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Can a Chemo-Antibody combo beat a tough leukemia?
NCT ID NCT03488225
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This phase II trial is testing whether adding the targeted antibody-drug inotuzumab ozogamicin to a standard chemotherapy regimen (Hyper-CVAD) improves outcomes for adults with B-cell acute lymphoblastic leukemia. The study enrolls people with newly diagnosed or recently remitted disease. Researchers are measuring how long participants remain free of cancer progression or death.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of chemotherapy drugs (cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine) plus the antibody-drug conjugate inotuzumab ozogamicin
- What this could lead to
- If successful, this approach could offer a more effective first-line treatment for B-cell acute lymphoblastic leukemia, potentially improving remission rates and long-term survival.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply broadly. The combination therapy carries risks of serious side effects, including infection and organ damage.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
4 people
The number who actually took part.
- Started
-
Mar 2018
- Finished
-
Apr 2020
- 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
-
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 newly diagnosed, previously untreated B-lineage ALL, or having achieved complete remission (CR) with one course of induction chemotherapy * Patients with extramedullary disease only are eligible * Failure to one induction course of chemotherapy (these patients will be analyzed separately) * Performance status of 0-3 * Creatinine less than or equal to 2.0 mg/dL (unless considered tumor related) * Bilirubin less than or equal to 2.0 mg/dL (unless considered tumor related) * Adequate cardiac function as assessed by history and physical examination * No active or co-existing malignancy with life expectancy less than 12 months * Women of childbearing potential (WOCBP) or male subjects with a partner who is WOCBP must agree to use contraception during the study, if sexually active Exclusion Criteria: * Pregnant or nursing women * Known to be human immunodeficiency virus (HIV)-positive * Philadelphia chromosome (Ph)-positive ALL * Active and uncontrolled disease/infection as judged by the treating physician * Unable or unwilling to sign the consent form * Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement or stable chronic liver disease per investigator assessment) * Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C
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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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