Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The present trial will establish a prospective sequential Allogeneic Stem Cell Transplantation (allo-SCT) treatment combining both salvage chemotherapy and Reduced Intensity Conditioning (RIC) for primary treatment failure Acute Myeloid Leukemia (AML), to which future innovative strategies can be compared.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Treatments: Clofarabine

Criteria

Inclusion Criteria:

• Confirmed diagnosis of AML in the status of primary induction failure (i.e. persistent leukemia after 2 courses of induction chemotherapy or persisting bone marrow hypoplasia fol-lowing induction chemotherapy +/-minimal residual disease)

• Age: 18-55 years

• Availability of an HLA identical family donor OR unrelated donor with matching in 10/10 alleles (HLA-A, B, C, DRB1, DQB1) or maximum of 1 allele or antigen mismatch OR family donor with maximum 1 allele mismatch.

• Have adequate renal and hepatic functions as indicated by the following laboratory values:

• Serum creatinine ≤1.0 mg/dL; if serum creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m² as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine)-1.154 x (age in years)-0.023 x (0.742 if patient is female)

• Serum bilirubin ≤1.5 mg/dL × upper limit of normal (ULN)

• Aspartate transaminase (AST)/alanine transaminase (ALT) ≤2.5 × ULN

• Alkaline phosphatase ≤2.5 × ULN

Exclusion Criteria:

• Documented chloroma

• Patients having AML M3

• Documented leukemic infiltration of CNS/cerebrospinal fluid

• Karnofsky performance score below < 60%

• Acute or chronic heart failure

• HIV infection, chronic viral hepatitis

• Severe neurological or psychiatric disorders

• Any circumstances that preclude the use of the drugs used within the protocol

• Prior allogeneic or autologous stem cell transplantation

• > 3 courses of prior chemotherapy

• Denied informed consent

• Pregnancy or denied of effective contraceptive method