A Study of AG-946 in Participants With Anaemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS).

Start 24 Feb 2023 · Status Authorised, recruiting · 8 EU/EEA countries · 28 sites · Protocol AG946-C-002

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Authorised, recruiting

Participants planned 131

Countries 8

Sites 28

Anemia Due to Lower-Risk Myelodysplastic Syndromes

Phase 2a: To establish proof-of-concept (POC) for AG-946 in participants with lower-risk myelodysplastic syndromes (LR-MDS). Phase 2b: To evaluate the effect of AG-946 on transfusion independence (TI) in participants with LR-MDS

Key facts

Sponsor: Agios Pharmaceuticals Inc.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
Trial duration: 24 Feb 2023 → ongoing
Decision date (initial): 2023-02-06
Transition trial: No
Low-intervention: No
Rare-disease indication: Yes
Vulnerable population: Yes
Funding sources: Agios Pharmaceuticals, Inc.

External identifiers

EU CT number: 2022-500609-42-00
WHO UTN: U1111-1281-5849
ClinicalTrials.gov: NCT05490446

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Pharmacodynamic, Therapy, Safety, Efficacy, Pharmacokinetic, Diagnosis

Phase 2a: To establish proof-of-concept (POC) for AG-946 in participants with lower-risk myelodysplastic syndromes (LR-MDS).
Phase 2b: To evaluate the effect of AG-946 on transfusion independence (TI) in participants with LR-MDS

Secondary objectives 2

Phase 2a: 1. To evaluate the safety of AG-946 2. To evaluate the effect of AG-946 on additional measures of anemia 3. To evaluate the effect of AG-946 on transfusion burden (participants with LTB only) 4. To evaluate the pharmacokinetics of AG-946, 5.To evaluate the effect of AG-946 on pharmacodynamic biomarkers.
Phase 2b: 1. To evaluate the safety of AG-946 2. To evaluate the effect of AG-946 on anemia 3. To evaluate the effect of AG-946 on additional measures of transfusion burden 4. To evaluate the pharmacokinetics of AG-946 5. To evaluate the effect of AG-946 on pharmacodynamic biomarkers

Conditions and MedDRA coding

Anemia Due to Lower-Risk Myelodysplastic Syndromes

Version	Level	Code	Term	System organ class
20.0	LLT	10002272	Anemia	10005329
21.1	PT	10028533	Myelodysplastic syndrome	100000004864

Study design 10 periods

#	Title	Allocation	Blinding	Arms
1	Phase 2a Screening Participant eligibility will be determined during the Screening Period.The Investigator will confirm each participant’s eligibility before enrollment. Screening extensions will not be granted.	Not Applicable	None
2	Phase 2b End of Study The end of the study is defined as the time at which all participants complete all study visits, are lost to follow-up, have withdrawn consent for further participation in the study, or when the Sponsor terminates the study. Study completion is the date of the last visit of the last participant in the study. A participant in the Phase 2b part of the study is considered to have completed the study if they have completed the last visit shown in the Phase 2b schedule of assessments.	Not Applicable	None
3	Phase 2a Core Eligible participants will receive 5 mg AG-946 for QD oral administration.	Not Applicable	None
4	Phase 2a Extension Participants who complete the 16-week Core Period will be eligible to continue receiving the same dose of AG-946 for up to 156 weeks in the Extension Period.	Not Applicable	None
5	Phase 2a Safety Follow up Participants will receive a visit approximately 4 weeks after the last dose of study drug	Not Applicable	None
6	Phase 2a End of Study The end of the study is defined as the time at which all participants complete all study visits, are lost to follow-up, have withdrawn consent for further participation in the study, or when the Sponsor terminates the study. Study completion is the date of the last visit of the last participant in the study. A participant in the Phase 2a part of the study is considered to have completed the study if they have completed the last visit shown in the Phase 2a schedule of assessments .	Not Applicable	None
7	Phase 2b Screening Participant eligibility will be determined during the Screening Period. The Investigator will confirm each participant’s eligibility before enrollment. Screening extensions will not be granted.	Not Applicable	None
8	Phase 2b Core Period Eligible participants will receive 10 mg QD AG-946 (Dose Level 1), 15 mg QD AG-946 (Dose Level 2), or 20 mg QD AG-946 (Dose Level 3) for QD oral administration.	Not Applicable	None	Dose level 1: 10 mg QD of AG-946 Dose level 2: 15 mg QD of AG-946 Dose level 3: 20 mg QD of AG-946
9	Phase 2b Extension At the discretion of the Investigator, participants who complete the 24-week Core Period will be eligible to continue receiving the same dose of AG-946 for up to 156 weeks in the Extension Period. Intrapatient dose escalation up to 20 mg QD may be considered.	Not Applicable	None	Dose level 1: 10 mg QD of AG-946 Dose level 2: 15 mg QD of AG-946 Dose level 3: 20 mg QD of AG-946
10	Phase 2b Safety Follow Up Participants will receive a visit approximately 4 weeks after the last dose of study drug	Not Applicable	None

