ALL2418 - A Phase IIA Study of Feasibility and Effectiveness of Inotuzumab Ozogamicin (IO) in Adult Patients With B-Cell Acute Lymphoblastic Leukemia With Positive Minimal Residual Disease Before Any Hematopoietic Stem Cell Transplantation

Studio Clinico

Patologia: Neoplasie ematologiche

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- Ph+ ALL with p190 or p210 detectable and measurable (at least 10-4 x10000 ABL) after at least 3 months of any therapy, or the failure of at least 2 TKI.
- Ph- ALL with detectable and measurable IG specific transcript after at least 2 courses of previous therapy.
- Age ≥ 18 years old.
- ECOG ≤ 2.

Criteri di esclusione: 

- More than 5% of BM blasts.
- WHO performance status ≤ 50% (Karnofsky) or ≥ 3 (ECOG).
- Active HBV or HCV hepatitis, or AST/ALT ≥ 2.5 x ULN and bilirubine ≥ 1.5 x ULN.
- Evidence of liver fibrosis, portal hypertension or other clinically relevant liver abnormalities at screening liver ultrasonography.
- History of alcohol abuse.
- Burkitt lymphoma and active CNS leukemia. Patients with previuos neurological toxicitiy as well co-morbidity will be carefully evaluated for enrolment.
- Ongoing or active infections.
- Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL). Clinically significant, uncontrolled, or active cardiovascular disease.
- Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control.
- Creatinine level > 2.5mg/dl or Glomerular Filtration Rate (GFR) < 20 ml/min or proteinuria > 3.5 g/day.
- Documented inherited protrombotic disorders
- Patients who have received any investigational drug ≤ 4 weeks.
- Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention or with a life expectancy due to other malignancy <6 months.
- Patients that have received Inotuzumab or Anti CD22 directed therapies before
- Patients with known hereditary coagulopathy
- Patient that received during their life diagnosis of VOD or had ongoing VOD
- Patients who are pregnant or breastfeeding and adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of induction therapy). Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 4 months following discontinuation of study drugs.
- Patients unwilling or unable to comply with the protocol.

Trattamento sperimentale: 

Inotuzumab Ozogamicin (IO)

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Number of patients obtaining a negative Minimal Residual Disease (MRD) [ Time Frame: Two years after study entry. ]

Obiettivi secondari dello studio: 

- Number of patients alive [ Time Frame: Two years from start of treatment. ]
- Number of adverse events in MRD positive patients [ Time Frame: Two years after study entry. ]

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2018-003006-32

Data di inserimento: 22.09.2022

Promotore

Gruppo Italiano Malattie EMatologiche dell'Adulto 

Principal Investigator ITALIA

Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' - IRST IRCCS, Meldola (FC

Riferimento: Prof. Giovanni Martinelli

Telefono: 0543739100

Email: giovanni.martinelli@irst.emr.it

Localita: Meldola (FC)