Clinical Trials /

Inotuzumab Ozogamicin in Treating Patients With Relapsed or Refractory CD22 Positive Acute Lymphoblastic Leukemia

NCT03094611

Description:

This phase II trial studies how well inotuzumab ozogamicin works in treating patients with CD22 positive acute lymphoblastic leukemia that has come back or does not respond to treatment. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them.

Related Conditions:
  • Acute Lymphoblastic Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Low Dose Inotuzumab Ozogamicin in Patients With Relapsed and Refractory CD22 Positive Acute Lymphocytic Leukemia
  • Official Title: Phase II Study of Low Dose Inotuzumab Ozogamicin in Patients With Relapsed and Refractory CD22 Positive Acute Lymphocytic Leukemia

Clinical Trial IDs

  • ORG STUDY ID: 2015-0870
  • NCT ID: NCT03094611

Conditions

  • Acute Lymphocytic Leukemia

Interventions

DrugSynonymsArms
Inotuzumab ozogamicinCMC-544Inotuzumab Ozogamicin

Purpose

The goal of this clinical research study is to learn if inotuzumab ozogamycin can help to control the disease in participants with acute lymphocytic leukemia (ALL). The safety of this treatment will also be studied.

Detailed Description

      Study Drug Administration:

      There are 28 (+/- 7) days in each cycle.

      If participant is found to be eligible to take part in this study, participant will receive
      the study drug by vein over about 1 hour on Days 1, 8, and 15 of each cycle.

      If participant's doctor thinks it is needed, participant may also receive drugs through a
      spinal tap (intrathecally) to help lower the risk of the disease coming back in the fluid
      surrounding participant's brain.

      Participant may be given other drugs to help decrease the risk of side effects.
      Participant's doctor will tell participant about these drugs, how they will be given, and
      the possible risks.

      Length of Treatment:

      Participant may receive up to 6 cycles of treatment. Participant will no longer be able to
      take the study drugs if the disease gets worse, if intolerable side effects occur, or if
      participant is unable to follow study directions.

      If the disease gets worse after responding for at least 3 months, participant may be able to
      be retreated for up to 6 additional cycles. Participant will continue to have study visits
      as described above. The study doctor will discuss this option with participant. Participant
      is still at risk for side effects due to the study drug. This could also delay starting
      other treatments. The disease may also get worse to the point that participant is no longer
      able to receive other treatments.

      Study Visits:

      Before each treatment cycle, participant will have a physical exam.

      One (1) time weekly during Cycles 1-6, blood (about 2-3 tablespoons) will be drawn for
      routine tests.

      On Days 14 and 21 of Cycle 1, then every 2-3 cycles, participant will have a bone marrow
      biopsy and/or aspiration.

      This is an investigational study. Inotuzumab ozogamycin is not FDA approved or commercially
      available. It is currently being used for research purposes only.

      Up to 48 participants will take part in this study. All will be enrolled at MD Anderson.
    

Trial Arms

NameTypeDescriptionInterventions
Inotuzumab OzogamicinExperimentalParticipants receive Inotuzumab Ozogamicin at the dose of 0.8 mg/m2 on Day 1, and 0.5 mg/m2 on Days 8 and 15 of cycle 1. Subsequent cycles consist of Inotuzumab Ozogamicin at the dose of 0.6 mg/m2 on Day 1 and 0.3 mg/m2 on Day 8. A maximum of 6 cycles administered. Cycles are 28 days.
  • Inotuzumab ozogamicin

Eligibility Criteria

        Inclusion Criteria:

          1. Patients at least 12 years of age.

          2. Patients with a diagnosis of CD22-positive ALL (ie, >/=10% blasts CD22-positive)
             based on local immunophenotyping and histopathology) who have: a.Refractory disease,
             defined as disease progression or no response while receiving their most recent prior
             anti-cancer therapy., b.Relapsed disease, defined as response to their most recent
             prior anti-cancer therapy with subsequent relapse.

          3. Performance status of 0 to 3.

          4. Adequate renal function including serum creatinine </= 2 x upper limit of normal
             (ULN) or estimated creatinine clearance >/= 15 mL/min as calculated using the method
             standard for the institution.

          5. Adequate liver function, including total serum bilirubin </= 1.5 x ULN unless the
             patient has documented Gilbert syndrome, and aspartate and alanine aminotransferase
             (AST or ALT) </= 2.5 x ULN. If organ function abnormalities are considered due to
             tumor, total serum bilirubin must be </= 2 x ULN

          6. No active or co-existing malignancy requiring chemotherapy or radiation within 6
             months.

          7. Female subjects of childbearing potential should be willing to use effective methods
             birth control or be surgically sterile, or abstain from heterosexual activity for the
             course of the study. Subjects of childbearing potential are those who have not been
             surgically sterilized or have not been free from menses for > 1 year. Effective
             methods of birth control include birth control pills or injections, intrauterine
             devices (IUDs), or double-barrier methods (for example, a condom in combination with
             spermicide).

          8. Male subjects should agree to use an effective method of contraception starting with
             the first dose of study therapy through the duration of treatment.

        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 (ASCT) or other anti-CD22 immunotherapy
             within </= 4 months before first dose of study treatment.

          7. Active CNS or extramedullary disease unless approved by the PI.

          8. Monoclonal antibodies therapy within 2 weeks before study entry

          9. Radiotherapy and cancer chemotherapy (except for intrathecal chemotherapy,
             hydroxyurea, and cytarabine. Cytarabine and hydroxyurea are allowed to be used
             emergently in case of leukocytosis) or any investigational drug within 2 weeks before
             study entry.

         10. Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction
             syndrome (SOS)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Hematologic Remission
Time Frame:168 days
Safety Issue:
Description:Hematologic remission defined as complete remission (CR) + complete remission without platelet recovery (CRp) + complete remission with incomplete count recovery (CRi) occurring any time during the treatment.

Secondary Outcome Measures

Measure:Toxicities of Low Dose Inotuzumab Ozogamicin according to the NCI CTCAE v4.0
Time Frame:168 days
Safety Issue:
Description:Toxicities graded according to the NCI CTCAE v4.0.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Trial Keywords

  • Acute lymphocytic leukemia
  • ALL
  • CD22-positive
  • Inotuzumab Ozogamicin
  • CMC-544

Last Updated

April 19, 2017