Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) With CMC-544 (Inotuzumab Ozogamycin), With or Without Later Addition of Rituximab
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.
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Response
Primary endpoint for efficacy is response which is defined as: Complete Remission (CR), Complete Remission without platelet recovery (CRp) or Partial Remission (PR).
4 week cycle
Hagop Kantarjian, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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