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Trial record 3 of 25 for:    "Acute Lymphocytic Leukemia" | "inotuzumab ozogamicin"

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

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ClinicalTrials.gov Identifier: NCT03610438
Recruitment Status : Not yet recruiting
First Posted : August 1, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

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.


Condition or disease Intervention/treatment Phase
Acute Lymphoid Leukemia Drug: Inotuzumab Ozogamicin (IO) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022


Arm Intervention/treatment
Experimental: Cohort 1
Cohort 1 will entroll 38 Ph+ patients
Drug: 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.


Experimental: Cohort 2
Cohort 2 will enroll 38 Ph- patients
Drug: 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.




Primary Outcome Measures :
  1. Number of patients obtaining a negative Minimal Residual Disease (MRD) [ Time Frame: Two years after study entry. ]

Secondary Outcome Measures :
  1. Number of patients alive [ Time Frame: Two years from start of treatment. ]
  2. Number of adverse events in MRD positive patients [ Time Frame: Two years after study entry. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610438


Contacts
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Contact: Paola Fazi +39 06 70390514 p.fazi@gimema.it
Contact: Enrico Crea +39 06 70390514 e.crea@gimema.it

Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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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

Additional Information:
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT03610438     History of Changes
Other Study ID Numbers: ALL2418
2018-003006-32 ( EudraCT Number )
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Acute Lymphoid Leukemia
Inotuzumab Ozogamicin
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Inotuzumab Ozogamicin
Burkitt Lymphoma
Leukemia
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Antineoplastic Agents