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:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Inotuzumab Ozogamicin in Treating Patients With Relapsed or Refractory CD22 Positive Acute Lymphoblastic 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
  • SECONDARY ID: NCI-2018-01237
  • SECONDARY ID: 2015-0870
  • SECONDARY ID: P30CA016672
  • NCT ID: NCT03094611

Conditions

  • CD22 Positive
  • Recurrent Acute Lymphoblastic Leukemia
  • Refractory Acute Lymphoblastic Leukemia

Interventions

DrugSynonymsArms
Inotuzumab OzogamicinBesponsa, CMC-544, Way 207294, WAY-207294Treatment (inotuzumab ozogamicin)

Purpose

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.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To evaluate the objective response rate of low dose of inotuzumab ozogamicin as measured
      by the hematologic remission rate (complete remission [CR] + CR with incomplete platelet
      recovery [CRp] + CR with incomplete bone marrow recovery [CRi]) in patients in first, second
      or later salvage setting.

      SECONDARY OBJECTIVES:

      I. To evaluate the overall safety profile and the efficacy; the efficacy is measured by the
      hematologic response rate (CR + CRi + PR), durations of response (DoR) and remission (DoR1),
      progression free survival (PFS), and overall survival (OS).

      OUTLINE:

      Patients receive inotuzumab ozogamicin intravenously (IV) over 1 hour on days 1, 8 and 15 of
      cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6
      cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease
      gets worse after responding for 3 months, may be retreated for up to 6 additional cycles.
      Patients whose disease responds to treatment may receive up to 5 additional cycles.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (inotuzumab ozogamicin)ExperimentalPatients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 of cycle 1 and on days 1 and 8 beginning cycle 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients whose disease gets worse after responding for 3 months, may be retreated for up to 6 additional cycles. Patients whose disease responds to treatment may receive up to 5 additional cycles.
  • Inotuzumab Ozogamicin

Eligibility Criteria

        Inclusion Criteria:

          -  Patients at least 12 years of age

          -  Patients with a diagnosis of CD22-positive acute lymphoblastic leukemia (ALL) based on
             local immunophenotyping and histopathology who have:

               -  Refractory disease, defined as disease progression or no response while receiving
                  their most recent prior anti-cancer therapy,

               -  Relapsed disease, defined as response to their most recent prior anti-cancer
                  therapy with subsequent relapse

          -  Performance status of 0 to 3

          -  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

          -  Total serum bilirubin =< 1.5 x ULN unless the patient has documented Gilbert syndrome.
             If organ function abnormalities are considered due to tumor, total serum bilirubin
             must be =< 2 x ULN

          -  Aspartate and alanine aminotransferase (AST or ALT) =< 2.5 x ULN

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

          -  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)

          -  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:

          -  Pregnant or nursing women

          -  Known to be human immunodeficiency virus (HIV)+

          -  Philadelphia chromosome (Ph)+ ALL

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

          -  Unable or unwilling to sign the consent form

          -  Prior allogeneic stem cell transplantation (ASCT) or other anti-CD22 immunotherapy
             within =< 4 months before first dose of study treatment

          -  Active central nervous system (CNS) or extramedullary disease unless approved by the
             principal investigator (PI)

          -  Monoclonal antibodies therapy within 2 weeks before study entry

          -  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

          -  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:Objective response rate of low dose of inotuzumab ozogamicin
Time Frame:Up to 6 years
Safety Issue:
Description:Measured by the hematologic remission rate (complete remission [CR] + CR with incomplete platelet recovery + CR with incomplete bone marrow recovery [CRi]) in patients in first, second or later salvage setting.

Secondary Outcome Measures

Measure:Incidence of adverse events
Time Frame:Up to 6 years
Safety Issue:
Description:
Measure:Hematologic response rate (CR + CRi + partial response)
Time Frame:Up to 6 years
Safety Issue:
Description:
Measure:Duration of response
Time Frame:Up to 6 years
Safety Issue:
Description:
Measure:Duration of remission
Time Frame:Up to 6 years
Safety Issue:
Description:
Measure:Progression free survival
Time Frame:Up to 6 years
Safety Issue:
Description:
Measure:Overall survival
Time Frame:Up to 6 years
Safety Issue:
Description:

Details

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

Last Updated

April 2, 2020