CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)
NCT01134575
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
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 = 1.5 mg/dL and Alanine transaminase (SGPT) or Aspartate transaminase (SGOT) = 3 x upper limit of normal [ULN], unless considered due to tumor), and renal function (creatinine = 2 mg/dL). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is = 2.0 mg/dL and creatinine = 3 mg/dL.
5. Male and female patients who are of childbearing potential agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 14 days of study start (applies only if patient is of childbearing potential. Non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized).
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.
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Descriptive Information | |||||
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Brief Title ICMJE | CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL) | ||||
Official Title ICMJE | 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:
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 Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Intervention Model Description: The study started as a single arm study of Inotuzumab Ozogamicin administered at two different dose levels. The protocol was later amended to modify to weekly Inotuxumab Ozogamicin administration. Masking: None (Open Label)Primary Purpose: Treatment | ||||
Condition ICMJE | Acute Lymphoblastic Leukemia | ||||
Intervention ICMJE |
| ||||
Study Arms ICMJE |
| ||||
Publications * | Kantarjian H, Thomas D, Jorgensen J, Jabbour E, Kebriaei P, Rytting M, York S, Ravandi F, Kwari M, Faderl S, Rios MB, Cortes J, Fayad L, Tarnai R, Wang SA, Champlin R, Advani A, O'Brien S. Inotuzumab ozogamicin, an anti-CD22-calecheamicin conjugate, for refractory and relapsed acute lymphocytic leukaemia: a phase 2 study. Lancet Oncol. 2012 Apr;13(4):403-11. doi: 10.1016/S1470-2045(11)70386-2. Epub 2012 Feb 21. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE | 90 | ||||
Original Estimated Enrollment ICMJE | 40 | ||||
Actual Study Completion Date ICMJE | April 18, 2018 | ||||
Actual Primary Completion Date | April 18, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Sex/Gender ICMJE |
| ||||
Ages ICMJE | 16 Years and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT01134575 | ||||
Other Study ID Numbers ICMJE | 2009-0872 NCI-2011-01699 ( Registry Identifier: NCI CTRP ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
| ||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||
Investigators ICMJE |
| ||||
PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |