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

Phase 2

Completed

• Conditions: AML
• Interventions: Drug: Clofarabine

• Registration Number: NCT01188174
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-24
• Study First Posted: 2010-08-25
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clofarabine	Clofarabine	-

Primary Outcome Measures

Name	Time	Method
Evaluation of the survival rate at 2 years after transplantation	at 2 years after transplantation

Trial Locations

Locations (9)

Nantes University hospital; 🇫🇷 Nantes, France

CHU Caen; 🇫🇷 Caen, France

CHRU lille; 🇫🇷 Lille, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Institut Paoli Calmette; 🇫🇷 Marseille, France

CHU Toulouse; 🇫🇷 Toulouse, France

Paris saint Louis; 🇫🇷 Paris, France

CHRU de Strasbourg; 🇫🇷 Strasbourg, France