Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT05181735
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2021-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000621232', 'term': 'luspatercept'}, {'id': 'D000068817', 'term': 'Epoetin Alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-06-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2021-12-20', 'studyFirstSubmitQcDate': '2021-12-20', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A : Dose-finding study', 'timeFrame': 'Evaluation of Dose-limiting toxicity (DLT) at Day 21 of cycle 1 for non-hematological toxicity , up to day 42 for hematological toxicity', 'description': 'To determine the optimal dose level in terms of both toxicity and efficacy for luspatercept + EPO'}, {'measure': 'Part B : Benefit of the association over the monotherapy', 'timeFrame': 'At week 25', 'description': 'To determine, at Week 25, the superiority and efficacy of luspatercept + ESA over luspatecept alone'}], 'secondaryOutcomes': [{'measure': 'Response rate', 'timeFrame': '3 months', 'description': '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'}, {'measure': 'Response duration', 'timeFrame': '24 months', 'description': 'Duration of response ends with date loss of response, relapse or death whichever occurs first'}, {'measure': 'Overall survival', 'timeFrame': '30 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MDS', 'LR-MDS', 'Luspatercept', 'Eprex', 'ESA'], 'conditions': ['MDS', 'Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'Study of the combination of luspatercept in low-risk myelodysplastic syndrom (LR-MDS) without ring sideroblasts (RS) having failed or being ineligible to ESA', 'detailedDescription': 'Part A of the trial=Dose-finding Study: Determination the optimal dose level in terms of both toxicity and efficacy for luspatercept + ESA\n\nPart B : Determination of the superiority and efficacy of the association Luspatercept+ESA (erythroipoiesis Stimulating Agent) over luspatercept alone in patients with lower risk MDS who failed to achieve a response or who subsequently relapsed after ESA, wihtout disease progression'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must meet all of the following criteria to participate in the study:\n\n* Myelodysplastic syndrome according to current WHO classification\n* Age ≥ 18 years\n* 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)\n* Hemoglobin \\< 9 gr/dl or Transfusion dependant (at least 3 RBCs in 16 wk in at least 2 transfusion episodes)\n* Non del(5q) syndrome\n* Adequat renal function, defined by creatinine less than 1.5 times the upper limit of normal, creatinine clearance ≥ 40 mL/min (MDRD formula).\n* Adequat liver function, defined by total bilirubin and transaminases less than 1.5 times the upper limit of normal.\n* Patient is not known to be refractory to platelet transfusions.\n* Written informed consent.\n* Patient must understand and voluntarily sign consent form.\n* Patient must be able to adhere to the visit schedule as outlined in the study and follow protocol requirements.\n* ECOG performance status 0-2 at the time of screening.\n* A FCBP (female of childbearing potential) for this study was defined as a sexually mature woman who: (1) had not undergone a hysterectomy or bilateral oophorectomy; or (2) had not been naturally postmenopausal (amenorrhea following cancer therapy did not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months). A FCBP participating in the study must:\n\n * Have had 2 negative pregnancy tests as verified by the investigator prior to starting IP (unless the screening pregnancy test was done within 72 hours of Cycle 1 Day 1). She must have had agreed to ongoing a monthly pregnancy testing during the course of the study and after EOT\n * If sexually active, agreed to have used, and been able to comply with, highly effective contraception\\*\\* without interruption, 5 weeks prior to starting IP, during treatment with IP (including dose interruptions), and for 12 weeks after discontinuation of IP.\n * \\*\\* Highly effective contraception was defined in this protocol as the following (information also appeared in the ICF): Hormonal contraception (eg, birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device, tubal ligation (tying your tubes), or a partner with a vasectomy\n* Male subjects must: Have agreed to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (eg, polyurethane), during sexual contact with a pregnant female or a FCBP while participating in the study, during dose interruptions, and for at least 12 weeks following IP discontinuation, even if he had undergone a successful vasectomy\n\nExclusion Criteria:\n\nA patient meeting any of the following criteria is not eligible to participate in the study:\n\n* Severe infection or any other uncontrolled severe condition.