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Myelodysplastic SyndromesPhase 2NCT01718379

Lenalidomide in Subject With Low and Intermediate-1 Risk MDS and Without Chromosome 5 Abnormality.

A Phase 2 study testing Lenalidomide and Epoetin beta in people with Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 48 sites in 2 countries.

Completed

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

Official record
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Trial summary

The goal of the present study is to assess, through a randomized phase II trial, the efficacy and safety of Lenalidomide with or without Epoetin beta in transfusion-dependent, ESA-resistant, IPSS low and intermediate-1 risk MDS patients without chromosome 5 abnormality. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndromes
What is being tested?
Lenalidomide and Epoetin beta
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
48 sitesin 2 countries
Study dates
Jul 2010to Jun 2016
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • MDS defined as
  • Low or int-1 IPSS score
  • Documented absence of chromosome 5 abnormality (del(5q) or -5 karyotype)
  • De novo MDS, excluding therapy-related MDS AND
  • Transfusion dependance (requirement of at least 4 units of RBC transfusions every 8 weeks )
  • Resistance or loss of response to a previous treatment with Epoetin alpha/beta (at least 60,000 Units/w) or Darbepoetin (at least 250 µg/w), for at least 12 weeks
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  • Ineligibility for allogeneic stem cell transplantation or intensive chemotherapy during the next 12 months
  • ECOG performance status ≤ 2
  • Age ≥ 18 years
  • Life expectancy ≥ 3 months
  • Adequate liver function (transaminases serum levels ≤ 3N)
  • Adequate renal function (calculate creatinine clearance > 50 ml/min)
  • Female subjects of chilbearing potential* must :
  • Agree to use effective contraception without interruption throughout the study and for at least 4 weeks after the end of treatment
  • Men must: Agree to not conceive during the treatment and to use effective contraception during the treatment period (including periods of dose reduction or temporary suspension) and during one week after end of treatment if their partner is of childbearing potential.

Who cannot join

  • Active serious infection not controlled by oral or intravenous antibiotics
  • Platelets less than 50 G/L
  • Prior history of deep vein thrombosis or pulmonary embolism
  • Previous treatment by Thalidomide
  • Treatment with any investigational antileukemic agent or chemotherapy at least 6 weeks prior to study entry and lack of full recovery from side effects due to prior therapy independent of when that therapy were given
  • Rapidely progressive disease with copromised organ function judged to be life-threatening by the Investigator
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  • Pregnant or lactating female
  • Known human immunodeficiency virus (HIV) infection
  • Known active hepatitis B and/or C virus infection
  • Hypersensitivity or intolerance to Lenalidomide or any of the excipients
  • Hypersensitivity to Epoetin beta or any of the excipients
  • Uncontrolled arterial hypertension
  • Any history of malignancy (other than myelodysplastic syndrome) unless the patient has remained disease free for more than 5 years

Trial locations and contacts

48 sites in 2 countries.

