NCT03223961

Brief Summary

This is an open-label, randomized, multicenter, phase III study Patients with baseline Hb comprised between 9 and 10.5g/dl will be randomized to receive EPO Alfa 60000 UI/week for at least 12 weeks:

  • Either at diagnosis Or
  • at the Hb threshold chosen for RBC transfusions (must be \< 9g/dl)

Trial Health

75
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P25-P50 for phase_3

Timeline
29mo left

Started Mar 2018

Longer than P75 for phase_3

Geographic Reach
1 country

39 active sites

Status
active not recruiting

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

Study Progress77%
Mar 2018Oct 2028

First Submitted

Initial submission to the registry

July 11, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

March 26, 2018

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Expected
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

5.5 years

First QC Date

July 11, 2017

Last Update Submit

March 6, 2025

Conditions

Myelodysplastic Syndromes

Keywords

myelodysplastic syndromeerythropoetin

Outcome Measures

Primary Outcomes (1)

  • Time to RBC transfusion dependence in non RBC transfusion dependent lower risk MDS patients with anemia with early (at inclusion of the patient) versus delayed onset,( at the threshold chosen for RBC transfusion) of EPO ALFA

    RBC transfusion dependence will be defined by requirement of at least transfusions of 2 PRBC within an interval of less than 8 weeks, given for Hb \<8g/dl or \<9g/dl according to comorbidities and in the absence of other cause of anemia (bleeding, surgery…), taking into account only transfusions given at least 12 weeks after onset of treatment with EPO ALFA.

    12 weeks

Secondary Outcomes (3)

  • Erythroid response (according to IWG 2006 criteria)

    12 weeks

  • response duration to EPO ALFA

    4 years

  • Overall survival

    4 years

Study Arms (2)

Early onset arm

EXPERIMENTAL

Intervention: early onset of Eprex60000 IU/week , at patient inclusion

Drug: EPREX

Delayed onset arm

EXPERIMENTAL

Intervention: late introduction of Eprex60000 IU/week, whenever the patient reaches the level chosen RBC transfusions (based on age, comorbidities, anticipated tolerance of anemia).

Drug: EPREX

Interventions

EPREXDRUG

60 000 U/week for at least 12 weeks

Also known as: Epoetin alfa
Delayed onset armEarly onset arm

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • MDS according to WHO 2016 criteria, with low or int 1 classical IPSS
  • Non-RBC transfusion dependent anemia
  • Hb level between 9 and 10.5g/dl (at the center's lab)
  • Hb level should be at least 1g/dl higher than the Hb threshold chosen to start RBC transfusions based on age, comorbidities and predicted clinical tolerance of anemia (this transfusion threshold should be chosen between 8 and 9g/dl)
  • Serum EPO level \<500U/l
  • No other cause of anemia (including iron deficiency, vitamin B12 or B9 deficiency, hemolysis, hypothyroidism….)
  • Performance status \<=2

You may not qualify if:

  • Higher risk MDS (IPSS intermediate-2 or high)
  • Del 5q
  • Baseline Hemoglobin level \> 10.5 g/dl or \<9g/dl
  • Transfusion threshold (based on age , comorbidities…) \>9g/dl
  • Transfusion threshold less than 1 g/dl below baseline Hb level
  • CMML , if \>10 % BM blasts or WBC\>13.000/mm3
  • Uncontrolled hypertension
  • Uncontrolled cardiovascular disease including angina pectoris or cardiac failure
  • Renal failure: Creatinine clearance\<40ml/min (using MDRD formula)
  • Pregnancy (positive bettaHCG) or nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

Chu Amiens

Amiens, France

Location

CH Angers

Angers, 49 000, France

Location

CH Avignon

Avignon, 84000, France

Location

Centre Hospitalier de La Cote Basque

Bayonne, 64100, France

Location

Hopital Nord Franche-Comté

Belfort, 90015, France

Location

CHU de Besançon

Besançon, 25030, France

Location

Hopital Avicenne

Bobigny, 9300, France

Location

Hôpital Morvan

Brest, 29609, France

Location

CHU de Caen

Caen, 14033, France

Location

CH de Sevigné

Cesson, 35510, France

Location

CH de Cholet

Cholet, 49325, France

Location

CHU Estaing

Clermont-Ferrand, 63000, France

Location

CHSF Gilles de Corbeil

Corbeil-Essonnes, 91100, France

Location

Hôpital Henri-Mondor

Créteil, 94010, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

Centre Hospitalier du Mans

Le Mans, 72000, France

Location

Clinique Victor Hugo

Le Mans, 72000, France

Location

Hopital Saint-Vincent de Paul

Lille, 59160, France

Location

CHRU Limoges

Limoges, 87042, France

Location

Centre Hospitalier Lyon Sud

Lyon, 69495, France

Location

IPC

Marseille, 13273, France

Location

Centre Hospitalier du Mont de Marsan

Mont-de-Marsan, 40000, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CHU de Nice

Nice, France

Location

Hopital St Louis T4

Paris, 75475, France

Location

Centre Hospitalier Joffre-Perpignan

Perpignan, 66046, France

Location

Sophie Dimicoli-Salazar

Pessac, 33604, France

Location

CH de Périgueux

Périgueux, 24019, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

CHR d'Annecy

Pringy, 74374, France

Location

CHRU de Reims

Reims, 51092, France

Location

CHU Pontchaillou

Rennes, 35033, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

CH Saint Nazaire

Saint-Nazaire, 44600, France

Location

Centre Hospitalier Universitaire de STRASBOURG

Strasbourg, 67098, France

Location

IUCT Oncopole

Toulouse, 31059, France

Location

CH de Troyes

Troyes, 10003, France

Location

CH Valence

Valence, 26953, France

Location

CHU Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Sophie Park, Prof

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomazed study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2017

First Posted

July 21, 2017

Study Start

March 26, 2018

Primary Completion

September 21, 2023

Study Completion (Estimated)

October 1, 2028

Last Updated

March 11, 2025

Record last verified: 2025-03

Locations

FR(39)