Ireland
--:--IST
Latest
Active, not recruiting Phase 2

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

NCT03610438 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2019-10-30
Last updated
2026-07-16

Condition(s) studied

Acute Lymphoid Leukemia

Investigational drug(s) / intervention(s)

Inotuzumab Ozogamicin (IO) →Inotuzumab Ozogamicin (IO) →

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of patients obtaining a negative Minimal Residual Disease (MRD) — Two years after study entry.

Trial sites (30)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03610438 on ClinicalTrials.gov ↗ ← All trials in Italy