CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)
United States90 participantsStarted 2010-06-04
Plain-language 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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
. Zubrod performance status 0-3.
. 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.
. 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).
Exclusion criteria
. Patient with active heart disease (NYHA class \>/= 3 as assessed by history and physical examination).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a drug called CMC-544 specifically in relapsed or refractory ALL — since my leukemia has or hasn't come back or stopped responding to treatment, does my situation actually match what this trial was designed for, and would you consider me a candidate for a similar approach?
2Since this was a Phase 2 trial measuring how many patients responded to CMC-544, what did the results actually show about response rates, and how does that compare to other options available to me now that the trial is completed?
3CMC-544 is an antibody-drug conjugate that targets CD22 — do my leukemia cells express CD22, and does that affect whether this type of treatment would even be relevant for my case?
4Now that this trial is completed, is CMC-544 or a similar drug available outside of a clinical trial, or would I need to look for another active study to access this kind of treatment?
5Before considering a trial like this one for relapsed or refractory ALL, are there standard treatments or other clinical trials I should try first, and how would you weigh those options against what this completed study found?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients with a cardiac ejection fraction (as measured by either Radionuclide angiography (MUGA) or echocardiogram) \< 45% are excluded.
. 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.
. Prior allogeneic stem cell transplant in previous 4 months.
. Peripheral lymphoblasts \> 50 x 10\^9/L.
. Pregnant and breast-feeding patients are excluded.