A pill after transplant: new hope to stop t-cell cancer relapse
NCT ID NCT07774377
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This trial tests whether taking chidamide, an oral drug, after a stem cell transplant can lower the chance of the cancer coming back in people with high-risk T-cell acute lymphoblastic leukemia or lymphoma. Participants are randomly assigned to receive chidamide for up to 24 months or standard follow-up. The study tracks relapse-free survival and overall survival to see if the maintenance therapy helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chidamide
- What this could lead to
- If effective, chidamide maintenance could become a standard post-transplant therapy to reduce relapse risk and improve survival in high-risk T-ALL/LBL patients.
- What could go wrong
- This is a phase 3 trial, but results are not yet known. Chidamide may cause side effects like blood count changes or infections, and the benefit may not be confirmed.
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 132 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 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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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.
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 14-70 years (inclusive). 2. Confirmed diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) according to the 2016 WHO classification, with an early T-cell precursor (ETP) phenotype defined by immunophenotypic criteria: CD1a-, CD8-, CD5 weak, with expression of one or more myeloid/stem cell markers (e.g., CD34, CD117, HLA-DR, CD13, CD33, CD11b, or CD65). 3. Have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT) and achieved complete remission (CR/CRh/CRi) with full donor chimerism (≥95% by STR or equivalent method). 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 5. Adequate organ function: * Creatinine clearance ≥60 mL/min (Cockcroft-Gault). * AST and ALT ≤3×ULN; total bilirubin ≤2×ULN (≤3×ULN for Gilbert's syndrome). * Left ventricular ejection fraction (LVEF) ≥50% by echocardiography. 6. Life expectancy \>8 weeks. 7. Willing and able to provide written informed consent and comply with study procedures. 8. For women of childbearing potential: negative serum/urine pregnancy test at baseline; and agreement to use highly effective contraception during treatment and for at least 6 months after the last dose. Exclusion Criteria: 1. Evidence of relapse or disease progression at screening or baseline. 2. Persistent significant myelosuppression (ANC \<1.0×10⁹/L or platelets \<25×10⁹/L within 7 days without transfusion support) unrelated to reversible causes. 3. Active grade 3-4 acute GVHD, or acute GVHD requiring systemic corticosteroids ≥0.5 mg/kg/day prednisone equivalent to control; or active moderate-severe chronic GVHD not well controlled by standard therapy. 4. Active autoimmune disease requiring systemic immunosuppression. 5. Clinically significant cardiovascular disease: uncontrolled arrhythmia, QTc prolongation \>470 ms (males) or \>480 ms (females), uncontrolled hypertension ≥160/100 mmHg, NYHA class III-IV heart failure, or acute myocardial infarction/unstable angina within 6 months. 6. Uncontrolled infections or other severe medical conditions that would increase study risk. 7. Uncontrolled chronic viral infections: HIV positive; HBV (HBsAg positive with HBV-DNA \>ULN or not on antiviral therapy); HCV (anti-HCV positive with HCV RNA \>ULN or not on antiviral therapy). 8. Pregnancy or breastfeeding, or unwillingness to use effective contraception. 9. Gastrointestinal disorders affecting oral drug absorption. 10. Inability to understand or comply with study requirements. 11. Use of other HDAC inhibitors or investigational anticancer agents within 14 days prior to randomization; use of strong CYP inducers/inhibitors that may significantly alter chidamide exposure; or live vaccination within 4 weeks before baseline.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Double-Barreled immune attack aims to wipe out T-ALL
- Chemotherapy showdown: which combo works best for T-Cell cancers in kids?
- Experimental CAR-T therapy targets tough childhood blood cancers