Regulatory references

Plan to share IPD: No

EU CT number	Title	Sponsor
2020-000691-38	A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers and in Subjects with Sickle Cell Disease, Estudio de fase 1 para evaluar la seguridad, tolerabilidad, farmacocinética y farmacodinámica de AG-946 en voluntarios sanos y sujetos con anemia de células falciformes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

Phase 2a: 1. At least 18 years of age at the time of providing informed consent 2. Documented diagnosis of MDS according to World Health Organization (WHO) classification, that meets IPSS-R classification of lowerrisk disease (risk score: ≤3.5) and <5% blasts as determined by the participant’s bone marrow biopsy/aspirate during the Screening Period 3. Nontransfused or with LTB, based on transfusion history from the participant’s medical record, according to revised IWG 2018 criteria: a. NTD: <3 RBC units in the 16-week period before administration of the first dose of study drug and no transfusions in the 8-week period before administration of the first dose of study drug, or b. LTB: 3 to 7 RBC units in the 16-week period before administration of the first dose of study drug and <4 RBC units in the 8-week period before administration of the first dose of study drug 4. An Hb concentration <11.0 g/dL during the 4-week Screening Period 5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2 6. If taking iron chelation therapy, the iron chelation therapy dose must have been stable and started ≥56 days before administration of the first dose of study drug 7. Women of childbearing potential (WOCBP) must be abstinent of sexual activities that may result in pregnancy as part of their usual lifestyle or agree to use a highly effective method of contraception from the time of providing informed consent throughout the study and for 28 days after the last dose of study drug; if the highly effective method of contraception is hormonal contraception, then an acceptable barrier method must also be used. Men with partners who are WOCBP must be abstinent of sexual activities that may result in pregnancy as part of their usual lifestyle or agree to use a condom from the time of providing informed consent throughout the study and for 28 days after the last dose of study drug. 8. Written informed consent from the participant before any study-related procedures are conducted and willing to comply with all study procedures for the duration of the study
Phase 2b: 1. At least 18 years of age at the time of providing informed consent 2. Documented diagnosis of MDS according to WHO classification, that meets IPSS-R classification of lower-risk disease (risk score: ≤3.5) and <5% blasts as determined by the participant’s bone marrow biopsy/aspirate during the Screening Period 3. With LTB or HTB, based on transfusion history from the participant’s medical record according to revised IWG 2018 criteria: a. LTB: 3 to 7 RBC units from at least 2 transfusion episodes in the 16-week period before administration of the first dose of study drug AND <4 RBC units in the 8-week period before administration of the first dose of study drug, or b. HTB: ≥8 RBC units in the 16-week period before administration of the first dose of study drug AND ≥4 RBC units in the 8-week period before administration of the first dose of study drug If a participant’s transfusion burden does not fall into either the LTB or HTB category, as defined per IWG 2018 criteria, then the transfusion burden will be categorized based on their transfusion history in the 16-week period before administration of the first dose of study drug. 4. Pretransfusion Hb concentration available for a minimum of 2 and at least half (50%) of the transfusions received in the 16-week period before administration of the first dose of study drug 5. An Hb concentration <10.0 g/dL during the 4-week Screening Period 6. Up to 2 prior therapies including erythropoiesis-stimulating agents (ESAs) (eg, erythropoietin [EPO], EPO + granulocyte colony-stimulating factor [G-CSF]) and/or luspatercept 7. ECOG Performance Status score of 0, 1, or 2 8. If taking iron chelation therapy, the iron chelation therapy dose must have been stable and started ≥56 days before administration of the first dose of study drug 9. WOCBP must be abstinent of sexual activities that may result in pregnancy as part of their usual lifestyle or agree to use a highly effective method of contraception from the time of providing informed consent throughout the study and for 28 days after the last dose of study drug; if the highly effective method of contraception is hormonal contraception, then an acceptable barrier method must also be used. Men with partners who are WOCBP must be abstinent of sexual activities that may result in pregnancy as part of their usual lifestyle or agree to use a condom from the time of providing informed consent throughout the study and for 28 days after the last dose of study drug. 10. Written informed consent from the participant before any study-related procedures are conducted and willing to comply with all study procedures for the duration of the study

