Smart drug hunts down hidden leukemia cells
NCT ID NCT03441061
First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 4 times
Summary
This phase II trial tests inotuzumab ozogamicin, a drug that targets and kills leukemia cells carrying a specific marker (CD22). It enrolls 40 adults with B-cell acute lymphoblastic leukemia who are in remission but still have minimal residual disease (MRD) — tiny amounts of cancer that standard tests miss. The goal is to see if the drug can improve relapse-free survival and clear these hidden cells.
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 (Besponsa)
- What this could lead to
- If successful, this could offer a targeted treatment option for leukemia patients with lingering disease after standard therapy, potentially delaying or preventing relapse.
- What could go wrong
- This is a small, early-phase trial (40 participants) with no control group, so results may not be conclusive. The drug can cause serious side effects like liver toxicity and infections.
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
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2018
- Expected to finish
-
Feb 2027
An estimate. End dates often move.
- 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
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18 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: * Patients with B-lineage ALL in hematologic complete remission (CR) with molecular failure (ie, had never achieved an MRD-negativity status before inotuzumab ozogamicin) or had a molecular relapse (ie, became MRD positive after having been MRD negative) starting at any time point after 3 months of frontline therapy. Molecular disease or minimal residual disease is defined by any level of measurable residual disease identified by multicolor flow cytometry, PCR and/or next-generation sequencing (NGS). * Patients with B-lineage ALL in at least marrow CR in salvage 1 and beyond with MRD failure at any time point after 1 month of salvage therapy are allowed, including patients who received prior allogeneic stem cell transplantation. * Patients with Ph+ ALL can be enrolled in CR1 or CR2 and beyond. A TKI will be added at the discretion of the treating physician. MRD for these patients will be defined by either 1.) a ratio of BCR-ABL1 to ABL1 by PCR of ≥ 0.01% according to the International Scale for patients with p210 transcript or a ratio of BCR-ABL1 to ABL1 by PCR of ≥ 0.01% for patients with non-p210 transcripts, or 2.) detectable MRD at any level of measurable residual disease identified by multicolor flow cytometry and/or by NGS. * Performance status of 0, 1, or 2 * Creatinine clearance \>= 15 ml/min * Bilirubin \< 1.5 X upper limit of normal (ULN) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 3 X ULN * No active or co-existing malignancy with life expectancy less than 12 months Exclusion Criteria: * Pregnant or nursing women * Known to be human immunodeficiency virus positive (HIV+) * Active and uncontrolled disease/infection as judged by the treating physician * Unable or unwilling to sign the consent form * Active central nervous system (CNS) or extramedullary disease * Monoclonal antibodies therapy within 2 weeks before study entry * Radiotherapy or cancer chemotherapy (except for intrathecal prophylaxis and/or low-dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, steroids) or any investigational drug within 2 weeks before study entry
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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
-
M D Anderson Cancer Center
Houston, Texas, 77030, United States
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