Can a smart drug missile tame Hard-to-Treat leukemia?
NCT ID NCT01134575
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This trial is investigating whether a targeted drug called CMC-544 (inotuzumab ozogamicin), given alone or later combined with rituximab, can control acute lymphoblastic leukemia (ALL) that has returned or not responded to standard treatment. The study enrolls adults and older children with relapsed or refractory ALL. Researchers are measuring how many patients achieve complete or partial remission to see if this approach offers a meaningful benefit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a targeted antibody-drug conjugate called inotuzumab ozogamicin (CMC-544), given alone or later combined with rituximab
- What this could lead to
- If effective, this approach could offer a new treatment option for patients with hard-to-treat ALL that has returned or not responded to prior therapy.
- What could go wrong
- This is a mid-stage trial with a modest number of participants, so results may not confirm benefit. The drug can cause serious side effects, including liver toxicity and low blood counts.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
90 people
The number who actually took part.
- Started
-
Jun 2010
- Finished
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Apr 2018
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
16 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \</= 1.5 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). 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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