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Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA

ConditionsMDSMyelodysplastic Syndromes
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGroupe Francophone des Myelodysplasies

About this trial

Study of the combination of luspatercept in low-risk myelodysplastic syndrom (LR-MDS) without ring sideroblasts (RS) having failed or being ineligible to ESA

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Myelodysplastic syndrome according to current WHO classification

Age ≥ 18 years

Patients with lower risk MDS according to IPSS classification (LOW, INT-1) without RS who failed to achieved a response or who subsequently relapse after ESA (at least 60000 U EPO-a over at least 12weeks or equivalent), without disease progression (or ineligible to ESA defined by EPO > 500 UI/l)

Hemoglobin < 9 gr/dl or Transfusion dependant (at least 3 RBCs in 16 wk in at least 2 transfusion episodes)

Disqualifiers

Severe infection or any other uncontrolled severe condition.

Uncontrolled hypertension

Significant cardiac disease - NYHA Class III or IV or having suffered a myocardial infarction in the last 6 months.

del(5q) syndrome

Trial design

Design model

Parallel

Treatments tested in this trial

  • Luspatercept Injection [Reblozyl]

    Drug

    All patients will receive Luspatercept subcutaneously on day 1 of each 21 day cycle (every 3 weeks) at the selected dose according to part A : 1.75mg/kg or 1.33 mg/kg or 0.8 mg/kg

  • Eprex

    Drug

    Epoietin alfa will be adminstered as a subcutaneous injection at the selected dose according to part A : 30 000 UI/week or 60 000 UI/week, every week

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Arm A (Luspatercept alone)Experimental treatment 1 intervention
Group B: Arm B (Luspatercept + EPREX)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part A : Dose-finding study

To determine the optimal dose level in terms of both toxicity and efficacy for luspatercept + EPO

Time frame
Evaluation of Dose-limiting toxicity (DLT) at Day 21 of cycle 1 for non-hematological toxicity , up to day 42 for hematological toxicity
2

Part B : Benefit of the association over the monotherapy

To determine, at Week 25, the superiority and efficacy of luspatercept + ESA over luspatecept alone

Time frame
At week 25

Secondary outcomes

1

Response rate

To determine the response rate (complete response (CR) +Partial Response (PR) + stable disease with Hematological Improvment (HI) according to IWG 2006 criteria) in each arm

Time frame
3 months
2

Response duration

Duration of response ends with date loss of response, relapse or death whichever occurs first

Time frame
24 months
3

Overall survival

Overall survival time ends for patients who die during the follow up period with the date of death and for patients who do not die during the follow up period with the date when the patient was last seen to be alive

Time frame
30 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Groupe Francophone des Myelodysplasies

Lead sponsor

Celgene

Collaborator

Source ClinicalTrials.gov
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