α/α

ΧΟΡΗΓΟΣ

ΑΚΡΩΝΥΜΙΟ

ΝΟΣΗΜΑ

ΕΝΔΕΙΞΗ

MAIN EXCLUSION CRITERIA

ΠΑΡΕΜΒΑΤΙΚΗ (ΝΑΙ/ΌΧΙ)

PHASE/ΤΥΠΟΣ

ΘΕΡΑΠΕΙΑ ΣΕ ΠΑΡΕΜΒΑΤΙΚΕΣ ΜΕΛΕΤΕΣ

ENTAΞΗ

ΛΗΞΗ ΕΝΤΑΞΗΣ ΑΣΘΕΝΩΝ

MD

CRC

25

AMGEN

PEDS ALL

ALL

<21yrs, R/R after blin, CAR-T or besponsa

prior carfilzomib, prior PI <3mos ago, prior VXLD, VPLD, R3 <2mos ago

ΝΑΙ

I/II

Carfizomib

ΝΑΙ

Μαρ-24

Tsokanas

Sagiadinou

26

SELLAS

REGAL

AML

CR2 or more

Systemic AML therapy and systemic immunosuppressive treament 4wks prior randomization, Acute promyelocytic leukemia

ΝΑΙ

III (ROL)

WT1 vaccine vs SOC

ΝΑΙ

Δεκ-23

Tsokanas

Sagiadinou

29

Παπαν. (ακαδημαικη)

Penta-ST

ALL DISEASES

HAPLO ALLO-SCT

GvHD, DLI/Campath/ATG 28ds prior infusion, prednisone >0.5mg/kg daily

ΝΑΙ

I/II

Penta-VST (ATMP)

ΝΑΙ

Δεκ-23

Liga

Sagiadinou

30

Alexion

TMA 313

TMA

ALLO-SCT

Shiga (+), DIC, VOD, ADAMTS13, Coombs (+)

ΝΑΙ

III (RDB)

Ravulizumab vs Placebo

ΝΑΙ

Δεκ-24

Liga

Sagiadinou

32

Abbvie

VIALE-T

AML

ALLO-SCT

AML therapy, blasts > 5%

ΝΑΙ

III (ROL)

Aza-Ven

ΝΑΙ

Νοε-23

Liga

Sagiadinou

33

AMGEN

GOLDEN

B-ALL (Ph-)

1L (>55y)

active CNS leukemia, currently on treatmen, other malignancy.

ΝΑΙ

III (ROL)

Blina vs SOC

ΝΑΙ

Σεπ-25

Verigou

Sagiadinou

34

ΟΚΤΑPΗ

PRO-SID

CLL

IgG low

IgG treatment 3months, major infection current or 6mos ago

ΝΑΙ

III (RDB)

Panzynga VS SOC

ΝΑΙ

Δεκ-24

Gkikas

Sagiadinou

36

ΠΑΤΡΑ (ακαδημαικη)

IG-TREGS

ALL DISEASES

SIBLING ALLO-SCT

actiVe GvHD, ATG gvhd prophylaxis

ΝΑΙ

I/II

iGTregs (ATMP)

ΝΑΙ

Δεκ-24

Liga (Gkikas)

Sagiadinou

37

BMS

KARMMA9

ΜΜ

induction (PI+/-IMID)+ Auto-SCT, PR/VGPR post auto

currently on consolidation/maintenance therapy, non-secretory MM, allo-SCT and other cellular therapies

ΝΑΙ

III (ROL)

Ide cel (CART) vs Len maint.

Noε-2023

2026

Liga

Sagiadinou

38

BMS

EXCAL-IBER

ΜΜ

induction (PI+/-IMID)+ Auto-SCT, at least PR post auto

PD or refractory to primary treatment, Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma

ΝΑΙ

III (ROL)

iberdomide vs Len maint

Noε-2023

2026

Labropoulou

Sagiadinou

39

EBMT (ακαδημαικη)

EBMT-HD

HL

bridging BV or CP for Auto

-

ΌΧΙ

IV (παρατήρησης)

bridging BV /  CPI

NAI

1/6/2024

Liga

Sagiadinou

40

EAE

MM

selinexor/vortezomib/dara as 2nd-4th line

ΌΧΙ

IV (παρατήρησης)

selinexor/vortezomib/dara

Ιαν-24

Δεκ-24

Labropoulou

Sagiadinou

41

KARTOS

KRT-232-115

MF

2L (Jak inhibitor) DIPSS High, intermediate-2, or intermediate-1 risk,

Prior splenectomy, Prior MDM2 inhibitor therapy or p53-directed therapy Prior allogeneic stem-cell transplant

ΝΑΙ

III (RDB)

navtemadlin vs jakavi

Μαρ-24

2026

42

Agios Pharmaceuticals

AG946-C-002

MDS

MDS low risk, Nontransfused (NTD: <3 RBC), Hb <11.0 g/dL

Secondary MDS, prior HMA, PK activators, IDH, allo-SCT,  Currently receiving treatment with luspatercept, EPO, or G-CSF

ΝΑΙ

II (RDB)

