QOL-ONE Phoenix

MDS del5q  low-intermediate IPSS R

Contatti: P.I. Elena Crisà Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.  - Sudy Coordinator Sara Donè Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.

Linea terapeutica: Refractory or intollerant to lenalidomide

Coorti: Single ARM Phase 2

Terapia: Luspatercept

Inclusion:

  • Documented diagnosis of MDS with del5q according to 2018 WHO classification
  • IPSS-R classification (Greenberg, 2012) of very low, low, or intermediate risk disease, and: < 5% blasts in bone marrow and Peripheral blood WBC count <13,000/μL
  • Refractory or intolerant to, or ineligible for, prior ESA treatment
  • Refractory or intolerant to, or ineligible for, prior lenalidomide treatment

Exclusion:

  • Previously treated with either luspatercept (ACE-536) or sotatercept (ACE-011)
  • Secondary MDS, ie, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases.
  • Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
  • Prior allogeneic or autologous stem cell transplant

 

REMARK

MDS low-intermediate IPSS R with anemia TD or non TD

Contatti: P.I. Elena Crisà Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.  - Sudy Coordinator Sara Donè Questo indirizzo email è protetto dagli spambots. È necessario abilitare JavaScript per vederlo.

Linea terapeutica: or not candidate to prior ESA treatment /luspatercept/lenalidomide

Coorti: Single ARM Phase 2

Terapia: RVU120

Inclusion:

  • Very low, low or intermediate risk disease MDS with up to 3.5 points according to International
  • Prognostic Scoring System Score Revised (IPSS-R) classification (to be confirmed during screening assessment).
  • Patients with del(5q) and max. one further abnormality (excluding monosomy 7, del(7q), TP53mut) are eligible.
  • No available option of an approved MDS therapy according to decision of the treating physician and based on the following:
  • Patients must be ESA exposed (and refractory or intolerant) or ESA naïve and serum erythropoietin level >200 U/L  
    AND/OR
    Luspatercept exposed (and refractory or intolerant) or luspatercept naïve and not eligible for treatment (e.g. not approved)
    AND/OR
    Lenalidomide exposed (and refractory or intolerant) or lenalidomide naïve and not eligible for treatment (e.g. due to non-presence of del(5q))

Exclusion:

  • Patient does not accept bone marrow sampling during screening and after the treatment.
  • Prior treatment with azacitidine (injectable or oral) or decitabine.
  • Iron chelation therapy

 

IRSTB082 – immune AML

Studio dell’immunogenicità e degli effetti immunologici degli agenti ipometilanti nella leucemia mieloide acuta

 

ARO-013

Phase III randomized, double-blind, placebo-controlled study investigating the efficacy of the addition of Crenolanib to salvage chemotherapy alone in subjects ≤ 75 years of age with relapsed/refractory FLT3 mutated acute myeloid leukemia

 

AML1819

Phase III study to assess the impact of Gemtuzumab Ozogamicin, in combination with standard chemotherapy, on the levels of minimal residual disease, and the role of Glasdegib as a post-transplant maintenance, in adult patients, aged 18-60 years, with previously untreated, de novo, favorable-intermediate-risk acute myeloid leukemia

 

Abbvie PMOS-VERO

VEnetoclax Real-World Observational study on effectivenes and treatment management in patients with newly diagnosed AML who are ineligible for intensive chemotherapy in Italy (VERO)

GIMEMA LAL2418

Studio di fase IIA sulla fattibilità e l’efficacia di Inotuzumab Ozogamicin (IO) in pazienti adulti con Leucemia Linfoblastica Acuta a cellule B con Malattia Minima Residua positiva prima di un trapianto di cellule staminali ematopoietiche

 

GIMEMA LAL2922

Combinazione di Ponatinib e chemioterapia come trattamento di prima linea per i pazienti con leucemia acuta linfoblastica BCR/ABL1-like (LAL BCR/ABL1-like) – BALLik

 

GIMEMA LAL2820

Leucemia acuta linfoblastica Philadelphia-positiva dell’adulto alla diagnosi. Trattamento sequenziale con il ponatinib e l’anticorpo monoclonale bispecifico blinatumomab vs chemioterapia e imatinib

 

GIMEMA LAL2620

Ponatinib for for the management of minimal residual disease (MDR) and hematological relapse in adult Ph+ acute lymphoblastic leukemia (PH+ALL) patients

 

GIMEMA LAL2720

Advancing chemical and genomic strategies for relapsed/refractory T-ALL and ETP-ALL