Lenalidomide in Subject With Low and Intermediate-1 Risk MDS and Without Chromosome 5 Abnormality.
NCT ID: NCT01718379
Last Updated: 2016-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
132 participants
INTERVENTIONAL
2010-07-31
2016-06-30
Brief Summary
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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.
Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Lenalidomide 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
Lenalidomide
Lenalidomide:10 mg per day during 21 days
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 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
Epoetin beta
Epoetin beta: 60,000 Units/week.
Interventions
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Lenalidomide
Lenalidomide:10 mg per day during 21 days
Epoetin beta
Epoetin beta: 60,000 Units/week.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Roche Pharma AG
INDUSTRY
Groupe Francophone des Myelodysplasies
OTHER
Responsible Party
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Principal Investigators
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Andréa TOMA, MD
Role: PRINCIPAL_INVESTIGATOR
Groupe Francophone des Myelodysplasies
François Dreyfus, MD
Role: STUDY_DIRECTOR
Groupe Francophone des Myelodysplasies
Locations
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Hematology Dpt, Service d'Hématologie Clinique
CHU Albert Michallon, Grenoble, France
Hematology Dpt, CHR La Source orléans
Orléans, Orléans, France
Chu Amiens
Amiens, , France
CHU Angers
Angers, , France
Hematology Dpt, CH d'Avignon-305 rue Follereau-
Avignon, , France
CH de la Cote Basque
Bayonne, , France
centre de Blois
Blois, , France
Hopital Avicenne
Bobigny, , France
Hematology Dpt, CHU Haut-Lévèque
Bordeaux, , France
Hôpital Boulogne Sur Mer
Boulogne-sur-Mer, , France
hôpital Morvan
Brest, , France
CHU Clémenceau
Caen, , France
CH de Carcassonne
Carcassonne, , France
Hematology Dpt, CH René Dubos
Cergy-Pontoise, , France
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
CH de Compiègne
Compiègne, , France
Hematology Dpt, Hôpital Sud Francilien
Corbeil-Essonnes, , France
hopital Henri Mondor
Créteil, , France
CHU de Dijon
Dijon, , France
Hematology Dpt, Hôpital Versailles
Le Chesnay, , France
Hematology Dpt,CH Le mans
Le Mans, , France
CHRU Huriez
Lille, , France
Hopital Saint-Vincent de Paul
Lille, , France
CHRU de Limoges
Limoges, , France
Hematology Dpt, Centre Hospitalier Lyon Sud
Lyon, , France
CH de Mantes-la-jolie
Mantes-la-Jolie, , France
Institut Paoli Calmettes
Marseille, , France
Hematology Dpt, CHU Brabois
Nancy, , France
Hematology Dpt, CHU de nantes
Nantes, , France
Hematology Dpt, CHU Archet
Nice, , France
Hematology Dpt, CHU Caremeau
Nîmes, , France
Hematology Dpt, Hôpital la pitié-Salpétrière
Paris, , France
Hematology Dpt, Hopital Saint Louis
Paris, , France
Hopital Saint Antoine
Paris, , France
centre René Huguenin
Paris Saint Cloud, , France
Hematology Dpt, Hôpital Maréchal Joffre
Perpignan, , France
Hôpital Jean Bernard
Poitiers, , France
Hematology Dpt, Centre Hospitalier de la région d'Annecy
Pringy, , France
CHRU de Reims
Reims, , France
CHU Pontchaillou
Rennes, , France
Centre Henri Becquerel
Rouen, , France
CH de Saint Quentin
Sint Quentin, , France
Chu Strasbourg
Strasbourg, , France
Hematology Dpt, CHU PURPAN
Toulouse, , France
Hematology Dpt, CH CHU Bretoneau
Tours, , France
Hematology Dpt, CHU de Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, France
Hematology Dpt, CHU Cochin
Paris, Île-de-France Region, France
centre hopitalier princesse Grace
Monaco, , Monaco
Countries
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References
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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.
Other Identifiers
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GFM-Len-Epo-08
Identifier Type: -
Identifier Source: org_study_id