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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03610438
Other study ID # ALL2418
Secondary ID 2018-003006-32
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 30, 2019
Est. completion date November 2022

Study information

Verified date December 2021
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact Paola Fazi
Phone +39 06 70390514
Email p.fazi@gimema.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 76
Est. completion date November 2022
Est. primary completion date November 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Italy 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 Milano
Italy Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia Milano
Italy Istituto Europeo Di Oncologia Irccs - Milano - Divisione Di Oncoematologia Milano
Italy Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo Napoli
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

Sponsors (1)

Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients obtaining a negative Minimal Residual Disease (MRD) Two years after study entry.
Secondary Number of patients alive Two years from start of treatment.
Secondary Number of adverse events in MRD positive patients Two years after study entry.
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