Exclusion criteria 22

1.Known history of acute myeloid leukemia
18.Known allergy to AG-946 or its excipients (silicified microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, and the Opadry® II Blue film coat [polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol, talc, FD&C blue #2/indigo carmine aluminum lake/E132])
19.Pregnant or breastfeeding
13.Absolute neutrophil count <500/μL (0.5 × 109/L)
20.Any medical, hematologic, psychological, or behavioural condition(s) or prior or current therapy that, in the opinion of the Investigator, may confer an unacceptable risk to participating in the study and/or could confound the interpretation of the study data
10.For any malignancy, except MDS: History of malignancy (active or treated) ≤5 years before providing informed consent, except for no melanomatous skin cancer in situ, cervical carcinoma in situ, or breast carcinoma in situ.
2.Secondary MDS, defined as MDS that is known to have arisen as a result of chemical injury or treatment with chemotherapy and/or radiation for other diseases
Phase 2a: 3. Prior exposure to a pyruvate kinase activator, and/or disease-modifying agents for underlying MDS: • Immunomodulatory drugs (IMiDs) such as lenalidomide at the Investigator’s discretion and in consultation with the Medical Monitor, participants who received ≤1 week of treatment with IMiDs may not be excluded, provided their last dose was ≥8 weeks before administration of the first dose of study drug. • Hypomethylating agents (HMAs); at the Investigator’s discretion and in consultation with the Medical Monitor, participants who received ≤2 doses of HMAs may not be excluded, provided that their last dose was ≥8 weeks before administration of the first dose of study drug • Isocitrate dehydrogenase (IDH) inhibitors • Immunosuppressive therapy (IST) • Allogeneic or autologous stem cell transplant
4.Currently receiving treatment with luspatercept, EPO, or G-CSF. Treatment with EPO or G-CSF must have been stopped for ≥28 days before administration of the first dose of study drug; treatment with luspatercept must have been stopped for ≥65 days before administration of the first dose of study drug (phase 2a) or randomization (phase 2b).
15.Nonfasting triglyceride concentration >500 mg/dL
16.Receiving inhibitors of P-glycoprotein that have not been stopped for ≥5 days or a time frame equivalent to 5 half-lives (whichever is longer) before administration of the first dose of study drug
6.History of hepatobiliary disorders, as defined by: a. Serum AST >2.5 × ULN (unless due to hemolysis and/or hepatic iron deposition) and ALT >2.5 × ULN (unless due to hepatic iron deposition) b. Serum bilirubin >ULN, if the elevation is associated with clinically symptomatic choledocholithiasis, cholecystitis, biliary obstruction, or hepatocellular disease
5.History of active and/or uncontrolled cardiac or pulmonary disease within 6 months before providing informed consent, including but not limited to: a.New York Heart Association Class III or IV heart failure or clinically significant dysrhythmia. b.Myocardial infarction, unstable angina pectoris, or unstable hypertension; high risk thrombosis; hemorrhagic, embolic, or thrombotic stroke; deep venous thrombosis; or pulmonary or arterial embolism c.Heart rate–corrected QT interval using Fridericia’s method of ≥470 milliseconds for female participants and ≥450 milliseconds for male participants, except for right or left bundle branch block d.Severe pulmonary fibrosis as defined by severe hypoxia, evidence of right-sided heart failure, and radiographic pulmonary fibrosis >50% e.Severe pulmonary hypertension as defined by severe symptoms associated with hypoxia, right-sidedheart failure, and oxygen indicated
Phase 2b: 21. Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, autoimmune or hereditary hemolytic anemia, hypothyroidism, or any type of known clinically significant bleeding.
7. Renal dysfunction, as defined by an estimated glomerular filtration rate (eGFR) <45mL/min/1.73 m2
8.Active infection requiring systemic antimicrobial therapy at the time of providing informed consent. If antimicrobial therapy is required during the Screening Period, screening procedures should not be performed while antimicrobial therapy is being administered, and the last dose of antimicrobial therapy must be administered ≥7 days before administration of the first dose of study drug
14.Platelet count ≤75,000/μL (75 × 109/L) during Screening; platelet transfusions within 28 days before or during Screening
9.Major surgery within 12 weeks before administration of the first dose of study drug. Participants must have completely recovered from any previous surgery before administration of the first dose of study drug.
11. Positive test for hepatitis C virus antibodywith evidence of active HCV infection, or positive test for hepatitis B surface antigen (HBsAg)
12.Positive test for HIV-1 Ab or HIV-2 Ab
17.Current enrolment or past participation (within 4 weeks or a time frame equivalent to 5half-lives of the investigational study drug before administration of the first dose of study drug or, whichever is longer) in any other clinical study involving an investigational treatment or device
Phase 2b: 3. Prior exposure to a pyruvate kinase activator, including exposure to AG-946 in the Phase 2a part of this study, and/or disease-modifying agents for underlying MDS: • Imetelstat; at the Investigator’s discretion and in consultation with the Medical Monitor, participants who received ≤2 doses of imetelstat may not be excluded, provided that their last dose was ≥8 weeks before administration of the first dose of study drug • IMiDs such as lenalidomide; at the Investigator’s discretion and in consultation with the Medical Monitor, participants who received ≤1 week of treatment with IMiDs may not be excluded, provided their last dose was ≥8 weeks before administration of the first dose of study drug • HMAs; at the Investigator’s discretion and in consultation with the Medical Monitor, participants who received ≤2 doses of HMAs may not be excluded, provided that their last dose was ≥8 weeks before administration of the first dose of study drug • IDH inhibitors • IST • Allogeneic or autologous stem cell transplant

