CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)

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Brief Title

CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)

Official Title

Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) With CMC-544 (Inotuzumab Ozogamycin), With or Without Later Addition of Rituximab

Brief Summary

      The goal of this clinical research study is to learn if CMC-544 given alone, and possibly
      given in combination with rituximab, can help to control the disease in patients with ALL.
      The safety of the study drug(s) will also be studied.
    

Detailed Description

      Study Drugs:

      CMC-544 is a monoclonal antibody (a substance that can locate and bind to cancer cells). It
      is designed to attach to C22, a molecule that is found on most cancer cells with ALL. This
      may cause the cancer cells to die.

      Rituximab is a monoclonal antibody that is designed to attach to leukemia cells and activate
      a series of events that may cause the cancer cells to die.

      Study Drug Administration:

      If you are found to be eligible to take part in this study, you will receive CMC-544 by vein
      over about 60 minutes on Day 1 of each study "cycle" or over 60 minutes at a lowered dose on
      Days 1, 8 and 15 of each cycle, depending on when you joined the study. No matter what dosing
      schedule you are on, you will receive the same total dosage of CMC-544. Each study cycle is
      about 3-4 weeks.

      If the disease is not responding to the CMC-544 after 2 cycles, you will begin receiving
      rituximab. On Day 1 of Cycle 3, you will receive rituximab by vein over about 8 hours. On Day
      2 of Cycle 3, you will receive CMC-544 alone by vein over about 60 minutes. Then, starting on
      Day 1 of Cycle 4, you will begin receiving rituximab by vein over about 8 hours and CMC-544
      by vein over about 60 minutes at least 2-4 hours after you receive the rituximab. You will
      receive this combination 1 time every week.

      Your dose of the study drug(s) may change depending on any side effects you may have.

      Study Visits:

      You will have study visits within 1 week before Day 1 of each study cycle. At each study
      visit, the following tests and procedures will be performed:

        -  You will have a physical exam.

        -  Your performance status will be recorded.

        -  You will be asked how you are feeling and about any drugs you may be taking.

        -  You will have an ECG before you receive treatment with CMC-544 (+ 2 days).

        -  Blood (about 1 tablespoon) may be drawn to test how the study drug(s) may affect cancer
           cells before you receive the CMC-544 infusion.

        -  If you are receiving rituximab and if you have a history of irregular heartbeat or chest
           pain (due to heart trouble), you will have ECGs performed before the start of the
           rituximab, once during the infusion, and within 2 hours after the infusion. Rituximab
           infusion will be stopped if you experience any serious episodes of irregular heartbeat.

        -  If you are receiving rituximab, you may be examined for any signs or symptoms of bowel
           obstruction (blockage) and/or perforation (hole in the intestines, which may cause the
           contents to leak). Appropriate radiologic tests and surgical consults will be performed
           as needed.

      Blood (about 1 tablespoon each time) will be drawn 1-3 times each week during Cycles 1 and 2,
      and at least 1 time every week during all other cycles for routine tests. Your doctor may
      decide to have more than 3 blood draws during Cycles 1 and 2.

      You will have a bone marrow aspirate and/or biopsy between Days 14-21 (+/- 3 days) of Cycle 1
      then every 1-2 cycles to check the status of the disease. You may have additional bone marrow
      aspirates and/or biopsies if your doctor feels it is necessary.

      Length of Study:

      You may receive CMC 544 with or without rituximab for up to 12 months. You will be taken off
      study if the disease gets worse or if you have intolerable side effects

      Follow-up Visits:

      You will have a follow-up visit 30 days after your last dose of the study drug(s). At this
      visit, you will be asked about any side effects you may be having. If you cannot make it to
      the clinic for this visit, it can be done over the phone with a member of the study staff.
      The phone call should last about 10 minutes.

      This is an investigational study. Rituximab is FDA approved and commercially available for
      the treatment of lymphoid cancer. Neither CMC-544 nor the CMC-544/rituximab combination are
      FDA approved or commercially available. Their use in this study is investigational.

      Up to 90 patients will take part in this study. All will be enrolled at MD Anderson.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of Patients With Response


Condition

Acute Lymphoblastic Leukemia

Intervention

CMC-544 (Inotuzumab Ozogamycin)

Study Arms / Comparison Groups

 Period 1: CMC-544 (Inotuzumab Ozogamycin) 1.3mg/m^2
Description:  First patients > 16 years and < 16 years receive CMC-544 (Inotuzumab Ozogamycin) at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

90

Start Date

June 4, 2010

Completion Date

April 18, 2018

Primary Completion Date

April 18, 2018

Eligibility Criteria

        Inclusion Criteria:

          1. Previously treated ALL (including Burkitt's lymphoma and lymphoblastic lymphoma) in
             relapse or primary refractory. Patients in first relapse will be eligible regardless
             of the first remission duration. At least 10 patients in Salvage 1-2 will be treated
             to assess anti-ALL response more precisely.

          2. Age 16 years or older. Pediatric patients (<16 years old) will be allowed into the
             study after safety is established, that is at least 10 adult patients having received
             1 or more cycles each.

          3. Zubrod performance status 0-3.

          4. Adequate liver function (bilirubin /= 1 year postmenopausal or surgically sterilized).

        Exclusion Criteria:

          1. Patient with active heart disease (NYHA class >/= 3 as assessed by history and
             physical examination).

          2. Patients with a cardiac ejection fraction (as measured by either Radionuclide
             angiography (MUGA) or echocardiogram) < 45% are excluded.

          3. Patients who receive other chemotherapy. Patients must have been off previous therapy
             for >/= 2 weeks and must have recovered from acute toxicity (to grade 1 or less) of
             all previous therapy prior to enrollment (consent signing). (Concurrent therapy for
             central nervous system [CNS] prophylaxis or treatment for CNS relapse is permitted).
             Treatment may start earlier if necessitated by the patient's medical condition (e.g.
             rapidly progressive disease) following discussion with the Principal Investigator.

          4. Prior allogeneic stem cell transplant in previous 4 months.

          5. Peripheral lymphoblasts > 50 x 10^9/L.

          6. Pregnant and breast-feeding patients are excluded.

          7. Patients with known hepatitis B are excluded.
      

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Hagop Kantarjian, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01134575

Organization ID

2009-0872

Secondary IDs

NCI-2011-01699

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 Wyeth is now a wholly owned subsidiary of Pfizer

Study Sponsor

Hagop Kantarjian, MD, Study Chair, M.D. Anderson Cancer Center


Verification Date

May 2019