Hematology Department

Founding & Legal Framework

Established by: Presidential Decree (PD) 459/87 (Government Gazette 215/8-12-1987)
Ministerial Decision of Installation: Y4a/29261/03 (Government Gazette 750/11-6-2003)
Internal Rules of Operation: PD 185/99 (Government Gazette 173/27-8-1999), amended by Rector’s Decision DUTH/DDK/TDA/49066/5370/1009 (Government Gazette 2558/16-06-2021) – addition of Short-Stay Unit.

Specialized Units

Thalassemia Unit: Established by PD 185/99, focused on the effective management of children and adults with thalassemia.
High-Dose Therapy & Cellular Therapies Unit: Originally established as a Bone Marrow Transplantation unit, renamed by Ministerial Decision 2202/B1/15-03-2005 (Government Gazette 328/15-03-2005). Focuses on autologous transplants and cellular therapies.
Short-Stay Unit: Provides blood transfusions, chemotherapy, immunotherapy, and medical procedures requiring several hours of stay without overnight hospitalization.

Introduction
The Hematology Clinic specializes in the diagnosis and prevention of hematological diseases, as well as the hospitalization and treatment of patients with hematological disorders. Its scope also includes the education of medical students and specialized physicians.

Faculty Members (Academic Staff)

Ioannis Kotsianidis: Professor of Hematology
Emmanouil Spanoudakis: Associate Professor of Hematology
Konstantinos Liapis: Associate Professor of Hematology

Laboratory & Support Staff (ETEP)

Maria Rigopoulou: Secretarial Support
Ioanna-Vasiliki Bazntiara: Biologist – Laboratory Support

Other Personnel

Zoi Bezirgiannidou: Hematologist, NHS Consultant Director
Menelaos Papoutselis: Hematologist, NHS Consultant (Grade B)
Christoforos Roumpakis: Hematologist, NHS Consultant (Grade B)
Panagiota Giassari: Pediatrician, NHS Consultant Director (Thalassemia Unit)
Aikaterini Pentidou: Hematologist, Auxiliary Physician
Georgios Vrachiolias: Hematologist, External Associate
Eleftheria Lamprianidou: Molecular Biologist, External Associate
Dimitrios Koparanis: Molecular Biologist, External Associate
Theodoros Spyropoulos: Molecular Biologist, External Associate
Despoina Dimitriou: Molecular Biologist, External Associate
Athanasios Tasis: Molecular Biologist, External Associate
Christina Rimpa: Molecular Biologist, External Associate
Chrysa Kymparidou: Molecular Biologist, External Associate
Georgios Karakikes: Auxiliary Staff, Secretarial Support
Kyriaki Marmara: Bioethics Specialist, Secretarial Support
Athanasia Katergari: Secretarial Support
Evangelia Kaitantzi: Secretarial Support
Contact Information
Hematology Clinic, University General Hospital of Alexandroupoli (PGNA),
Dragana Area,
68100 Alexandroupoli, Greece

Education
- Hematology – 5th Year (Medical Students
- Introduction to Clinical Immunology

Research

The Hematology Clinic maintains an extensive and multifaceted research portfolio, as reflected in numerous scientific publications in prestigious, high-impact international journals and multiple awards at international and national scientific conferences. The Clinic’s research primarily focuses on the study of immune regulation and the signaling architecture of malignant hematopoiesis, specifically at the translational level, aiming to identify prognostic and predictive biomarkers as well as molecular mechanisms of resistance to current therapies.

The Hematology Clinic has received or participates in 5 major competitive programs:

a) H.F.R.I. (ELIDEK) METAHEM: Immunometabolic regulation of the hematopoietic stem cell niche in myelodysplasia and aging.
b) EYDE ETAK (Research – Create – Innovate) MDS-Target: Development of an innovative prognostic method for treatment with hypomethylating agents in patients with myelodysplastic syndrome.
c) H.F.R.I. (ELIDEK) PURECELL: Towards Precision Medicine: Advanced cellular analytics in biomedical research, in collaboration with CERTH.
d) H.F.R.I. (ELIDEK) personaCLLized: Innovative approach for personalized prediction and health assessment.

e) “Regional Excellence Support” Program

In addition, 20 new international publications were indexed in PubMed during 2020. Notable highlights include a study in Blood Advances (the 2nd most prestigious journal worldwide in its field) and another in Blood Cancer Journal (ranked 6th). Furthermore, the Clinic participated—as the sole Greek representative—in a pioneering publication by the International MDS Working Group in Nature Medicine, along with 5 other high-impact international studies.

