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.
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
Interventions
Drug | Synonyms | Arms |
---|
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
Name | Type | Description | Interventions |
---|
Cohort 1 | Experimental | Cohort 1 will entroll 38 Ph+ patients | - Inotuzumab Ozogamicin (IO)
|
Cohort 2 | Experimental | Cohort 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: | Recruiting |
Lead Sponsor: | Gruppo Italiano Malattie EMatologiche dell'Adulto |
Trial Keywords
- Acute Lymphoid Leukemia
- Inotuzumab Ozogamicin
Last Updated
June 5, 2020