New maintenance therapy shows promise in preventing T-Cell cancer relapse after transplant
NCT ID NCT05991973
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a low dose of the drug chidamide, given after a donor stem cell transplant, can help prevent T-cell acute lymphoblastic leukemia or T-cell lymphoma from coming back. Forty-four patients aged 14 to 70 who were at high risk of relapse took part. The main goal was to see how long they stayed cancer-free without major side effects.
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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.
- Participants
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44 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Jul 2025
- 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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14 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.
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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. T-cell acute lymphoblastic leukemia or T-cell lymphomas (mainly including peripheral T-cell lymphoma, NK/T-cell lymphoma, T-lymphoblastic lymphoma, etc.) must be diagnosed before enrollment. The diagnostic criteria refer to the 2016 WHO classification. Patients is in high-risk group or standard-risk group with MRD-positive patients after transplantation. 2. Age 14-70; 3. Stable hematopoietic reconstitution after receiving allogeneic hematopoietic stem cell transplantation, no aGVHD or stable aGVHD control and stable primary disease; 4. Complete donor chimerism after transplantation; 5. During the screening period after transplantation (within 4 weeks before Chidanilide administration), the primary disease is remission and MRD is negative. 6. Eastern Cooperative Oncology Group (ECOG) physical condition score is 0-2 points; 7. Creatinine clearance ≥ 60 mL/min (according to the Cockcroft-Gault formula); 8. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal range (ULN), total bilirubin ≤ 2 × ULN; 9. Echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) ≥ 50% 10. Life expectancy \>8 weeks; 11. Voluntarily sign the informed consent form, understand and comply with the requirements of the research. Exclusion Criteria: 1. Bone marrow recurrence or extramedullary recurrence after transplantation; 2. Hemocytopenia after transplantation: white blood cells \<2000/ul, platelets \<25000/ul; 3. Active grade 3-4 acute GVHD, or active moderate-to-severe chronic GVHD that cannot be controlled by drugs; 4. Active autoimmune diseases, such as SLE, rheumatoid arthritis, etc.; 5. Currently suffering from clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, prolonged QTc interval of electrocardiogram, uncontrolled uncontrolled hypertension, congestive heart failure, any New York Heart Association (NYHA) functional class 3 or 4 cardiac disease, or a history of myocardial infarction within 6 months before screening; 6. Other serious diseases that may limit patients to participate in this trial (such as advanced infection, uncontrolled diabetes, renal failure); 7. Known human immunodeficiency virus (HIV) infection, or hepatitis B virus that cannot be controlled by drugs (HBV-DNA positive, and HBV DNA test value above the upper limit of normal value) or hepatitis C virus (anti-HCV positive, and HCV viral titer detection value above the upper limit of normal value) Chronic Infect; 8. Pregnant or lactating women; 9. Those who cannot understand and follow the research protocol or cannot sign the informed consent form;
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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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The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, 310006, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can engineered cells beat relapsed blood cancers?
- A pill after transplant: new hope to stop t-cell cancer relapse
- Can a simple blood test spot lymphoma earlier?
- Personalized chemo dosing may boost survival in kids with High-Risk leukemia
- Engineered immune cells take aim at Hard-to-Treat T-Cell cancers
- Engineered immune cells take aim at stubborn blood cancers