Specifically, the research covers the following fields/diseases:

Myelodysplastic syndromes, normal and leukemic hematopoiesis, and PNH (Paroxysmal Nocturnal Hemoglobinuria)
Multiple Myeloma
Myeloproliferative Neoplasms
Lymphoproliferative Disorders
Immunoregulation in Cardiology and Pulmonary diseases

Services

Specialized High-Dose Therapy & Cellular Therapies Unit
Specialized Thalassemia Unit
Specialized Short-Stay Unit
Regular Outpatient Clinics

Programs & Clinical Trials

M19-708 (VIALE-M): A randomized, open-label, 2-arm, multicenter, Phase 3 study of Venetoclax and Azacitidine versus Best Supportive Care as maintenance therapy in patients with Acute Myeloid Leukemia (AML) in first remission following conventional chemotherapy.
2215-CL-0302 (Phase 3): A multicenter, randomized, double-blind, placebo-controlled study of the FLT3 inhibitor Gilteritinib (ASP2215) administered as maintenance therapy following induction/consolidation therapy in patients with FLT3/ITD AML in first complete remission.
M16-043: A randomized, double-blind, placebo-controlled study of Venetoclax co-administered with low-dose Cytarabine versus low-dose Cytarabine in treatment-naïve patients with Acute Myeloid Leukemia who are ineligible for intensive chemotherapy.
P-3001 (Phase 3): A Phase 3, randomized, controlled, open-label clinical trial of Pevonedistat in combination with Azacitidine versus Azacitidine monotherapy as first-line treatment for patients with higher-risk Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML) with low blast counts.
CMBG453B12201: A randomized, double-blind, placebo-controlled Phase 2 multicenter study of intravenous MBG453 as an add-on to hypomethylating agents in adult patients with intermediate, high, or very high-risk Myelodysplastic Syndrome (MDS) according to IPSS-R criteria.
AZA-MDS-003 (Phase 3) – (Completed): A multicenter, randomized, double-blind study evaluating the efficacy and safety of oral Azacitidine plus best supportive care versus placebo plus best supportive care in patients with transfusion-dependent anemia and thrombocytopenia due to low-risk MDS.
PASS – (Completed): A prospective, non-interventional post-authorization safety study, designed as a disease registry for patients with transfusion-dependent Myelodysplastic Syndromes (MDS), with low or intermediate-1 IPSS risk and isolated del(5q).

20180117: An open-label, Phase 2 trial for the treatment of patients with first or second relapse of Multiple Myeloma using Carfilzomib, Pomalidomide, and Dexamethasone (KPd).
ARROW 2 (Phase 3): A randomized, open-label Phase 3 study comparing once-weekly versus twice-weekly Carfilzomib in combination with Lenalidomide and Dexamethasone in patients with relapsed or refractory Multiple Myeloma.
INSIGHT – MM (Phase IV): A global, prospective, non-interventional, observational study of presentation, treatment patterns, and outcomes in multiple myeloma patients.
C16048: A non-interventional, prospective observational study of patients with relapsed/refractory Multiple Myeloma treated with Ninlaro to evaluate progression-free survival (PFS), treatment continuation rate, quality of life, patient satisfaction, and treatment compliance in everyday clinical practice in Greece.
CLBH589D2408: A post-authorization safety study (PASS) of Panobinostat; a non-interventional study of Panobinostat in combination with Bortezomib and Dexamethasone in patients with relapsed and/or refractory Multiple Myeloma (RRMM).
20150262: Real-world evidence on the use of Carfilzomib among patients with relapsed Multiple Myeloma in Europe.
20167750: An observational study to evaluate the effects of Carfilzomib on bone disease in patients with relapsed and/or refractory Multiple Myeloma receiving Carfilzomib according to standard clinical practice.

