Feasibility and Effectiveness of Inotuzumab Ozogamicin in B-Cell Acute Lymphoblastic Leukemia
- Conditions
- Acute Lymphoid Leukemia
- Interventions
- Drug: Inotuzumab Ozogamicin (IO)
- Registration Number
- NCT03610438
- Brief Summary
This is a multi-center, phase 2A exploratory study of feasibility and effectiveness of Inotuzumab Ozagomicin in adult patients with Acute Lymphoid Leukemia (ALL) with positive minimal residual disease before any hematopoietic stem cell transplantation.
The study is divided in two cohorts; cohort 1 will enroll 38 Ph+ patients, cohort 2 will enroll 38 Ph- patients, as defined with statistical analysis. The two cohorts will have the same treatment, with the exception of short term and long term maintenance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 76
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 Inotuzumab Ozogamicin (IO) Cohort 1 will entroll 38 Ph+ patients Cohort 2 Inotuzumab Ozogamicin (IO) Cohort 2 will enroll 38 Ph- patients
- Primary Outcome Measures
Name Time Method Number of patients obtaining a negative Minimal Residual Disease (MRD) Two years after study entry.
- Secondary Outcome Measures
Name Time Method Number of adverse events in MRD positive patients Two years after study entry. Number of patients alive Two years from start of treatment.
Trial Locations
- Locations (30)
I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica
🇮🇹Meldola, Italy
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
🇮🇹Milano, Italy
Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia
🇮🇹Milano, Italy
Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia
🇮🇹Reggio Calabria, Italy
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
🇮🇹Bologna, Italy
Aso S. Croce E Carle - Cuneo - Sc Ematologia
🇮🇹Cuneo, Italy
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
🇮🇹Lecce, Italy
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
🇮🇹Brescia, Italy
Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia
🇮🇹Mestre, Italy
Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo
🇮🇹Napoli, Italy
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
🇮🇹Verona, Italy
Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia
🇮🇹Milano, Italy
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
🇮🇹Palermo, Italy
Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia
🇮🇹Pavia, Italy
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
🇮🇹Rimini, Italy
Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia
🇮🇹Roma, Italy
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
🇮🇹Roma, Italy
Aou "San Giovanni Di Dio E Ruggi D'Aragona" - Salerno - Uoc Ematologia E Trapianti Di Cellule Staminali Emopoietiche
🇮🇹Salerno, Italy
Aou Senese - Uoc Ematologia E Trapianti
🇮🇹Siena, Italy
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
🇮🇹Torino, Italy
Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana
🇮🇹Treviso, Italy
Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
🇮🇹Udine, Italy
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
🇮🇹Vicenza, Italy
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona- Sod Clinica Ematologica
🇮🇹Ancona, Italy
Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia
🇮🇹Bergamo, Italy
Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
🇮🇹Ascoli Piceno, Italy
As Dell'Alto Adige, Ospedale Centrale Di Bolzano - Ematologia E Centro Trapianto Midollo Osseo
🇮🇹Bolzano, Italy
Irccs Aou San Martino - Genova - Uo Clinica Ematologica
🇮🇹Genova, Italy
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
🇮🇹Pescara, Italy
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
🇮🇹San Giovanni Rotondo, Italy