRCA2 mutations, or aplastic anemia, or advanced MDS (≥5% blasts), or acute leukemia ineligible for total body irradiation
  • ✓Aplastic anemia defined as platelet count <20×10⁹, ANC <5×10⁸/L, or Hgb <8 g/dL
  • ✓HLA-A, B, DRB1 identical or 1 antigen mismatched related/unrelated bone marrow donor, or HLA-A, B, DRB1 identical, 1 or 2 antigen mismatched related/unrelated umbilical cord blood donor
Key exclusion· 3
  • ✕Active CNS leukemia at time of HSCT
  • ✕Active uncontrolled infection within one week of HSCT
  • ✕Pregnant or lactating female

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

Search/NCT00258427
NCT00258427Phase 2Completed
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Hematopoietic Stem Cell Transplantation in High Risk Patients With Fanconi Anemia MT2002-02

Masonic Cancer Center, University of Minnesota·interventional·Posted Nov 24, 2005·Updated Dec 2, 2021

In Brief

A Phase 2 clinical trial evaluating anti-thymocyte globulin, filgrastim, and 5 other interventions for Fanconi Anemia. Completed, enrolled 14 participants across 1 site.

Detailed Summary

RATIONALE: A bone marrow or umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Giving combination chemotherapy before a donor stem cell transplant may make the transplant more likely to work. This may be an effective treatment for patients with high risk Fanconi's anemia. PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating high risk patients who are undergoing a donor stem cell transplant for Fanconi's anemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFanconi Anemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 24, 2005
Enrollment StartMar 26, 2002
Primary CompletionOct 10, 2020
TodayJul 2, 2026
Enrollment to primary: 18.5 yearsPosted 20.6 years ago

Interventions

anti-thymocyte globulinbiological

Given 15 mg/kg/day intravenously every 12 hours on Days -5 through -1.

filgrastimbiological

given 5 mcg/kg/day intravenously on Day 1 (continue until absolute neutrophil count (ANC) ≥2.5 x 10\^9/L)

busulfandrug

Busulfan 0.8 mg/kg intravenously (IV) every 12 hours on Days -7 and -6 (1.0 mg/kg IV if \<4 years old)

cyclophosphamidedrug

10 mg/kg intravenously (IV) on Days -5 through -2.

fludarabine phosphatedrug

35 mg/m\^2 intravenously (IV) on Days -5 through -2.

methylprednisolonedrug

1 mg/kg intravenously (IV) every 12 hours on Days -5 through -1.

Hematopoietic stem cell transplantationbiological

Infused on Day 0 - Donor bone marrow or umbilical cord blood will be collected in the usual sterile manner using established parameters determined by the National Marrow Donor Program.