NCT03454984

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2018

Typical duration for phase_2

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

November 15, 2018

Status Verified

February 1, 2018

Enrollment Period

1.8 years

First QC Date

February 20, 2018

Last Update Submit

November 13, 2018

Conditions

Myelodysplastic SyndromesAcute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • DFS

    Disease Free Survival at 1 year post transplant

    1 year post transplant

Secondary Outcomes (1)

  • Overall survival

    1 year and 2 years

Study Arms (1)

SGI-110

EXPERIMENTAL

* 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

Drug: Guadecitabine

Interventions

GuadecitabineDRUG

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

Also known as: SGI-110
SGI-110

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged from 18 to 70 years
  • MDS or AML with unfavorable genetics defines as follow:
  • cytogenetic abnormalities or more or
  • cytogenetic abnormalities and TP53 or
  • 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"

You may not qualify if:

  • Karnofsky less than 70%
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

CHU d'Angers

Angers, 49933, France

Location

CHU Estaing

Clermont-Ferrand, 63000, France

Location

Hôpital St Vincent de Paul

Lille, 59020, France

Location

CHU Nantes

Nantes, 44093, France

Location

Hôpital Archet 1

Nice, 06200, France

Location

Hôpital St Louis

Paris, 75010, France

Location

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Hôpital Necker

Paris, 75743, France

Location

CHU de Haut-Lévèque

Pessac, 33604, France

Location

Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

CHU Toulouse - IUCT Oncopole

Toulouse, 31059, France

Location

CHU Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Myelodysplastic SyndromesLeukemia, Myeloid, Acute

Interventions

guadecitabine

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Marie Robin, MD

    Hôpital Saint Louis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatiha Chermat

CONTACT

33171207059fatiha.chermat-ext@aphp.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: all patients eligible to receive SGI-110 at day 40 to day130 after transplantation, will be treated
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2018

First Posted

March 6, 2018

Study Start

November 1, 2018

Primary Completion

September 1, 2020

Study Completion

March 1, 2022

Last Updated

November 15, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(12)