Feasibility and Effectiveness of Inotuzumab Ozogamicin in B-Cell Acute Lymphoblastic Leukemia (ALL2418)

  • STATUS
    Recruiting
  • End date
    Nov 25, 2022
  • participants needed
    76
  • sponsor
    Gruppo Italiano Malattie EMatologiche dell'Adulto
Updated on 25 March 2022
lymphoid leukemia
cell transplantation
minimal residual disease
b-cell acute lymphoblastic leukemia
residual tumor
inotuzumab

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.

Details
Condition Acute Lymphoid Leukemia
Treatment Inotuzumab Ozogamicin (IO)
Clinical Study IdentifierNCT03610438
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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
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