EUCTR2009-015176-10-FR
Active, not recruiting
Not Applicable
CLOFARABINE/ARA-C TREATMENT COMBINED WITH REDUCED-INTENSITY CONDITIONING ALLOGENEIC STEM CELL TRANSPLANTATION FOR ACUTEMYELOID LEUKEMIA IN PRIMARY TREATMENT FAILURE - SET-RIC
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- To improve the 2 year overall survival in patients with acute myeloid leukaemia (AML) in primary treatment failure
- Sponsor
- CHU de Nantes
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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