\n* Uncontrolled hypertension\n* Significant cardiac disease - NYHA Class III or IV or having suffered a myocardial infarction in the last 6 months.\n* del(5q) syndrome\n* Use of investigational agents within 30 days or any anticancer therapy (including IMiD) within 2 weeks before the study entry with the exception of hydroxyurea. The patient must have recovered at least a grade 1 from all acute toxicity from any previous therapy.\n* Use of EPO within 4 weeks before the study entry\n* Active cancer, or cancer during the year prior to trial entry other than basal cell carcinoma, or carcinoma in situ of the cervix or breast.\n* Patient already enrolled in another therapeutic trial of an investigational drug.\n* Known HIV infection or active hepatitis B or C.\n* Women who are or could become pregnant or who are currently breastfeeding.\n* Any medical or psychiatric contraindication that would prevent the patient from understanding and signing the informed consent form.\n* Patient eligible for allogeneic stem cell transplantation.\n* Known allergies to luspatercept or EPO or any of its excipients.\n* No affiliation to a health insurance system.'}, 'identificationModule': {'nctId': 'NCT05181735', 'briefTitle': 'Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Francophone des Myelodysplasies'}, 'officialTitle': 'A Randomized Phase I/ II Multicenter Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA', 'orgStudyIdInfo': {'id': 'COMBOLA'}, 'secondaryIdInfos': [{'id': '2021-000596-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (Luspatercept alone)', 'description': 'Patients will receive Luspatercept 1mg/kg (every 3 weeks) with titration up to max of 1.75mg/kg, subcutaneously on day 1 of each 21 day cycle (every three weeks).', 'interventionNames': ['Drug: Luspatercept Injection [Reblozyl]']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B (Luspatercept + EPREX)', 'description': 'Patients will receive Luspatercept (at the selected dose according to part A) subcutaneously on day 1 of each 21 day cycle (every three weeks) AND Epoetin alfa: At the selected dose (in part A) per week, subcutaneously, every week\n\nDoses schedules Part A :\n\n* Level 1 : Luspatercept 0.8 mg/kg + EPREX 30000 UI\n* Level 2 : Luspatercept 1.33 mg/kg + EPREX 30000 UI\n* Level 3 : Luspatercept 1.75mg/kg + EPREX 30000 UI\n* Level 4 : Luspatercept 1.75mg/kg + EPREX 60000 UI', 'interventionNames': ['Drug: Luspatercept Injection [Reblozyl]', 'Drug: Eprex']}], 'interventions': [{'name': 'Luspatercept Injection [Reblozyl]', 'type': 'DRUG', 'otherNames': ['ACE-536'], 'description': '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', 'armGroupLabels': ['Arm A (Luspatercept alone)', 'Arm B (Luspatercept + EPREX)']}, {'name': 'Eprex', 'type': 'DRUG', 'otherNames': ['Epoietin alfa'], 'description': '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', 'armGroupLabels': ['Arm B (Luspatercept + EPREX)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Etienne PAUBELLE, Dr', 'role': 'CONTACT', 'email': 'paubelle.etienne@chu-amiens.fr', 'phone': '+33 3 22 45 59 14'}, {'name': 'Etienne PAUBELLE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Amiens-Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '80090', 'city': 'Amiens', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bérengère GRUSON, MD', 'role': 'CONTACT', 'email': 'bgruson@vivalto-sante.com', 'phone': '+33 3 60 12 76 87'}, {'name': 'Bérengère GRUSON, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Clinique de l'Europe", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49933', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sylvain THEPOT, Dr', 'role': 'CONTACT', 'email': 'sylvain.thepot@chu-angers.fr', 'phone': '+33 2 41 35 44 66'}, {'name': 'Sylvain THEPOT, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '95107', 'city': 'Argenteuil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benjamin PAPOULAR, Dr', 'role': 'CONTACT', 'email': 'benjamin.papoular@ch-argenteuil.fr', 'phone': '+33 1 34 23 20 16'}, {'name': 'Benjamin PAPOULAR, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Victor Dupouy', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '84000', 'city': 'Avignon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Borhane SLAMA, Dr', 'role': 'CONTACT', 'email': 'bslama@ch-avignon.fr', 'phone': '+33 4 32 75 93 94'}, {'name': 'Borhane SLAMA, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CH Henri Duffaut d'Avignon", 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '64109', 'city': 'Bayonne', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Delphine MARTINEAU, MD', 'role': 'CONTACT', 'email': 'dmartineau@ch-cotebasque.fr', 'phone': '+33 5 59 44 38 32'}, {'name': 'Delphine MARTINEAU, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de la Côte Basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '93009', 'city': 'Bobigny', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thorsten BRAUN, Pr', 'role': 'CONTACT', 'email': 