New Antibody-Drug combo aims to tackle tough leukemia
NCT ID NCT01371630
First seen Jun 25, 2026 · Last updated Jul 16, 2026 · Updated 3 times
Summary
This study is testing a drug called inotuzumab ozogamicin, which is like a smart bomb that targets and kills leukemia cells, combined with low-intensity chemotherapy. The goal is to find the best dose and see if this combo works better than standard treatments for patients with acute lymphoblastic leukemia, especially older adults or those whose cancer has returned. The trial involves about 276 participants and is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- inotuzumab ozogamicin (a targeted antibody-drug conjugate) combined with chemotherapy drugs
- What this could lead to
- If successful, this could offer a more effective and less toxic treatment option for older or relapsed patients with acute lymphoblastic leukemia.
- What could go wrong
- This is an early-phase trial (Phase I/II), so the benefits are not yet proven. Side effects from the drug combination could be serious, and results may not apply to all patients.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 276 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2011
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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. Patients age 60 years or older with previously untreated ALL pre-B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL Minimal prior therapy (less than 1 week of steroids, vincristine, and/or 1 dose of anthracycline or alkylating agents) are allowed. 2. Patients unfit ≥ 18 - \< 60 years of age with previously untreated ALL pre- B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL (includes patients initiated on first cycle of hyper-CVAD before cytogenetics known. These patients could have received one or two cycles of chemotherapy with or without other TKIs and still eligible. These patients are defined as having at least one of the below comorbidities: 1. ECOG performance status ≥ 2 2. Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina) 3. Severe pulmonary disorder (e.g., DLCO ≤ 65% or FEV1 ≤ 65%) 4. Creatinine clearance \< 45 mL/min, and 5. Hepatic disorder with total bilirubin \> 1.5 x upper limit of normal <!-- --> 1. If they achieved CR, they are assessable only for event-free and overall survival, or 2. If they failed to achieve CR, they are assessable for CR, event-free, and overall survival 3. Patients age 60 years and older unfit for intensive chemotherapy with one or more comorbidities (e.g., renal insufficiency, heart disease, cardio-vascular disease, uncontrolled hypertension, diabetes, respiratory problems, among others) and a PS of ≥ 1. All ages of Jehovah's witness are eligible. 4. Zubrod performance status 0-3. 5. Adequate liver function (bilirubin \< 1.95 mg/dL and SGPT or SGOT \< 3 x upper limit of normal \[ULN\], unless considered due to tumor), and renal function (estimated creatinine clearance ≥50 mL/min/1.73 m2). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is \< 2.6 mg/dL and creatinine \< 3 mg/dL. 6. Provision of written informed consent. 7. Patients in first remission are eligible. 8. Patients with refractory-relapsed ALL, Burkitt lymphoma, Burkitt-like lymphoma with 11q aberration, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma not otherwise specified with marrow involvementBof any age are eligible. Exclusion Criteria: 1. Newly diagnosed Burkitt's Leukemia or Lymphoma, T-cell ALL or lymphoblastic lymphoma. 2. Patient with active heart disease (NYHA class \> 3 as assessed by history and physical examination). 3. Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) \< 40% are excluded. 4. Patients with active hepatitis are excluded. 5. Pregnant or breast-feeding women 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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