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NCT03610438

PHASE2

Feasibility and Effectiveness of Inotuzumab Ozogamicin in B-Cell Acute Lymphoblastic Leukemia

Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2019-10-30

Completion Date

2026-10

Last Updated

2026-07-16

Healthy Volunteers

Conditions

Acute Lymphoid Leukemia

Interventions

DRUG

Inotuzumab Ozogamicin (IO)

After course 1 MRD will be evaluated: \- patients MRD negative will enter into short maintenance or long maintenance according to investigator choice. After 4 to 12 weeks in short maintenance patient will undergo SCT, otherwise, patients will enter long maintenance.

DRUG

Inotuzumab Ozogamicin (IO)

After course 2 MRD will be evaluated; patients MRD negative will enter into short maintenance or long maintenance by investigator choice. After 4 to 12 weeks in short maintenance patient will undergo SCT, otherwise, patients will enter long maintenance.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (30)

Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona- Sod Clinica Ematologica

Ancona, 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

Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia

Bergamo, Italy

Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia

Bologna, Italy

As Dell'Alto Adige, Ospedale Centrale Di Bolzano - Ematologia E Centro Trapianto Midollo Osseo

Bolzano, Italy

Asst Degli Spedali Civili Di Brescia - Uo Ematologia

Brescia, Italy

Aso S. Croce E Carle - Cuneo - Sc Ematologia

Cuneo, Italy

Irccs Aou San Martino - Genova - Uo Clinica Ematologica

Genova, Italy

Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia

Lecce, Italy

I.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica

Meldola, Italy

Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia

Mestre, Italy

Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia

Milan, Italy

Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia

Milan, Italy

Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia

Milan, Italy

Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo

Naples, Italy

Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo

Palermo, Italy

Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia

Pavia, Italy

Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica

Pescara, Italy

Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli" Po E. Morelli - Reggio Calabria - Uoc Ematologia

Reggio Calabria, 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

Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia

San Giovanni Rotondo, 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

Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia

Verona, Italy

Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia

Vicenza, Italy

Clinical Research Directory

Feasibility and Effectiveness of Inotuzumab Ozogamicin in B-Cell Acute Lymphoblastic Leukemia

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (30)