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

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 2

Conditions: AML

Treatments: Drug: Clofarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01188174

BRD 09/6-C

Details and patient eligibility

About

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.

Full description

Primary Endpoint: To improve the 2 year overall survival in patients with primary treatment failure

* Secondary Endpoints:

• Feasibility of early transplantation within a multicenter trial
• Leukemia-free survival (LFS) at 2 years from transplantation
• Leukemia Response rate at day +30, +90 and 6 months
• Cumulative incidence of relapse, death from leukemia, and non-relapse mortality (NRM)
• Incidence and severity of acute and chronic Graft-versus-Host disease
• Feasibility and safety of early discontinuation of immunosuppressive therapy

Enrollment: 26 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Clofarabine

Experimental group

Treatment:

Drug: Clofarabine