AzTrials
AzTrials

MDSNCT02757989

Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome Low Risk

A study testing transplantation in people with MDS, run by Groupe Francophone des Myelodysplasies at 37 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Comparison of survival in patients with or without a matched donor at 36 months Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
MDS
What is being tested?
transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
37 sitesFrance
Study dates
31 May 2016to 7 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 11Show fewer
  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

France37 sites

  • CHU d'Amiens

    Amiens, 80054

  • CHU d'Angers

    Angers, 49933

  • Centre hospitalier Victor Dupouy

    Argenteuil, 95100

  • CHU Jean Minjoz

    Besançon, 25030

  • Hôpital Avicenne

    Bobigny, 93009

  • CHU de Haut Lévèque

    Bordeaux, 33604

  • CHRU Côte de Nacre

    Caen, 14033

  • CHU Estaing

    Clermont-Ferrand, 63000

  • CHSF Gilles de Corbeil

    Corbeil-Essonnes, 91106

  • Hôpital Henri Mondor

    Créteil, 94010

  • CHU de Grenoble

    Grenoble, 38043

  • CH Le Mans

    Le Mans, 72037

  • Hôpital Saint Vincent de Paul

    Lille, 59020

  • Hôpital Huriez

    Lille, 59037

  • Hôpital Dupuytren

    Limoges, 87042

  • Centre hospitalier Lyon Sud

    Lyon, 69495

  • GHEF, site de Meaux

    Meaux, 77100

  • CHRU de Montpellier

    Montpellier, 34295

  • CHU de Nantes

    Nantes, 44093

  • CHU de Nice

    Nice, 06202

  • CHU de Nîmes

    Nîmes, 30029

  • Hôpital Saint Louis

    Paris, 75010

  • Hôpital Pitié Salpétrière

    Paris, 75013

  • Hôpital Cochin

    Paris, 75014

  • Hôpital Necker

    Paris, 75015

  • CH Joffre

    Perpignan, 66046

  • CHU de Poitiers

    Poitiers, 86021

  • CH René Dubos

    Pontoise, 95300

  • CHU de Reims

    Reims, 51092

  • Hôpital Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • Institut Curie

    Saint-Cloud, 92210

  • Institut de cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42271

  • Hôpital civil

    Strasbourg, 67091

  • IUCT-Oncopole

    Toulouse, 31059

  • Hôpital Bretonneau

    Tours, 37000

  • Hôpital de Brabois

    Vandœuvre-lès-Nancy, 54550

Other trials in France

About this study

Official title: Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Low or Intermediate-1 Myelodysplastic Syndrome: A Prospective Multicenter Phase II Study Based on Donor Availability on Behalf of the GFM & SFGM-TC

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

Read the detailed description

Patients with a matched donor (8/8 at molecular level unrelated donor or matched sibling) received an allogeneic hematopoietic stem cell transplantation.

Patients without a matched donor received the best available treatment. All patients will be followed at least 36 months or until the end of the study.

Conditions
MDS
Being tested
transplantation
Keywords
Low risk MDS, Transplantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transplantationOther

    allogeneic hematopoietic stem cell transplantation in patients with donor

Study groups in NCT02757989
Study groupRoleWhat they receive
Patients with donorExperimentalPatients with a matched donor (8/8 at molecular level unrelated donor or matched sibling)
Receives: Other: transplantation
Patients without donorNo interventionPatients without a matched donor

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 36 months

Secondary outcomes (7)

  1. quality of life

    comparison of quality of life in patients with or without a matched donor, quality of life assessed by questionnaire (EORTC version 3) at inclusion, 12, 24 and 36 months

    Measured: 12, 24 and 36 months

  2. number of patients with complete response at 36 month

    comparison between patients with or without a donor for cumulative incidence of complete response at 36 month

    Measured: 36 months

  3. number of patients with transformation in AML at 36 month

    comparison between patients with or without a donor for cumulative incidence of transformation in AML at 36 month

    Measured: 36 months

  4. proportion of patients with iron overload

    proportion of patients with iron overload (Serum Ferritin (SF)>1000 ng/mL or Red Blood Cells transfusion>20) at time of inclusion and at 16 month after inclusion for non-transplanted patients and 12 months post-transplant for transplanted patients

    Measured: 16 months

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

    evolution of innovative iron markers including Non-transferrin binding iron (NTBI), labile plasmatic Iron (LPI) and Hepcidine measured at time of inclusion, at 3 month and 16 month post-inclusion for all patients; In transplanted patients these markers will be measured just before conditioning regimen (J-5), Just before the transplantation (J0), at D7, 30, 100 and 12 month after transplant.

    Measured: 3 and 16 months

  6. efficiency of chelation

    the effect of chelation will be assessed at 3 month after inclusion for all patient and post transplant by measuring Serum ferritin level

    Measured: 3 and 16 months

  7. number of patients with adverse events grade III and IV as assessed by CTCAE v4.0

    comparison between patients with or without a donor for number of Grade III and IV toxicities (hematological and non-hematological) recorded according to NCI CTCAE criteria versions 4.0 during the 36 months

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2016 (estimated)
  2. Study start31 May 2016
  3. Primary completion7 Jun 2024
  4. Study completion7 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02757989
Sponsor's protocol ID
MDS-ALLO-RISK
Other IDs
2015-A00292-47
Status last verified
Feb 2024
First submitted
31 Mar 2016
Last updated
2 Aug 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 41061188

  • 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.

    PubMed 32661295

Questions about this trial

What is this clinical trial studying?

A study testing transplantation in people with MDS, run by Groupe Francophone des Myelodysplasies at 37 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02757989, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in