NIS-GEN-POM-001: A retrospective medical record review and prospective follow-up study to evaluate the efficacy of Pomalidomide in combination with low-dose Dexamethasone in patients with relapsed/refractory Multiple Myeloma under real-world clinical conditions.
C16029 (Phase 2/3): A Phase 2/3, randomized, open-label study comparing oral Ixazomib/Dexamethasone versus oral Pomalidomide/Dexamethasone in relapsed and/or refractory Multiple Myeloma.
LEGEND (Completed): A retrospective chart review study of outcomes for second-line treatment with Lenalidomide/Dexamethasone in Greek patients with relapsed/refractory Multiple Myeloma and therapeutic models following disease progression.
GSK207503 – DREAMM-7: A multicenter, open-label, randomized Phase III study to evaluate the efficacy and safety of the combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) compared to the combination of Daratumumab, Bortezomib, and Dexamethasone (D-Vd) in participants with relapsed/refractory Multiple Myeloma.
CMBG453B12301: A randomized, double-blind, placebo-controlled, multicenter Phase III study of Azacitidine with or without MBG453 for the treatment of patients with intermediate, high, or very high-risk Myelodysplastic Syndrome (MDS) per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2).
MIRACLLE: A two-year epidemiological, prospective cohort study to record real-world first and second-line management strategies, treatment outcomes, quality of life, and resource utilization in patients with Chronic Lymphocytic Leukemia (CLL) in Greece.
ML 30133 (Phase IV) – (Completed): A multicenter, single-arm, non-interventional observational study of Obinutuzumab to evaluate the efficacy, safety, and cost of disease management in patients with Chronic Lymphocytic Leukemia and comorbidities in Greece