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

Phase 2a 1. Hemoglobin (Hb) response, defined as a≥1.5-g/dL increase from baseline in the average Hb concentration from Week 8 through Week16 2 Transfusion independence (TI), defined as transfusion-free for ≥8consecutive weeks during the Core Period (participants with low transfusion burden [LTB] only)
Phase 2b Transfusion independence, defined as transfusion-free for ≥8 consecutive weeks (TI8) during the Core Period

Secondary endpoints 7

Phase 2a: 1. AEs, SAEs, discontinuations due to AEs, and laboratory abnormalities during the Core Period 2. Hb 1.0+ response, defined as a≥1.0-g/dL increase from baseline in the average Hb concentration from Week 8through Week16 3. Change from baseline in Hb concentration during the Core Period
Phase 2a: 4. ≥1.5-g/dL increase from baseline in the Hb concentration at ≥2 consecutive time points from Week 8 through Week 16 5. Change from baseline in total transfused red blood cell (RBC) units during the Core Period 6. ≥50% reduction in total transfused RBC units for ≥8 consecutive weeks during the Core Period compared with baseline
Phase 2a: 7. Plasma concentration and pharmacokinetic parameters of AG-946 during the Core Period 8. Whole blood concentrations of pharmacodynamic parameters, including 2,3-diphosphoglycerate (2,3-DPG) and adenosine triphosphate (ATP) during the Core Period
Phase 2b: 1. AEs, SAEs, discontinuations due to AEs, and laboratory abnormalities during the Core Period 2. Change from baseline in Hb concentration during the Core Period 3. Change from baseline in total transfused RBC units from Week 8 through Week 24
Phase 2b: 4. ≥50% reduction in total transfused RBC units for ≥8 consecutive weeks during the Core Period compared with baseline (participants with high transfusion burden [HTB] only) 5. Time to first TI8 during the Core Period 6. Transfusion-free for ≥12 consecutive weeks (TI12)during the Core Period
Phase 2b: 7. ≥50% reduction in total transfused RBC units for ≥12 consecutive weeks during the Core Period compared with baseline (participants with HTB only) 8. Time to first TI12 during the Core Period 9. Duration of TI, defined as the longest transfusion-free period during the Core Period
Phase 2b: 10. Plasma concentration and pharmacokinetic parameters of AG-946 during the Core Period 11. Whole blood concentrations of pharmacodynamic parameters, including 2,3-DPG and ATP during the Core Period

