Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT02017457
Eligibility Criteria:
Inclusion Criteria:
1. Patients:
* Age ≥ 18 years
* Be able to understand and sign informed consent
* Fertile patients must use a reliable contraception method
2. Disease status at transplantation:
* AML in first or subsequent complete remission (\< 5% marrow blasts)
* MDS with less than 10% marrow blasts at the time of transplantation
3. Transplantation:
* Allogeneic transplantation using a sibling or unrelated donor with matching in 10/10 alleles (HLA-A, B, C, DRB1, DQB1) or maximum of one allele or one antigen or 1 antigen + 1 allele or 1 antigen + 1 DQB1 antigen or 2 alleles mismatches.
* Myeloablative or reduced-intensity conditioning
* Second transplantation is allowed
* Donor is willing to donate lymphocytes
4. Clinical situation:
* Cytological relapse after allo-SCT defined as the recurrence of more than 5% blasts on bone marrow aspiration (AML) or evidence of MDS
* Immunophenotypic relapse defined as the recurrence of an abnormal phenotype on flow cytometry in bone marrow aspirate (only in case of a specific phenotype).
* Cytogenetic or molecular relapse defined as the persistence or recurrence of a cytogenetic abnormality or molecular marker in bone marrow aspiration or peripheral blood. WT1 expression is not considered as reliable marker for relapse in this protocol but FLT3-ITD, NPM1, CEBPA, or translocation-specific markers (such as MLL-PTD, AML-ETO, CBFB-MYH11) are.
5. Immunosuppressive therapy should have been stopped before inclusion.
Exclusion Criteria:
* More than 30% marrow blasts at the time of inclusion
* Extramedullary relapse including CNS involvement
* ECOG Performance status \> 2
* Active acute grade II-IV GvHD at the time of inclusion
* Active chronic GvHD requiring systemic therapy at the time of inclusion
* Uncontrolled infection
* HIV positive
* Acute or chronic heart failure (NYHA class III or IV) or symptomatic ischemic heart disease or ejection fraction \< 35% or uncontrolled arrhythmia
* Severe liver failure (total bilirubin \> 3 mg/dL, SGPT \> 4 X upper normal limit)
* Severe pulmonary failure (corrected DLCo \< 35%)
* Terminal renal failure requiring dialysis
* Severe neurological or psychiatric disorders
* Concurrent investigational drug.
* Other treatment for relapse, except for hydroxyurea but it should be stopped before inclusion in the study.
* Female who is pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02017457
Study Brief:
Protocol Section:
NCT02017457