'thorsten.braun@aphp.fr', 'phone': '+33 1 48 95 70 51'}, {'name': 'Thorsten BRAUN, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '35510', 'city': 'Cesson-Sévigné', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Violaine DONCKER, MD', 'role': 'CONTACT', 'email': 'violainedoncker@gmail.com', 'phone': '+33 2 23 21 05 50'}, {'name': 'Anne-Violaine DONCKER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Privé Sévigné', 'geoPoint': {'lat': 48.1212, 'lon': -1.603}}, {'zip': '38043', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathieu MEUNIER, Dr', 'role': 'CONTACT', 'email': 'MMeunier2@chu-grenoble.fr', 'phone': '+33 4 76 76 62 77'}, {'name': 'Mathieu MEUNIER, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '78150', 'city': 'Le Chesnay', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne Laure TAKSIN, Dr', 'role': 'CONTACT', 'email': 'altaksin@ght78sud.fr', 'phone': '+33 1 39 63 92 60'}, {'name': 'Anne Laure TAKSIN, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Versailles', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pirayeh EFTEKHARI, Dr', 'role': 'CONTACT', 'email': 'pirayeh.eftekhari@aphp.fr', 'phone': '+33 1 45 21 25 34'}, {'name': 'Pirayeh EFTEKHARI, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '72037', 'city': 'Le Mans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Kamel LARIBI, Dr', 'role': 'CONTACT', 'email': 'klaribi@ch-lemans.fr', 'phone': '+33 2 43 43 43 61'}, {'name': 'Kamel LARIBI, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '59037', 'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laure GOURSAUD, Dr', 'role': 'CONTACT', 'email': 'laure.goursaud@chu-lille.fr', 'phone': '+33 3 20 44 42 90'}, {'name': 'Laure GOURSAUD, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHRU de Lille - Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Pierre GOURIN, Dr', 'role': 'CONTACT', 'email': 'marie-pierre.gourin@chu-limoges.fr', 'phone': '+33 5 55 05 66 42'}, {'name': 'Marie-Pierre GOURIN, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHRU de Limoges - Hôpital Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '40000', 'city': 'Mont-de-Marsan', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Reza TABRIZI, Dr', 'role': 'CONTACT', 'email': 'reza.tabrizi@ch-mdm.fr', 'phone': '+33 5 58 05 11 62'}, {'name': 'Reza TABRIZI, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Mont de Marsan', 'geoPoint': {'lat': 43.89022, 'lon': -0.49713}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Franciane PAUL, MD', 'role': 'CONTACT', 'email': 'f-paul@chu-montpellier.fr', 'phone': '+33 4 67 33 22 54'}, {'name': 'Franciane PAUL, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Saint Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alice GARNIER, Dr', 'role': 'CONTACT', 'email': 'Alice.GARNIER@chu-nantes.fr', 'phone': '+33 2 40 08 32 71'}, {'name': 'Alice GARNIER, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Nantes - Hôtel Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44277', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jacques DELAUNAY, MD', 'role': 'CONTACT', 'email': 'jacques.delaunay@groupeconfluent.fr', 'phone': '+33 2 28 27 21 16'}, {'name': 'Jacques DELAUNAY, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital privé du Confluent', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06202', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thomas CLUZEAU, Pr', 'role': 'CONTACT', 'email': 'cluzeau.t@chu-nice.fr', 'phone': '+33 4 92 03 58 39'}, {'name': 'Thomas CLUZEAU, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Nice - Hôpital Archet 1', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30029', 'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stefan WICKENHAUSER, Dr', 'role': 'CONTACT', 'email': 'stefan.WICKENHAUSER@chu-nimes.fr', 'phone': '+33 4 66 68 40 33'}, {'name': 'Stefan WICKENHAUSER, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '45067', 'city': 'Orléans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ali ARAR, Dr', 'role': 'CONTACT', 'email': 'ali.arar@chr-orleans.fr', 'phone': '+33 2 38 22 95 46'}, {'name': 'Ali ARAR, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "CHR d'Orléans", 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lionel ADES, Pr.', 'role': 'CONTACT', 'email': 'lionel.ades@aphp.fr', 'phone': '+33 1 71 20 70 21'}, {'name': 'Lionel ADES, Pr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise WILLEMS, Dr', 'role': 'CONTACT', 'email': 'lise.willems@aphp.fr', 'phone': '+33 1 58 41 21 20'}, {'name': 'Lise Willems, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cécile BALLY, Dr', 'role': 'CONTACT', 'email': 'cecile.bally@aphp.fr', 'phone': '+33 1 44 49 53 42'}, {'name': 'Cécile BALLY, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie DIMICOLI-SALAZAR, Dr', 'role': 'CONTACT', 'email': 'sophie.dimicoli-salazar@chu-bordeaux.fr', 'phone': '+33 5 57 65 65 11'}, {'name': 'Sophie