Clinical Trials /

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

NCT03610438

Description:

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.

Related Conditions:
  • B-Cell Acute Lymphoblastic Leukemia
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Feasibility and Effectiveness of Inotuzumab Ozogamicin in B-Cell Acute Lymphoblastic Leukemia
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: ALL2418
  • SECONDARY ID: 2018-003006-32
  • NCT ID: NCT03610438

Conditions

  • Acute Lymphoid Leukemia

Interventions

DrugSynonymsArms
Inotuzumab Ozogamicin (IO)Cohort 1
Inotuzumab Ozogamicin (IO)Cohort 2

Purpose

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 Arms

NameTypeDescriptionInterventions
Cohort 1ExperimentalCohort 1 will entroll 38 Ph+ patients
  • Inotuzumab Ozogamicin (IO)
Cohort 2ExperimentalCohort 2 will enroll 38 Ph- patients
  • Inotuzumab Ozogamicin (IO)

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients obtaining a negative Minimal Residual Disease (MRD)
Time Frame:Two years after study entry.
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of patients alive
Time Frame:Two years from start of treatment.
Safety Issue:
Description:
Measure:Number of adverse events in MRD positive patients
Time Frame:Two years after study entry.
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Gruppo Italiano Malattie EMatologiche dell'Adulto

Trial Keywords

  • Acute Lymphoid Leukemia
  • Inotuzumab Ozogamicin

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