Status:
UNKNOWN
SGI-110 and Donor Lymphocyte Infusions (DLI) After Allogeneic Stem Cell Transplantation
Lead Sponsor:
Groupe Francophone des Myelodysplasies
Conditions:
Myelodysplastic Syndromes
Acute Myeloid Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Allogeneic stem cell transplant (HSCT) is the only curative treatment in patients with intermediate-2 and high risk patients (according to classical IPSS) but approximately 30% of patients relapse and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03454984
Start Date
November 1 2018
End Date
March 1 2022
Last Update
November 15 2018
Active Locations (12)
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1
CHU d'Angers
Angers, France, 49933
2
CHU Estaing
Clermont-Ferrand, France, 63000
3
Hôpital St Vincent de Paul
Lille, France, 59020
4
CHU Nantes
Nantes, France, 44093