CA180-696 (Phase IV) – (Completed): Management of Chronic Myeloid Leukemia (CML) with Dasatinib in real-world clinical practice conditions.
H19-476 – (Completed): “Retrospective analysis of clinical outcomes in patients with relapsed/refractory Chronic Lymphocytic Leukemia (R/R CLL) treated with Venetoclax: A retrospective analysis from Greece.”
P19-568 – CONCRETE: “Clinical outcomes of patients with relapsed/refractory Chronic Lymphocytic Leukemia (R/R CLL) treated with Venetoclax in everyday clinical practice conditions in Greece.”
OMB 110918 (Phase III) – (Completed): A Randomized, Open-label Study of Ofatumumab and Bendamustine Combination versus Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin Lymphoma refractory to Rituximab or a Rituximab-containing regimen during or within six months of treatment.
PCYC1143: A phase 3 study of Ibrutinib in combination with Venetoclax in subjects with Mantle Cell Lymphoma.
GS-EU-313-4171 ZEUS: Non-interventional study to evaluate the safety profile of Idelalisib in patients with refractory Follicular Lymphoma (FL).
ESCAPE (Phase IV) – (Completed): Observational study of the impact on quality of life, efficacy, and safety of Ruxolitinib in patients with primary or secondary Myelofibrosis following Polycythemia Vera or Essential Thrombocythemia.
ERASER (Phase IV) – (Completed): Observational study on the efficacy and safety of Tasigna in newly diagnosed patients with Chronic Myeloid Leukemia.
ACE-536-MF-002 – INDEPENDENCE: A Phase 3, double-blind, randomized study to compare the efficacy and safety of Luspatercept (ACE-536) versus placebo in patients with Myeloproliferative Neoplasm-associated Myelofibrosis, receiving concurrent JAK2 inhibitor therapy and requiring red blood cell transfusions.
BO 42161: A randomized, open-label, active-controlled, multicenter Phase III study to evaluate the efficacy and safety of Crovalimab versus Eculizumab in adult and adolescent patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) currently receiving treatment with complement inhibitors.
BO 42162: A randomized, open-label, active-controlled, multicenter Phase III study to evaluate the efficacy and safety of Crovalimab versus Eculizumab in adult and adolescent patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who are treatment-naïve to complement inhibitors.
International PNH Registry: For patients receiving or not receiving Soliris – (Completed).
CMBG453B12203: A single-arm, open-label Phase II study of Sabatolimab in combination with Azacitidine and Venetoclax in adult participants with high or very high-risk Myelodysplastic Syndrome (MDS) according to IPSS-R criteria.
ACE-536-MDS-002 – COMMANDS: A Phase 3, open-label, randomized study to compare the efficacy and safety of Luspatercept (ACE-536) versus Epoetin Alfa for the treatment of anemia due to very low, low, or intermediate-risk Myelodysplastic Syndromes (MDS) per IPSS-R, in ESA-naïve patients requiring red blood cell transfusions.
SLSG18-301: A randomized, open-label study of the efficacy and safety of Galinpepimut-S (GPS) maintenance monotherapy, compared to investigator’s choice of Best Available Therapy, in patients with Acute Myeloid Leukemia (AML) who achieved complete remission following second-line salvage therapy.
P22-535 – SURVIVE: A prospective non-interventional study to describe the efficacy and safety of Venetoclax as first-line treatment in patients with Acute Myeloid Leukemia (AML) ineligible for intensive chemotherapy in routine clinical practice in Greece.
H21-923 – SECURE: Real-world treatment patterns and clinical outcomes in patients with AML ineligible for intensive chemotherapy in Greece, receiving first-line systemic therapy or best supportive care.
MANIFEST: A randomized, double-blind, active-controlled Phase 3 study of Pelabresib (CPI-0610) in combination with Ruxolitinib versus placebo and Ruxolitinib in JAK inhibitor-naïve patients with Myelofibrosis (MF).
H23-122 – METER: A multinational, real-world study investigating treatment patterns, efficacy, and healthcare resource utilization in patients diagnosed with Myelofibrosis through medical record review.
CC-5013-MCL-005: A non-interventional, post-authorization safety study (PASS) of patients with relapsed or refractory Mantle Cell Lymphoma to further investigate and characterize the relationship between Lenalidomide, tumor flare reaction, and high tumor burden.
AG-946-C-002: A Phase 2a/2b, open-label, proof-of-concept (Phase 2a) and double-blind, randomized, placebo-controlled (Phase 2b), multicenter study of the efficacy and safety of AG-946 in participants with anemia due to low-risk Myelodysplastic Syndromes.
54179060CML3004: A randomized, controlled, open-label, multicenter, seamlessly integrated Phase 2/3 study of Ibrutinib in combination with Rituximab versus investigator’s choice of either Lenalidomide plus Rituximab or Bortezomib plus Rituximab in participants with relapsed or refractory Mantle Cell Lymphoma.
CMBG453B12206B: An open-label, multicenter, rollover study for patients who have completed a previous Novartis-sponsored Sabatolimab (MBG453) study and are judged by the investigator to benefit from continued treatment with Sabatolimab.
CA055-026: A Phase 2/3, multicenter, randomized, dose-optimization (Part I), double-blind (Part II) study comparing the efficacy and safety of oral Azacitidine (oral-Aza, ONUREG) plus Best Supportive Care (BSC) versus placebo plus BSC in participants with low or intermediate-risk Myelodysplastic Syndrome (MDS) per IPSS-R.
EUMELEIA: An investigator-initiated, Phase II, multicenter, open-label, single-arm, prospective clinical trial to evaluate the efficacy and safety of alternating Bortezomib-based regimens in combination with Daratumumab followed by Daratumumab maintenance as frontline therapy for primary Plasma Cell Leukemia: a trial by the Greek Myeloma Study Group – the EUMELEIA study.
- REAL IMM: “Real-world Innovation in Multiple Myeloma – REAL IMM”
- EMN30: “Phase 3 study of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone in participants with newly diagnosed multiple myeloma as maintenance therapy following autologous stem cell transplantation.”

Links:
- Activity of the Hematology Clinic
- Hematology Clinic Website

Hematology Department

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