NCT02757989

Brief Summary

Comparison of survival in patients with or without a matched donor at 36 months

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

37 active sites

Status
completed

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

March 31, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

May 31, 2016

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2024

Completed
Last Updated

August 2, 2024

Status Verified

February 1, 2024

Enrollment Period

8 years

First QC Date

March 31, 2016

Last Update Submit

August 1, 2024

Conditions

MDS

Keywords

Low risk MDSTransplantation

Outcome Measures

Primary Outcomes (1)

  • overall survival

    comparison of overall survival in patients with or without a matched donor (8/8 unrelated donor or matched sibling) at 36 months

    36 months

Secondary Outcomes (7)

  • quality of life

    12, 24 and 36 months

  • number of patients with complete response at 36 month

    36 months

  • number of patients with transformation in AML at 36 month

    36 months

  • proportion of patients with iron overload

    16 months

  • evolution of innovative iron markers including Non-transferrin binding iron (NTBI), labile plasmatic Iron (LPI) and Hepcidine

    3 and 16 months

  • +2 more secondary outcomes

Study Arms (2)

Patients with donor

EXPERIMENTAL

Patients with a matched donor (8/8 at molecular level unrelated donor or matched sibling)

Other: transplantation

Patients without donor

NO INTERVENTION

Patients without a matched donor

Interventions

transplantationOTHER

allogeneic hematopoietic stem cell transplantation in patients with donor

Patients with donor

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed consent
  • Classical IPSS intermediate 1 or low myelodysplastic syndrome associated with at least one poor prognosis feature:
  • Intermediate or higher risk revised IPSS
  • RBC transfusion dependent anemia and failure to 2 or more lines or therapy (including EPO, Lenalidomide or demethylating agent…)
  • thrombocytopenia \< 20 G/L requiring transfusion
  • neutropenia \< 0.5 G/L associated with severe infection (defined as requiring hospitalization)
  • Patient aged ≥ 18 and \< 70 years For young patients, 18-45 years, Fanconi disease and dyskeratosis should be ruled out
  • Patient for whom a transplantation from a matched donor, (8/8 (HLA A, B, C, DRB1) identical at molecular level)unrelated donor or matched sibling), is considered irrespective of donor availability
  • Performance status 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale (At time of screening)
  • Negative pregnancy and adequate contraception (including in male patients wishing to father), if relevant.
  • Wash-out of at least 30 days since a previous treatment with Vidaza, Lenalidomide, EPO or any other treatment inducing cytopenias.

You may not qualify if:

  • MDS classified according to classical IPSS as intermediate 2 or High risk
  • Transformation in Acute myeloid Leukemia (AML)
  • Severe active infection or any other uncontrolled severe condition.
  • Organ dysfunctions including the following
  • Hepatic : total bilirubin \> 2 times upper limit of normal (ULN) (except moderate unconjugated hyperbilirubinemia due to intra medullary hemolysis or Gilbert syndrome) , alanine transaminase (ALT) and aspartate transaminase (AST) \> 3xULN
  • Symptomatic respiratory chronic failure
  • Symptomatic cardiac failure
  • Renal clearance \< 60ml/min
  • Prior malignancy (except in situ cervix carcinoma, limited basal cell carcinoma, or other tumors if not active during the last 3 years)
  • MDS with the following causal germline disease : Fanconi anemia, GATA2 related syndromes and telomere disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

CHU d'Amiens

Amiens, 80054, France

Location

CHU d'Angers

Angers, 49933, France

Location

Centre hospitalier Victor Dupouy

Argenteuil, 95100, France

Location

CHU Jean Minjoz

Besançon, 25030, France

Location

Hôpital Avicenne

Bobigny, 93009, France

Location

CHU de Haut Lévèque

Bordeaux, 33604, France

Location

CHRU Côte de Nacre

Caen, 14033, France

Location

CHU Estaing

Clermont-Ferrand, 63000, France

Location

CHSF Gilles de Corbeil

Corbeil-Essonnes, 91106, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

CH Le Mans

Le Mans, 72037, France

Location

Hôpital Saint Vincent de Paul

Lille, 59020, France

Location

Hôpital Huriez

Lille, 59037, France

Location

Hôpital Dupuytren

Limoges, 87042, France

Location

Centre hospitalier Lyon Sud

Lyon, 69495, France

Location

GHEF, site de Meaux

Meaux, 77100, France

Location

CHRU de Montpellier

Montpellier, 34295, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CHU de Nice

Nice, 06202, France

Location

CHU de Nîmes

Nîmes, 30029, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

Hôpital Pitié Salpétrière

Paris, 75013, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Necker

Paris, 75015, France

Location

CH Joffre

Perpignan, 66046, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

CH René Dubos

Pontoise, 95300, France

Location

CHU de Reims

Reims, 51092, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Institut Curie

Saint-Cloud, 92210, France

Location

Institut de cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42271, France

Location

Hôpital civil

Strasbourg, 67091, France

Location

IUCT-Oncopole

Toulouse, 31059, France

Location

Hôpital Bretonneau

Tours, 37000, France

Location

Hôpital de Brabois

Vandœuvre-lès-Nancy, 54550, France

Location

Related Publications (2)

  • Sebert M, Thepot S, Cluzeau T, Duployez N, Lefebvre T, Chaffaut C, Orvain C, Loschi M, Peterlin P, Chevallier P, D'Aveni M, Rubio MT, Rauzy O, Huynh A, Charbonnier A, Sapena R, Chermat F, Ceballos P, Fossard G, Nguyen S, Park S, Ades L, Peffault de Latour R, Preudhomme C, Fenaux P, Chevret S, Robin M. Transplantation in patients with lower-risk MDS: a prospective phase 2 trial based on donor availability. Blood Adv. 2026 Jan 27;10(2):494-504. doi: 10.1182/bloodadvances.2025017035.

    PMID: 41061188DERIVED

  • Robin M, Fenaux P. Which lower risk myelodysplastic syndromes should be treated with allogeneic hematopoietic stem cell transplantation? Leukemia. 2020 Oct;34(10):2552-2560. doi: 10.1038/s41375-020-0967-x. Epub 2020 Jul 13.

    PMID: 32661295DERIVED

MeSH Terms

Interventions

Transplantation

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Marie Robin, MD

    Saint-Louis Hospital, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2016

First Posted

May 2, 2016

Study Start

May 31, 2016

Primary Completion

June 7, 2024

Study Completion

June 7, 2024

Last Updated

August 2, 2024

Record last verified: 2024-02

Locations

FR(37)