CLOFARABINE/ARA-C TREATMENT COMBINED WITH REDUCED-INTENSITY CONDITIONING ALLOGENEIC STEM CELL TRANSPLANTATION FOR ACUTEMYELOID LEUKEMIA IN PRIMARY TREATMENT FAILURE - SET-RIC
- Conditions
- To improve the 2 year overall survival in patients with acute myeloid leukaemia (AML) in primary treatment failure
- Registration Number
- EUCTR2009-015176-10-FR
- Lead Sponsor
- CHU de Nantes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
-Confirmed diagnosis of AML in the status of primary induction failure (i.e. persistent leu-kemia after 2 courses of induction chemotherapy or persisting bone marrow hypoplasia fol-lowing induction chemotherapy +/-minimal residual disease) OR AML with cytogenetic or hematological relapse within 6 months from documentation of first complete remission.
- Age: 18-65 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.
- Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Documented chloroma
- Documented leukemic infiltration of CNS/cerebrospinal fluid
- Karnofsky performance score below < 60%
- Acute or chronic heart failure
- Severe renal failure (createnine clearance < 50 ml/min)
- Severe liver failure (transaminases or bilirubine > 4x the upper limit of normal)
- HIV infection, chronic viral hepatitis
- Severe neurological or psychiatric disorders
- Any circumstances that provide 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To improve the 2 year overall survival in patients with primary treatment failure;Secondary Objective: Leukemia-free survival (LFS) at 2 years from transplantation<br>- Leukemia response rate at day +30, +90, 6, 12 and 24 months after allo-SCT<br>- Cumulative incidence of relapse, death from leukemia, and non-relapse mortality (NRM)<br>- Incidence and severity of acute and chronic graft-versus-host disease (GVHD)<br>- Feasibility and safety of early discontinuation of immunosuppressive therapy<br>- Feasibility and safety of performing prophylactic donor lymphocytes infusion (pDLI)<br>;Primary end point(s):
- Secondary Outcome Measures
Name Time Method