Clinical trial · Interventional
SGI-110 and Donor Lymphocyte Infusions (DLI) After Allogeneic Stem Cell Transplantation
Guadecitabine SGI-110 and Donor Lymphocyte Infusions (Dli) After Allogeneic Stem Cell Transplantation (Allo Sct) in Very High Risk MDS or AML Patients
NCT03454984CI-TRIAL-00035806unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
High risk MDS (Myelodysplastic Syndrome) patients will be treated with SGI-110 after Allogeneic Stem Cell Transplantation in the hypothesis that SGI-110 maintenance given early after HSCT can prevent relapse without increasing non-relapse mortality translating in an improved disease-free survival.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Guadecitabine | Drug | Guadecitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SGI-110
- description
- * SGI 110 (Guadecitabine) will start on day 40, In case the patient is not eligible yet, he should be assessed again each 30 days until day 130, after what, he is not considered eligible for a preventive treatment by SGI. * Initial dose will be 30/m2/day SQ for 5 days * total 10 cycles of SGI-110
- interventionNames
- Drug: Guadecitabine
Primary outcomes (1)
- measure
- DFS
- timeFrame
- 1 year post transplant
- description
- Disease Free Survival at 1 year post transplant
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- 1 year and 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged from 18 to 70 years * MDS or AML with unfavorable genetics defines as follow: * 4 cytogenetic abnormalities or more or * 3 cytogenetic abnormalities and TP53 or * 3 cytogenetic abnormalities and monosomal karyotype or * Mutations involving EVI1 * Marrow blast \< 20% for and non-proliferative disease * AML patients should have received chemotherapy before transplant * A donor is available (HLA matched or mismatched) * Contraception in women \< 50 years and for men at least the first six months after transplant and 3 months after the last dose of guadecitabine" Exclusion Criteria: * Karnofsky less than 70% * Cancer in 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 a patients with Fanconi anemia or congenital dyskeratosis * Proliferative disease in patients no in remission: WBC\> 15 G/L or use of continuous cytotoxic to maintain WBC \< 15G/L * Proliferative AML: hyperleucocytosis \> 15 G/L, blast count higher than 10% or lower than 10% for less than 6 weeks * No contraception * Pregnant women or breastfeeding women
References
Publications (0)
Data not yet available
No reference posted for this study.