Clinical Trials /

Inotuzumab Ozogamicin in Treating Participants With B-cell Acute Lymphocytic Leukemia With Positive Minimal Residual Disease

NCT03441061

Description:

This phase II trial studies how well inotuzumab ozogamicin works in treating participants with B-cell acute lymphocytic leukemia with positive minimal residual disease. Inotuzumab ozogamicin is a monoclonal antibody called inotuzumab linked to a toxic agent called ozogamicin. Inotuzumab ozogamicin attaches to B cell-specific CD22 cancer cells in a targeted way and kills them.

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Inotuzumab Ozogamicin in Patients With B-cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease
  • Official Title: Phase II Study of Inotuzumab Ozogamicin in Patients With B-cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease

Clinical Trial IDs

  • ORG STUDY ID: 2015-0921
  • NCT ID: NCT03441061

Conditions

  • Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic
  • Acute Lymphocytic Leukemia

Interventions

DrugSynonymsArms
Inotuzumab OzogamicinCMC-544Inotuzumab Ozogamicin

Purpose

The goal of this clinical research study is to learn how well low-dose inotuzumab ozogamicin may help to control acute lymphocytic leukemia (ALL). The safety of the study drug will also be studied. This is an investigational study. Inotuzumab ozogamicin is FDA approved and commercially available for the treatment of ALL. The study doctor can explain how the study drug is designed to work. Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.

Detailed Description

      Study Drug Administration:

      Each cycle is 28 (+/- 7) days.

      If participant is found to be eligible to take part in this study, participant will receive
      inotuzumab ozogamicin by vein over about 1 hour on Days 1, 8, and 15 of Cycle 1 and Days 1
      and 8 of Cycles 2-6.

      Participant may be given standard drugs to help prevent side effects. If participant's doctor
      thinks it is needed, participant may also receive standard drugs by a spinal tap
      (intrathecally) to help lower the risk of the disease coming back in the fluid surrounding
      participant's brain. Participant's doctor will tell participant about these drugs, how they
      will be given, and the possible risks.

      Length of Treatment:

      Participant may receive the study drug for up to 6 cycles. However, if participant's doctor
      thinks it is in participant's best interest to receive a stem cell transplant from a donor,
      participant will only receive 2-3 cycles.

      Participant may be taken off study after Cycle 2 if the disease has had no response. However,
      if the treating doctor and study doctor decide it is in participant's best interest,
      participant may be able to receive up to 2 more cycles after that.

      If there is no sign of cancer for 3 months but then small numbers of cancer cells come back,
      participant may be eligible for retreatment again on the same schedule of study drug doses.
      The study doctor will discuss this with participant.

      Participant will no longer be able to take the study drug if the disease gets worse, if
      intolerable side effects occur, or if participant is unable to follow study directions.

      Participation on the study will be over after the Cycle 6 visit.

      Study Visits:

      On Day 1 of Cycles 1-6:

        -  Participant will have a physical exam.

        -  Blood (about 2-3 tablespoons) will be drawn for routine tests.

      At Weeks 2, 3, and 4 of Cycles 1-6, blood (about 2-3 tablespoons) will be drawn for routine
      tests.

      On Day 21 of Cycle 1 and then at the end of Cycles 2-6, participant will have a bone marrow
      biopsy and/or aspiration to check the status of the disease.
    

Trial Arms

NameTypeDescriptionInterventions
Inotuzumab OzogamicinExperimentalParticipants receive Inotuzumab Ozogamicin by vein over about 1 hour on Days 1, 8, and 15 of Cycle 1 and Days 1 and 8 of Cycles 2-6. Each cycle is 28 (+/- 7) days.
  • Inotuzumab Ozogamicin

Eligibility Criteria

        Inclusion Criteria:

          1. Patients at least 18 years of age.

          2. Patients with B-lineage ALL in hematologic complete remission (CR) with molecular
             failure (ie, had never achieved an MRD-negativity status before inotuzumab ozogamicin)
             or had a molecular relapse (ie, became MRD positive after having been MRD negative)
             starting at any time point after 3 months of frontline therapy. Molecular disease or
             minimal residual disease is defined by a value of at least of 10^-4 by multicolor flow
             cytometry.

          3. Patients with B-lineage ALL in CR2 and beyond with molecular failure at any time point
             after 2 months of salvage therapy are allowed

          4. Performance status of 0, 1, or 2

          5. Adequate organ function with creatinine clearance >/=15 ml/min and bilirubin <1.5 X
             ULN and AST or ALT <2X ULN.

          6. No active or co-existing malignancy with life expectancy less than 12 months.

        Exclusion Criteria:

          1. Pregnant or nursing women

          2. Known to be HIV+

          3. Ph+ ALL

          4. Active and uncontrolled disease/infection as judged by the treating physician

          5. Unable or unwilling to sign the consent form

          6. Prior allogeneic stem cell transplantation

          7. Active CNS or extramedullary disease

          8. Monoclonal antibodies therapy within 2 weeks before study entry

          9. Radiotherapy or cancer chemotherapy (except for intrathecal prophylaxis and/or
             low-dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate,
             steroids) or any investigational drug within 2 weeks before study entry
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Relapse-Free Survival of Inotuzumab Ozogamicin in Patients With B-cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease
Time Frame:Day 28 up to 6 months
Safety Issue:
Description:Relapse-free survival defined as the time interval from date of treatment start until the date of death or hematologic or extramedullary disease relapse.

Secondary Outcome Measures

Measure:Toxicities of Inotuzumab Ozogamicin in Patients With B-cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease
Time Frame:Day 28 up to 6 months
Safety Issue:
Description:Toxicities defined as any treatment -related grade 3 or 4 non-hematologic AEs occurred any time during the trial.
Measure:Minimal Residual Disease (MRD) of Inotuzumab Ozogamicin in Patients With B-cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease
Time Frame:Day 28 up to 6 months
Safety Issue:
Description:Bone marrow biopsy and/or aspiration to check the status of the disease.
Measure:Overall Survival of Inotuzumab Ozogamicin in Patients With B-cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease
Time Frame:Day 28 up to 6 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Trial Keywords

  • Malignant neoplasms stated as primary lymphoid haematopoietic
  • Acute Lymphocytic Leukemia
  • ALL
  • Inotuzumab Ozogamicin
  • CMC-544

Last Updated

February 15, 2018