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

AG-946

PRD10509078 · Product

Active substance: AG-946
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 25200 mg milligram(s)
Max treatment duration: 180 Week(s)
Authorisation status: Not Authorised
MA holder: AGIOS PHARMACEUTICALS
Paediatric formulation: No
Orphan designation: No

AG-946

PRD9469412 · Product

Active substance: AG-946 Phosphate
Pharmaceutical form: COATED TABLET
Route of administration: ORAL
Max daily dose: 20 mg milligram(s)
Max total dose: 25200 mg milligram(s)
Max treatment duration: 180 Week(s)
Authorisation status: Not Authorised
MA holder: AGIOS PHARMACEUTICALS
Paediatric formulation: No
Orphan designation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Agios Pharmaceuticals Inc.

Sponsor organisation: Agios Pharmaceuticals Inc.
Address: 88 Sidney Street
City: Cambridge
Postcode: 02139-4137
Country: United States

Scientific contact point

Organisation: Agios Pharmaceuticals Inc.
Contact name: Scientific Communications

Public contact point

Organisation: Agios Pharmaceuticals Inc.
Contact name: Scientific Communications

Third parties 25

Organisation	City, country	Duties
Millmount Healthcare Limited ORG-100011724	Stamullen, Ireland	Code 14
PPD Global Central Labs (S) Pte Ltd ORG-100041754	Singapore, Singapore	Laboratory analysis
Transperfect Translations International Inc. ORG-100043494	New York, United States	Other
Centogene GmbH ORG-100043695	Rostock, Germany	Other, Laboratory analysis
Neogenomics Laboratories Inc. ORG-100041804	Aliso Viejo, United States	Other, Laboratory analysis
Neogenomics Laboratories Inc. ORG-100041804	Houston, United States	Other, Laboratory analysis
PPD Global Ltd. ORG-100007531	Marousi, Greece	Code 10, Code 11, Code 12, Code 13, Code 2, Code 5, Data management, Code 8, Code 9
QPS LLC ORG-100012847	Newark, United States	Other, Laboratory analysis
Fortrea Inc. ORG-100012602	Durham, United States	Other
PPD International Holdings LLC ORG-100007655	Zaventem, Belgium	Laboratory analysis
Suvoda LLC ORG-100043523	Conshohocken, United States	Interactive response technologies (IRT)
Molecular Pathology Laboratory Network Inc. ORG-100047681	Maryville, United States	Other, Laboratory analysis
PPD ORG-100029763	Copenhagen S, Denmark	Code 10, Code 11, Code 12, Code 13, Code 2, Code 5, Data management, Code 8, Code 9
Xogene Services LLC ORG-100042779	Englewood, United States	Other
Endpoint And Outcomes Research LLC ORG-100044473	Boston, United States	Other
Pharmaceutical Product Development LLC ORG-100016999	Highland Heights, United States	Laboratory analysis
Riverark Limited ORG-100026657	London, United Kingdom	Code 9
CGC Centro De Genetica Clinica E Patalogia S.A. ORG-100044796	Porto, Portugal	Other
Verasafe LLC ORG-100044685	Washington, United States	Other
QPS LLC ORG-100012847	Newark, United States	Other, Laboratory analysis
Quest Diagnostics Nichols Institute ORG-100012789	San Juan Capistrano, United States	Other, Laboratory analysis
Scout Clinical ORG-100042228	Dallas, United States	Other
Neogenomics Inc. ORG-100044076	Fort Myers, United States	Other, Laboratory analysis
Veeva Systems Inc. ORG-100006053	Pleasanton, United States	E-data capture
Intrinsic Lifesciences LLC ORG-100044000	La Jolla, United States	Other, Laboratory analysis

Locations

8 EU/EEA countries · 28 investigational sites

By country

Country	MS status	Planned subjects	Sites
Austria	Ended	4	2
Czechia	Ended	3	2
France	Ended	8	3
Germany	Ended	6	1
Greece	Ended	8	4
Italy	Ongoing, recruitment ended	10	6
Poland	Ongoing, recruitment ended	25	2
Spain	Ongoing, recruitment ended	14	8
Rest of world United Kingdom, United States, Israel, Turkey, Australia, Korea, Republic of	—	53	—

