T-Cell Acute Lymphoblastic LeukemiaPhase 3CHI-HSCTNCT07774377
Chidamide Maintenance to Prevent Relapse After Allogeneic Hematopoietic Stem Cell Transplantation in Acute T-Lymphoblastic Leukemia/Lymphoma
A Phase 3 study testing Chidamide in people with T-Cell Acute Lymphoblastic Leukemia and T-Cell Lymphoblastic Lymphoma, run by First Affiliated Hospital of Zhejiang University.
Trial summary
This study evaluates whether chidamide maintenance therapy can effectively reduce the risk of relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with high-risk T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma (T-ALL/LBL). Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- T-Cell Acute Lymphoblastic Leukemia, T-Cell Lymphoblastic Lymphoma
- What is being tested?
- Chidamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 15 Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 14-70 years (inclusive).
- 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).
- 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).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate organ function:
- Creatinine clearance ≥60 mL/min (Cockcroft-Gault).
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- AST and ALT ≤3×ULN; total bilirubin ≤2×ULN (≤3×ULN for Gilbert's syndrome).
- Left ventricular ejection fraction (LVEF) ≥50% by echocardiography.
- Life expectancy >8 weeks.
- Willing and able to provide written informed consent and comply with study procedures.
- 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.
Who cannot join
- Evidence of relapse or disease progression at screening or baseline.
- Persistent significant myelosuppression (ANC <1.0×10⁹/L or platelets <25×10⁹/L within 7 days without transfusion support) unrelated to reversible causes.
- 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.
- Active autoimmune disease requiring systemic immunosuppression.
- 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.
- Uncontrolled infections or other severe medical conditions that would increase study risk.
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- 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).
- Pregnancy or breastfeeding, or unwillingness to use effective contraception.
- Gastrointestinal disorders affecting oral drug absorption.
- Inability to understand or comply with study requirements.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Chidamide Maintenance to Prevent Relapse After Allogeneic HSCT in Acute T-Lymphoblastic Leukemia/Lymphoma: A Multicenter Randomized Controlled Trial
This study evaluates whether chidamide maintenance therapy can effectively reduce the risk of relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with high-risk T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma (T-ALL/LBL). Chidamide is an oral selective histone deacetylase inhibitor (HDACi) with dual anti-tumor and immunomodulatory effects.
Participants will be randomized in a 1:1 ratio to receive either chidamide maintenance for up to 24 months or standard follow-up without maintenance. The primary endpoint is relapse-free survival (RFS). Key secondary endpoints include cumulative incidence of relapse (CIR), overall survival (OS), non-relapse mortality (NRM), incidence and severity of graft-versus-host disease (GVHD), safety profile, and patient-reported outcomes (PROs).
This multicenter, open-label, randomized controlled trial aims to provide high-level evidence on the efficacy and safety of chidamide as a post-transplant maintenance strategy. Approximately 132 patients will be enrolled across 6 transplant centers in China.
Read the detailed description
Study Design:
This is a prospective, multicenter, open-label, randomized, parallel-group, superiority clinical trial. A total of 132 patients with ETP-phenotype T-ALL/LBL who have achieved complete remission after allo-HSCT will be enrolled.
Intervention:
Chidamide Group: Oral chidamide 10 mg twice weekly (BIW) starting at Day +30 to +100 post-transplant. Treatment cycles are 4 weeks each, for a total of 26 cycles (approximately 24 months). Dose may be escalated to 20 mg BIW in case of MRD positivity.
Control Group: Standard follow-up without maintenance therapy. Regular assessments are performed per the same schedule as the treatment group.
Study Assessments:
Efficacy: Relapse-free survival (RFS), cumulative incidence of relapse (CIR), overall survival (OS), non-relapse mortality (NRM).
Safety: Adverse events graded by NCI-CTCAE v6.0, including hematologic toxicity, infections, and transplant-related complications (TA-TMA, VOD/SOS, etc.).
GVHD: Acute GVHD graded per MAGIC criteria, chronic GVHD per NIH 2014/2020 criteria.
Exploratory: Minimal/measurable residual disease (MRD) dynamics by multi-parameter flow cytometry (MFC) or qPCR/NGS; immune reconstitution (T/B/NK/Treg subsets); cytokine/chemokine profiling; patient-reported outcomes (EQ-5D-5L, FACT-BMT); and health economic evaluation.
Follow-up:
Patients will be followed for at least 24 months after the last patient is enrolled. The total study duration is expected to be approximately 4 years.
Statistical Analysis:
The primary analysis will be performed on the modified intention-to-treat (mITT) population. RFS will be estimated using the Kaplan-Meier method and compared by log-rank test. A Cox proportional hazards model will be used to estimate hazard ratios (HR) with 95% confidence intervals (CI). For competing risk events (e.g., NRM for CIR), the Fine-Gray subdistribution hazard model will be applied. Sensitivity analyses will be conducted to assess robustness.
Sample Size:
Based on Schoenfeld's formula for log-rank test, assuming a 2-year RFS of 55% in the control group and 75% in the chidamide group (HR ≈ 0.48), with a two-sided alpha of 0.05, power of 80%, and 1:1 allocation, approximately 59 events are required. Accounting for a 5% dropout rate, the total sample size is 132 patients (66 per group).
