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

NCT03454984 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-11-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Guadecitabine

30/m2/day SubCutaneous for 5 days (Cycle = 28 days). total of 10 cycles

Sponsors & Collaborators

  • Groupe Francophone des Myelodysplasies

    lead OTHER

Principal Investigators

  • Marie Robin, MD · Hôpital Saint Louis

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2020-09-30
Completion
2022-03-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03454984 on ClinicalTrials.gov