Investigational sites

Austria

2 sites · Ended

Ordensklinikum Linz GmbH

Interne 1 - Hämatologie mit Stammzelltransplantation, Hämostaseologie und medizinische Onkologie, Fadingerstraße 1, 4020, Linz

Medical University Of Vienna

Clinical Department of Hematology and Haemostasiology, Waehringer Guertel 18-20, Alsergrund, Vienna

Czechia

2 sites · Ended

Vseobecna Fakultni Nemocnice V Praze

1st Medical Department, Karlovo Namesti 554 32, 120 00, Prague 2

University Hospital Ostrava

Department of Haematooncology, 17 Listopadu 1790 5, 708 00, Ostrava Poruba

France

3 sites · Ended

Assistance Publique Hopitaux De Marseille

HÉMATOLOGIE ET THÉRAPIE CELLULAIRE, 144 Rue Saint Pierre, 13005, Marseille

Hopital Saint Louis

Service d'Hématologie Senior, 1 Avenue Claude Vellefaux, 75010, Paris

Centre Hospitalier Universitaire D Angers

Hématologie, 4 Rue Larrey, 49933, Angers Cedex 9

Germany

1 site · Ended

Universitaetsklinikum Duesseldorf AöR

Klink für Hämatologie, Onkologie und Klinische Immunologie, Moorenstraße 5, Bilk, Düsseldorf

Greece

4 sites · Ended

Democritus University Of Thrace

Hematology department, Building 5, Dragana Campus, Alexandroupolis

Ippokratio General Hospital Of Thessaloniki

Hematology Unit, 2nd Clinic of Internal Medicine, Konstadinoupoleos 49, 546 42, Thessaloniki

University General Hospital Attikon

Hematology Unit of 2nd Propaedeutic Internal Medicine Clinic, Rimini Street 1, 124 62, Athens

General University Hospital Of Patras

Hematology Unit – Clinic of Internal Medicine, Rio, 265 04, Patras

Italy

6 sites · Ongoing, recruitment ended

Humanitas Research Hospital

Sezione Leucemia e Mielodisplasia, Via Alessandro Manzoni 56, 20089, Rozzano

Fondazione IRCCS Policlinico San Matteo

Ematologia, Viale Camillo Golgi 19, 27100, Pavia

Azienda Ospedaliera Ordine Mauriziano Di Torino

Dipartimento di Scienze Cliniche e Biologiche, Via Ferdinando Magellano 1, 10128, Turin

Grande Ospedale Metropolitano Bianchi Melacrino Morelli

U.O.C. di Ematologia, Viale Europa, 89133, Reggio Calabria

Azienda Ospedaliera Policlinico Universitario Tor Vergata

Dipartimento di Biomedicina e Prevenzione, Viale Oxford 81, 00133, Rome

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Ematologia, Via Francesco Sforza 28, 20122, Milan

Poland

2 sites · Ongoing, recruitment ended

Pratia S.A.

Department of Hematology and Cancer Prevention, Ul. Ligocka 103, 40-568, Katowice

Pratia Hematologia Sp. z o.o.

n/a, Ul. Ligocka 103, 40-568, Katowice

Spain

8 sites · Ongoing, recruitment ended

University Hospital Virgen Del Rocio S.L.

Hematología, Avenida De Manuel Siurot S/n, 41013, Sevilla

Catalan Institute Of Oncology

N/A, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat

Hospital Universitario De Salamanca

Instituto de Investigación Biomédica de Salamanca, Paseo De San Vicente 58-182, 37007, Salamanca

Hospital Universitario Hm Sanchinarro

Hematología y Hemoterapia, Calle Ona 10, 28050, Madrid

Hospital Universitario Reina Sofia

Hematología, Avenida Menendez Pidal S/n, 14004, Cordoba

Hospital Universitari Vall D Hebron

Hematology Unit, IOB Institute of Oncology, Passeig De La Vall D Hebron 119-129, 08035, Barcelona

Hospital Universitario La Paz

Servicio de Hematologia, Paseo Castellana 261, 28046, Madrid