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ASTX727 AND DONOR LYMPHOCYTE INFUSIONS AFTER ALLOGENEIC STEM CELL TRANSPLANTATION IN VERY HIGH RISK MDS OR AML PATIENTS
EU CTIS ID: 2024-515353-24-00
What this study is testing
Achieving a disease-free survival of 35% (expected 12%), 12 months after transplant
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged from 18 to 70 years
- MDS, CMML or AML should have at least one of those criteria: 1) For MDS: Revised IPSS poor or very poor ; For AML: ELN adverse risk ; 2) Unfavorable genetics defined as follow: 4 or more cytogenetic abnormalities or 3 cytogenetic abnormalities and TP53 or other unfavorable mutations (ASXL1, RUNX1) or 3 cytogenetic abnormalities and monosomal karyotype or mutations involving EVI1 ; 3) AML post MDS or MPN, or AML relapsing less than 2 years after first CR
- AML patients should have received chemotherapy
- Marrow blast < 20% for MDS and < 10% for AML post chemotherapy before HSCT
- Non-proliferative disease
- A donor is available (HLA matched or mismatched)
You likely can't join if
- ECOG 3 or more
- No contraception
- Pregnant or breastfeeding women
- Cancer less than 2 years before inclusion or cancer not in remission the last 2 years before inclusion (except in situ cancer or baso cellular cancer)
- Cardiac failure with EF < 50%
- Creatininemia level > 150 µmol/L
See the full eligibility criteria
- Patients aged from 18 to 70 years
- MDS, CMML or AML should have at least one of those criteria: 1) For MDS: Revised IPSS poor or very poor ; For AML: ELN adverse risk ; 2) Unfavorable genetics defined as follow: 4 or more cytogenetic abnormalities or 3 cytogenetic abnormalities and TP53 or other unfavorable mutations (ASXL1, RUNX1) or 3 cytogenetic abnormalities and monosomal karyotype or mutations involving EVI1 ; 3) AML post MDS or MPN, or AML relapsing less than 2 years after first CR
- AML patients should have received chemotherapy
- Marrow blast < 20% for MDS and < 10% for AML post chemotherapy before HSCT
- Non-proliferative disease
- A donor is available (HLA matched or mismatched)
- Adequate contraception in women < 50 years and for men. Subjects must agree to use, and to be able to comply with, effective contraception without interruption, at least the first six months after transplant, throughout the entire duration of study drug therapy and for 3 months after the last dose of study drug therapy.
- ECOG 3 or more
- No contraception
- Pregnant or breastfeeding women
- Cancer less than 2 years before inclusion or cancer not in remission the last 2 years before inclusion (except in situ cancer or baso cellular cancer)
- Cardiac failure with EF < 50%
- Creatininemia level > 150 µmol/L
- Liver enzyme > 3 N
- Conjugated bilirubinemia > 25 µmol/L
- MDS occurring in patients with Fanconi anemia or congenital dyskeratosis
- Proliferative disease in patients not in remission: WBC > 15 G/L or use of continuous cytotoxic to maintain WBC < 15 G/L
- AML with marrow or peripheral blast count higher than 10% after chemotherapy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.