New hope for T-ALL: drug clears hidden cancer cells after chemo
NCT ID NCT06570915
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests the drug daratumumab in adults with T-cell acute lymphoblastic leukemia (T-ALL) who still have tiny amounts of cancer cells (called minimal residual disease, or MRD) after standard chemotherapy. The goal is to see if daratumumab can clear these leftover cells and help prevent the cancer from coming back. The study was planned for multiple hospitals in China but was withdrawn before enrolling any participants.
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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.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
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.
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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 with newly diagnosed T-cell acute lymphoblastic leukemia confirmed by cell morphology and immunophenotype had flow MRD≥0.01% 3 months after chemotherapy; or patients with T-cell acute lymphoblastic leukemia relapsed achieved CR again after salvage chemotherapy, but the flow MRD was ≥0.01% 2. Age ≥18 years old, male or female 3. The expression of CD38 in tumor cells was positive 4. Men and women who may give birth agree to and use effective contraceptive methods 5. Main organ function assessment criteria: total bilirubin \< 1.5× upper normal limit (ULN), glutamic oxalic aminotransferase (AST) and glutamic alanine aminotransferase (ALT) ≤2.5×ULN; Serum creatinine \< 2×ULN; Myocardial enzyme \< 2×ULN; Serum amylase ≤1.5×ULN; Left ventricular ejection fraction (LEF) was \> 45% 6. Understand and sign the informed consent and agree to comply with the study requirements Exclusion Criteria: 1. SAEs related to the study emerged during the study, and the investigator judged that the necessity of quitting the project was greater than the benefit 2. In case of any situation in which the subjects could not tolerate the study regimen, the investigator assessed that the necessity of withdrawal from the regimen outweighed the benefit 3. The subject had an allergic reaction to any drug of the study regimen or other conditions that prevented the regimen from continuing 4. Subjects voluntarily asked to withdraw from the study at any time 5. Any situation in which the investigator determines that the benefit of withdrawing from the study outweighs the benefit
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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