AG946

Ιαν-24

Δεκ-24

43

Celgene Corporation

ACE-506-MF-002

MPD

Jaki treated, RBC transfusions (4-12 RBC/12wks)

anemia from cause other than MPN-associated MForJAK2 inhibitor therapy,  use of hydroxyurea, immunomodulatory compounds such as pomalidomide, thalidomide, ESAs, androgenic steroids

ΝΑΙ

III (RDB)

Luspa vs placebo

Ιαν-24

9/2024

44

EAE

EAE115

MM

2L (PI/Len)

ΝΑΙ

II

isatuximab + Poma/Dexa

Ιαν-24

Μαρ-25

Labropoulou

45

EAE

EAE116

MM

NDMM, severe renal impairment

ΝΑΙ

II

isatuximab+Bor/Cy/Dexa

Ιαν-24

Μαρ-24

Labropoulou

46

Momenta/   Johnson & Johnson

MOM-M281-006

Autoimmune   Disorder

Warm Autoimmune Hemolytic Anemia

cold antibody autoimmune hemolytic anemia (AIHA), cold agglutinin syndrome, mixed type (that is, warm and cold) AIHA, or paroxysmal cold hemoglobinuria

ΝΑΙ

I/II

Nipocalimab

Ιαν-24

18/11/2024

47

Prothena

NEOD001-301

AL Amyloidosis

Mayo Stage IV

Non-AL amyloidosis, Prior treatment with plasma cell-directed chemotherapy, birtamimab, daratumumab, 11- 1F4, anti-serum amyloid P antibody, doxycycline for amyloid, Waldenström's macroglobulinemia and/or immunoglobulin M monoclonal gammopathy

ΝΑΙ

I/II

birtamimab+SOC VS placebo+SOC

Ιαν-24

Φεβ-24

48

Pharma Cosmos

P-SP-420-THAL-01

b-Thal

Transfusion-dependent, iron chelation treatment, Transfusion iron overload

MDS,  structural Hb variants HbS and HbC, S-ferritin <500 or >4000 ng/mL, Hypertransfused  (>6 units/month)

ΝΑΙ

I/II

SP-420

Ιαν-24

Σεπ-24

49

Novartis   AG

CABL001J12302

CML-CP

Ph (+), BCR:ABL1 transcript [e14a2 and/or e13a2],  at least 1L

CNS infiltration, Previous treatment of CML with chemo and/or biologic agents or prior stem cell transplant (except hydroxyurea)

ΝΑΙ

III (ROL)

asciminib vs nilotinib

Ιαν-24

Απρ-25

50

SANOFI

EFC15951 (IRAKLIA)

MM

R/R, at least 1L (Len+PI)

Primary refractory, refractory to anti-CD38, Prior therapy with pomalidomide, Active primary amyloid-light (AL) amyloidosis

ΝΑΙ

I/II

SC versus IV isatuximab + poma/dexa

Δεκ-23

7/12/2023

Labropoulou

51

NOVARTIS AG

CMBG453B12206B (rollover study)

MDS

MBG453 treated in Novartis study, responds to MBG453 treatment

has been permanently discontinued from sabatolimab treatment in the parent study, has been permanently discontinued from sabatolimab treatment in the parent study

ΝΑΙ

III (ROL)

MBG453+HMA

Ιαν-24

Μαρ-24

52

Celgene Corporation

CC-220-MM-002

MM

R/R

Prior therapy with iberdomide, plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome, clinically significant amyloidosis

ΝΑΙ

I/II

IberDd Versus DVd

Ιαν-24

Ιουν-26

Labropoulou

53

BMS

CA056-025

MDS

ESA naive, NTD,  very low-low-intermediate risk

secondary MDS, known history of diagnosis of AML, PRCA, history of DVT-stroke-transient ischemic-cerebrovascular accident

ΝΑΙ

III (ROL)

Luspa vs Epo

Φεβ-24

30/9/2025

54

BMS

CA057-008

MM

R/R

prior treatment with mezigdomide or carfilzomib, prior allo-SCT

ΝΑΙ

III (ROL)

CC-92480+Kd vs Kd

Ιαν-24

Ιαν-25

Labropoulou

55

Takeda

ΤΑΚ-881-3001

PIDD

IgG >5G/dL, requiring immunoglobulin (IgG) replacement,

IgA deficiency, HIV, hepatitis, PLT<20.000, anemia,eGFR<60 ml/min

ΝΑΙ

I/II

TAK-881 (immunoglobulin, sc)

Φεβ-24

Δεκ-25

56

Beigene

BGB-3111-308

Follicular

grade 1-3a FL or MZL, Measurable disease (CT or MRI), at least 1L (anti-CD20)

Transformation to aggressive lymphoma, need for corticosteroid treatment

ΝΑΙ

III (ROL)

zanubrutinib+anti-CD20 vs Len+Rituximab

Μαρ-24

Ιουν-26

EΠΕΞΗΓΗΣΕΙΣ: RWE (Real World Evidence), ROL (Randomized Open Label), RDB (Randomized Double Blind), 2L (second line), 1L (first line), MD (Medical Doctor)

updated: 29 Sep 2023