48 sites in 2 countries

France47 sites

  • Chu Amiens

    Amiens, 80054

  • CHU Angers

    Angers, 43033

  • Hematology Dpt, CH d'Avignon-305 rue Follereau-

    Avignon, 84000

  • CH de la Cote Basque

    Bayonne, 64 100

  • centre de Blois

    Blois, 41016

  • Hopital Avicenne

    Bobigny, 93009

  • Hematology Dpt, CHU Haut-Lévèque

    Bordeaux, 33604

  • Hôpital Boulogne Sur Mer

    Boulogne-sur-Mer, 62321

  • hôpital Morvan

    Brest, 29609

  • CHU Clémenceau

    Caen, 14033

  • CH de Carcassonne

    Carcassonne, 11890

  • Hematology Dpt, CH René Dubos

    Cergy-Pontoise, 95303

  • Hematology Dpt, Service d'Hématologie Clinique

    CHU Albert Michallon, Grenoble, 38043

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63058

  • CH de Compiègne

    Compiègne, 60321

  • Hematology Dpt, Hôpital Sud Francilien

    Corbeil-Essonnes, 91100

  • hopital Henri Mondor

    Créteil, 94010

  • CHU de Dijon

    Dijon, 21034

  • Hematology Dpt, Hôpital Versailles

    Le Chesnay, 78157

  • Hematology Dpt, CHU de Bicêtre

    Le Kremlin-Bicêtre, Île-de-France Region, 94275

  • Hematology Dpt,CH Le mans

    Le Mans, 72037

  • CHRU Huriez

    Lille, 59037

  • Hopital Saint-Vincent de Paul

    Lille, 59160

  • CHRU de Limoges

    Limoges, 87046

  • Hematology Dpt, Centre Hospitalier Lyon Sud

    Lyon, 69495

  • CH de Mantes-la-jolie

    Mantes-la-Jolie, 78201

  • Institut Paoli Calmettes

    Marseille, 13009

  • Hematology Dpt, CHU Brabois

    Nancy, 54511

  • Hematology Dpt, CHU de nantes

    Nantes, 44093

  • Hematology Dpt, CHU Archet

    Nice, 06202

  • Hematology Dpt, CHU Caremeau

    Nîmes, 30029

  • Hematology Dpt, CHR La Source orléans

    Orléans, Orléans, 45067

  • Hematology Dpt, Hôpital la pitié-Salpétrière

    Paris, 75013

  • Hematology Dpt, Hopital Saint Louis

    Paris, 75475

  • Hopital Saint Antoine

    Paris, 75571

  • Hematology Dpt, CHU Cochin

    Paris, Île-de-France Region, 75679

  • centre René Huguenin

    Paris Saint Cloud, 92210

  • Hematology Dpt, Hôpital Maréchal Joffre

    Perpignan, 66046

  • Hôpital Jean Bernard

    Poitiers, 86021

  • Hematology Dpt, Centre Hospitalier de la région d'Annecy

    Pringy, 74374

  • CHRU de Reims

    Reims, 51092

  • CHU Pontchaillou

    Rennes, 35033

  • Centre Henri Becquerel

    Rouen, 76038

  • CH de Saint Quentin

    Sint Quentin, 02321

  • Chu Strasbourg

    Strasbourg, 67098

  • Hematology Dpt, CHU PURPAN

    Toulouse, 31059

  • Hematology Dpt, CH CHU Bretoneau

    Tours, 37044

Other trials in France

Monaco1 site

  • centre hopitalier princesse Grace

    Monaco, 98012

Other trials in Monaco

About this study

Official title: A Phase II Study Evaluating the Efficacy/Safety of Lenalidomide With or Without Epoetin Beta in Transfusion-dependent ESA-resistant Patients With IPSS Low- and Intermediate-1 Risk Myelodysplastic Syndromes Without Chromosome 5 Abnormality.

The goal of the present study is to assess, through a randomized phase II trial, the efficacy and safety of Lenalidomide with or without Epoetin beta in transfusion-dependent, ESA-resistant, IPSS low and intermediate-1 risk MDS patients without chromosome 5 abnormality.

Patients will receive either Lenalidomide alone or Lenalidomide and Epoetin beta for 4 months. Responders will be eligible for maintenance treatment with cycles identical to the first cycles, until relapse occurs or until unacceptable toxicity.

Read the detailed description

This is a multi-center, open-label, randomized, Phase II study.

Patients will be treated either with arm A or B

  • Arm A: Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses.
  • Arm B: Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses combined with weekly subcutaneous injections of Epoetin beta (60,000 Units/w).

Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria.

Maintenance: responders will continue to follow the corresponding treatment arm until relapse occurs; non responders at Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria.

in arm A will be considered in failure of treatment and the introduction of Epoetin beta is at the discretion of the physician.

The patients will be followed every 3 months for 12 months

Being tested
Lenalidomide, Epoetin beta
Keywords
Myelodysplasia
Medical subject headings
Myelodysplastic Syndromes, Anemia, Refractory, with Excess of Blasts

What participants receive

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

  • LenalidomideDrug

    Also called Revlimid

    Lenalidomide:10 mg per day during 21 days

  • Epoetin betaDrug

    Also called NEORECORMON

    Epoetin beta: 60,000 Units/week.

Study groups in NCT01718379
Study groupRoleWhat they receive
Arm AExperimentalLenalidomide 10 mg/day for 21 days every 28 days for 4 courses. Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria. Maintenance: responders will continue to follow the corresponding treatment arm until relapse occurs; non responders at cycle 4 in arm A will be considered in failure of treatment and the introduction of Epoetin beta is at the discretion of the physician. The patients will be followed every 3 months for 12 months
Receives: Drug: Lenalidomide
Arm BExperimentalLenalidomide 10 mg/day for 21 days every 28 days for 4 courses combined with weekly subcutaneous injections of Epoetin beta (60,000 Units/w). Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria. Maintenance: responders will continue to follow the corresponding treatment arm until relapse occurs; non responders at cycle 4 in arm A will be considered in failure of treatment and the introduction of Epoetin beta is at the discretion of the physician. The patients will be followed every 3 months for 12 months
Receives: Drug: Epoetin beta

What is being measured

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

  1. Comparing the efficacy of Lenalidomide alone to Lenalidomide with Epoetin beta in transfusion-dependent ESA-resistant

    Primary outcome is a complete or partial response defined by the IWG 2006 criteria observed after 4 months of treatment. Comparison in the rate of response between the two groups will be performed with Chi-square test or if necessary Fisher exact test.

    Same analyzes will be performed with the IWG 2000 response definition .

    Measured: After 4 months of treatment

Secondary outcomes (1)

  1. will be to assess the safety of Lenalidomide and of its combination with Epoetin beta

    • Safety of Lenalidomide and of its combination with Epoetin beta: adverse events (type, frequency, severity) and relationship of adverse events to study drug
    • % of major HI-E and minor HI-E after 4 courses according to IWG 2000 criteria
    • Erythroid response duration
    • Time to response
    • Time to progression according to IPSS
    • RBC transfusion independence
    • Prognostic factors of response
    • Survival
    • Quality of life

    Measured: After 2 months of treatment

Timeline

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

  1. First posted31 Oct 2012 (estimated)
  2. Study startJul 2010
  3. Primary completionNov 2012
  4. Study completionJun 2016

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01718379
Sponsor's protocol ID
GFM-Len-Epo-08
Status last verified
Nov 2016
First submitted
23 Oct 2012
Last updated
8 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Chesnais V, Renneville A, Toma A, Lambert J, Passet M, Dumont F, Chevret S, Lejeune J, Raimbault A, Stamatoullas A, Rose C, Beyne-Rauzy O, Delaunay J, Solary E, Fenaux P, Dreyfus F, Preudhomme C, Kosmider O, Fontenay M; Groupe Francophone des Myelodysplasies. Effect of lenalidomide treatment on clonal architecture of myelodysplastic syndromes without 5q deletion. Blood. 2016 Feb 11;127(6):749-60. doi: 10.1182/blood-2015-04-640128. Epub 2015 Dec 1.

    PubMed 26626993

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide and Epoetin beta in people with Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 48 sites in 2 countries.

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 15 inclusion and 13 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 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in France, Monaco. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Comparing the efficacy of Lenalidomide alone to Lenalidomide with Epoetin beta in transfusion-dependent ESA-resistant (time frame: After 4 months of treatment). 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 NCT01718379, which also lists 1 linked publication.

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 8 Nov 2016.

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