New combo therapy offers hope for tough leukemia cases
NCT ID NCT07541755
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment for adults with a type of leukemia (T-ALL) that has come back or not responded to standard therapy. The treatment combines an immunotherapy drug (PD-1 inhibitor) with a targeted drug (venetoclax) and chemotherapy. The goal is to see if this combination can help more patients achieve remission and improve survival, with the possibility of a stem cell transplant afterward.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Jan 2029
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 to 70 years
- 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. Age \>=18 years old; 2. Met the T-ALL diagnosis before enrollment (for specific diagnostic criteria, see the attachment); 3. Refractory T-ALL (newly diagnosed T-ALL that fails to achieve remission after treatment with one standard regimen) or recurrent T-ALL (bone marrow blasts exceed 5% again after remission, and the morphology and immunophenotype of leukemia cells are consistent with T-ALL); 4. The performance status score of the Eastern Cooperative Oncology Group (ECOG) in the United States ranges from 0 to 2 points. 5. Expected survival period \>=3 months; 6. During the screening period, there were no organ function abnormalities that restricted the use of this scheme. 7. Understand this study and sign the informed consent form. Exclusion Criteria: 1. Patients with refractory/relapsed T-ALL who are not suitable for or whose economic conditions restrict the use of PD-1 and venetoclax for treatment; 2. Diseases that may limit patients' participation in this trial due to abnormal functions of organs such as the heart, lungs, liver, and kidneys (such as advanced infections, uncontrolled diabetes, severe heart failure or angina pectoris, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, severe renal insufficiency, etc.); 3. There has been a history of other malignant tumors within the past five years; 4. Known HIV infection, active hepatitis B virus (HbsAg positive and HBV-DNA higher than the upper limit of the detection value) or active hepatitis C virus (anti-HCV antibody positive or HCV RNA positive) infection; 5. Inability to understand or comply with the research protocol; 6. Patients under 18 years old.
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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
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Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China