SGI-110 and Donor Lymphocyte Infusions (DLI) After Allogeneic Stem Cell Transplantation

• Status: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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 relapse without increasing non-relapse mortality translating in an improved disease-free survival.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Francophone des Myelodysplasies
• Treatments: Azacitidine; Guadecitabine

Criteria

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