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drugset / Trial / NCT04002115

Clofarabine Pre-conditioning Followed by Stem Cell Transplant for Non-remission AML

NCT04002115 ↗

Phase 2 Terminated 2 enrolled Milton S. Hershey Medical Center
NaSequentialOpen-labelTreatment

Summary

The Investigators would like to study the incidence of complete remission (CR) at day +30 after Clofarabine followed by haploidentical transplant. The conditioning regimen used is Fludarabine, Busulfan (2 doses) or cyclophosphamide (2 doses) and Total Body Irradiation (TBI) with post transplant cyclophosphamide for patients with Acute Myeloid Leukemia (AML) who are not in remission prior to considering allogeneic transplant with haploidentical donors.

Timeline

Start
2020-06-03
Primary completion
2022-08-30
Completion
2022-11-07

Outcome

Outcome not reported

Stopped (Enrollment): “terminated due to low accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Clofarabine Other / unclassified 20 mg/m2 —
Subject Clofarabine Other / unclassified 30 mg/m2 —
Background Busulfan Small molecule 3.2 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified 14.5 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified 50 mg/kg Intravenous
Background Fludarabine Small molecule 24 mg/m2 Intravenous
Background Fludarabine Small molecule 40 mg/m2 Intravenous
Background Granulocyte colony-stimulating factor Protein / enzyme biologic — —
Background Mycophenolate Mofetil Small molecule — —
Background Tacrolimus Small molecule — —

Indications

acute myeloid leukemia