Feasibility and Effectiveness of Inotuzumab Ozogamicin in B-Cell Acute Lymphoblastic Leukemia
NCT ID: NCT03610438
Last Updated: 2022-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
76 participants
INTERVENTIONAL
2019-10-30
2022-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Inotuzumab Ozogamicin and Conventional Chemotherapy In Patients Aged 56 Years and Older With ALL
NCT03460522
Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia
NCT06427330
Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma
NCT05303792
Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia
NCT03104491
Effectiveness and Safety of InO±DLI for Relapsed B-ALL/LBL After Allo-HSCT
NCT06861348
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
Cohort 1 will entroll 38 Ph+ patients
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.
Cohort 2
Cohort 2 will enroll 38 Ph- patients
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Giovanni Martinelli
Role: STUDY_CHAIR
Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST Italy
Fabio Ciceri
Role: STUDY_DIRECTOR
Istituto S. Raffaele, Milan, Italy Giuseppe Saglio, Institute of Hematology, Ospedale Mauriziano, Turin, Italy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Olivieri
Role: primary
Mosna
Role: primary
Lemoli
Role: primary
Di Renzo
Role: primary
Cangini
Role: primary
Todisco
Role: primary
Mulè
Role: primary
Zappasodi
Role: primary
Spadano
Role: primary
Mianulli
Role: primary
De Fabritiis
Role: primary
Chiaretti
Role: primary
Selleri
Role: primary
Bocchia
Role: primary
Audisio
Role: primary
Endri
Role: primary
Candoni
Role: primary
Bonifacio
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
GIMEMA Foundation website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-003006-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALL2418
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.