DIMICOLI-SALAZAR, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Bordeaux - Hôpital Haut-Lévêque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '24019', 'city': 'Périgueux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Claire CALMETTES, Dr', 'role': 'CONTACT', 'email': 'claire.calmettes@ch-perigueux.fr', 'phone': '+33 5 53 45 25 85'}, {'name': 'Claire CALMETTES, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Périgueux', 'geoPoint': {'lat': 45.18691, 'lon': 0.71439}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Maël HEIBLIG, MD', 'role': 'CONTACT', 'email': 'mael.heiblig@chu-lyon.fr', 'phone': '+33 4 78 86 22 34'}, {'name': 'Maël HEIBLIG, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '86021', 'city': 'Poitiers', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jose Miguel TORREGROSA-DIAZ, Dr', 'role': 'CONTACT', 'email': 'jose-miguel.torregrosa-diaz@chu-poitiers.fr', 'phone': '+33 5 49 44 44 44', 'phoneExt': '45415'}, {'name': 'Jose Miguel TORREGROSA-DIAZ, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '95300', 'city': 'Pontoise', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Riad BENRAMDANE, Dr', 'role': 'CONTACT', 'email': 'riad.benramdane@ght-novo.fr', 'phone': '+33 1 30 75 47 41'}, {'name': 'Riad BENRAMDANE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital NOVO', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'zip': '29107', 'city': 'Quimper', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lenaïg LE CLECH, MD', 'role': 'CONTACT', 'email': 'l.leclech@ch-cornouaille.fr', 'phone': '+33 2 98 52 67 31'}, {'name': 'Lenaïg LE CLECH, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Cornouaille', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'zip': '35033', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stanislas NIMUBONA, Dr', 'role': 'CONTACT', 'email': 'stanislas.nimubona@chu-rennes.fr', 'phone': '+33 2 99 28 42 91'}, {'name': 'Stanislas NIMUBONA, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Rennes - Hôpital Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76038', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aspasia STAMATOULLAS, Dr', 'role': 'CONTACT', 'email': 'aspasia.stamatoullas@chb.unicancer.fr', 'phone': '+33 2 32 08 22 88'}, {'name': 'Aspasia STAMATOULLAS, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42271', 'city': 'Saint-Priest-en-Jarez', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Silvia Maria BEZSERA, Dr', 'role': 'CONTACT', 'email': 'silviamaria.bezsera@chu-st-etienne.fr', 'phone': '+33 4 77 91 71 46'}, {'name': 'Silvia Maria BEZSERA, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Institut de Cancérologie et d'Hématologie Universitaire de Saint-Etienne", 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}, {'zip': '67000', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anaïse BLOUET, Dr', 'role': 'CONTACT', 'email': 'ablouet@solcrr.org', 'phone': '+33 3 88 45 37 50'}, {'name': 'Anaïse BLOUET, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Strasbourg Oncologie Libérale Clinique Sainte Anne', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thibault COMONT, Dr', 'role': 'CONTACT', 'email': 'Comont.Thibault@iuct-oncopole.fr', 'phone': '+33 5 31 15 62 66'}, {'name': 'Thibault COMONT, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Toulouse - IUCT Oncopole', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37000', 'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel GYAN, Pr', 'role': 'CONTACT', 'email': 'emmanuel.gyan@univ-tours.fr', 'phone': '+33 2 47 25 87 78'}, {'name': 'Emmanuel GYAN, Pr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Tours - Hôpital Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '26000', 'city': 'Valence', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clémence SANTANA, MD', 'role': 'CONTACT', 'email': 'clemence.santana@ch-valence.fr', 'phone': '+33 4 75 75 25 92'}, {'name': 'Clémence SANTANA, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de Valence', 'geoPoint': {'lat': 44.9256, 'lon': 4.90956}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': "Maud D'AVENI-PINEY, Pr", 'role': 'CONTACT', 'email': 'm.daveni-piney@chru-nancy.fr', 'phone': '+33 3 83 15 32 82'}, {'name': "Maud D'AVENI-PINEY, Dr", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHRU Nancy - Hôpitaux de Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Fatiha CHERMAT', 'role': 'CONTACT', 'email': 'fatiha.chermat-ext@aphp.fr', 'phone': '+33 1 71 20 70 59'}, {'name': 'Karine LEMARIE', 'role': 'CONTACT', 'email': 'karine.lemarie-ext@aphp.fr', 'phone': '+33 1 71 20 70 54'}], 'overallOfficials': [{'name': 'Lionel ADES, Pr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Saint Louis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Francophone des Myelodysplasies', 'class': 'OTHER'}, 'collaborators': [{'name': 'Celgene', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}