Status:
COMPLETED
Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure
Lead Sponsor:
Nantes University Hospital
Conditions:
AML
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 pri...
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 * Leukem...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01188174
Start Date
July 1 2010
End Date
December 1 2014
Last Update
December 5 2014
Active Locations (9)
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1
CHU de Bordeaux
Bordeaux, France
2
CHU Caen
Caen, France
3
CHRU lille
Lille, France
4
Hôpital Edouard Herriot
Lyon, France