Feasibility and Effectiveness of Inotuzumab Ozogamicin in B-Cell Acute Lymphoblastic Leukemia
ALL2418
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
2 other identifiers
interventional
76
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2019
Typical duration for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2018
CompletedFirst Posted
Study publicly available on registry
August 1, 2018
CompletedStudy Start
First participant enrolled
October 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedJanuary 4, 2022
December 1, 2021
3 years
July 25, 2018
December 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients obtaining a negative Minimal Residual Disease (MRD)
Two years after study entry.
Secondary Outcomes (2)
Number of patients alive
Two years from start of treatment.
Number of adverse events in MRD positive patients
Two years after study entry.
Study Arms (2)
Cohort 1
EXPERIMENTALCohort 1 will entroll 38 Ph+ patients
Cohort 2
EXPERIMENTALCohort 2 will enroll 38 Ph- patients
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giovanni Martinelli
Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST Italy
- STUDY DIRECTOR
Fabio Ciceri
Istituto S. Raffaele, Milan, Italy Giuseppe Saglio, Institute of Hematology, Ospedale Mauriziano, Turin, Italy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2018
First Posted
August 1, 2018
Study Start
October 30, 2019
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
January 4, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share