- Being tested
- Chidamide, Control Group
- Keywords
- Chidamide, T-cell acute lymphoblastic leukemia, T-cell lymphoblastic lymphoma
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
Oral chidamide 10 mg twice weekly (BIW) starting at Day +30 to +100 post-transplant. Treatment cycles are 4 weeks each, for a total of 26 cycles (approximately 24 months). Dose may be escalated to 20 mg BIW in case of MRD positivity.
Control GroupOther
Standard follow-up without maintenance therapy. Regular assessments are performed per the same schedule as the treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide Group | Experimental | Oral chidamide 10 mg twice weekly (BIW) starting at Day +30 to +100 post-transplant. Treatment cycles are 4 weeks each, for a total of 26 cycles (approximately 24 months). Dose may be escalated to 20 mg BIW in case of MRD positivity. Receives: Drug: Chidamide |
| Control Group | Sham comparator | Standard follow-up without maintenance therapy. Regular assessments are performed per the same schedule as the treatment group. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-Free Survival (RFS)
Time from randomization to the first occurrence of either: (1) disease relapse/progression confirmed by morphology, imaging, or MRD criteria, or (2) death from any cause. Donor lymphocyte infusion (DLI) triggered by MRD elevation is counted as a relapse event. Assessed by Kaplan-Meier method.
Measured: From randomization to event, assessed up to 2 years
Secondary outcomes (5)
Cumulative Incidence of Relapse (CIR)
Time from randomization to first relapse/progression, treating non-relapse mortality (NRM) as a competing risk. Analyzed using the Fine-Gray subdistribution hazard model.
Measured: From randomization to event, assessed up to 2 years
Overall Survival (OS)
Time from randomization to death from any cause. Assessed by Kaplan-Meier method.
Measured: From randomization to event, assessed up to 2 years
Non-Relapse Mortality (NRM)
Time from randomization to death without prior relapse/progression, treating relapse as a competing risk. Analyzed using the Fine-Gray model.
Measured: From randomization to event, assessed up to 2 years
Cumulative Incidence of Graft-versus-Host Disease (GVHD)
Cumulative incidence of acute GVHD (graded per MAGIC criteria) and chronic GVHD (graded per NIH 2014/2020 criteria), with death as a competing risk.
Measured: From randomization to event, assessed up to 2 years
Incidence of Adverse Events (AEs)
Incidence of all adverse events, treatment-emergent AEs, serious AEs (SAEs), and adverse events of special interest (AESIs, including TA-TMA, VOD/SOS, and CMV/EBV reactivation), graded by NCI-CTCAE v6.0.
Measured: From randomization until 28 days after last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Aug 2028 (estimated)
- Study completion15 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-Cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanmin Zhao, First Affiliated Hospital of Zhejiang University
- Investigators
- Yanmin Zhao, MD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774377
- Sponsor's protocol ID
- CHI-TALL-HSCT-001
- Acronym
- CHI-HSCT
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) for the primary and key secondary outcomes, along with the data dictionary and statistical analysis scripts (R code), will be made available upon reasonable request. Data sharing will begin 6 to 12 months after publication of the primary results. Requests must include a scientifically valid research proposal and documented ethics approval. A data use agreement will be required. All shared data will be de-identified to protect participant privacy. Requests should be directed to the principal investigator at the Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chidamide Maintenance to Prevent Relapse After Allogeneic HSCT in Acute T-Lymphoblastic Leukemia/Lymphoma: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07774377
- Acronym / sponsor ID
- CHI-HSCT / CHI-TALL-HSCT-001
- Keywords
- Chidamide, T-cell acute lymphoblastic leukemia, T-cell lymphoblastic lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Aug 2029 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates whether chidamide maintenance therapy can effectively reduce the risk of relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with high-risk T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma (T-ALL/LBL). Chidamide is an oral selective histone deacetylase inhibitor (HDACi) with dual anti-tumor and immunomodulatory effects.
Participants will be randomized in a 1:1 ratio to receive either chidamide maintenance for up to 24 months or standard follow-up without maintenance. The primary endpoint is relapse-free survival (RFS). Key secondary endpoints include cumulative incidence of relapse (CIR), overall survival (OS), non-relapse mortality (NRM), incidence and severity of graft-versus-host disease (GVHD), safety profile, and patient-reported outcomes (PROs).
This multicenter, open-label, randomized controlled trial aims to provide high-level evidence on the efficacy and safety of chidamide as a post-transplant maintenance strategy. Approximately 132 patients will be enrolled across 6 transplant centers in China.
Detailed description
Study Design:
This is a prospective, multicenter, open-label, randomized, parallel-group, superiority clinical trial. A total of 132 patients with ETP-phenotype T-ALL/LBL who have achieved complete remission after allo-HSCT will be enrolled.
Intervention:
Chidamide Group: Oral chidamide 10 mg twice weekly (BIW) starting at Day +30 to +100 post-transplant. Treatment cycles are 4 weeks each, for a total of 26 cycles (approximately 24 months). Dose may be escalated to 20 mg BIW in case of MRD positivity.
Control Group: Standard follow-up without maintenance therapy. Regular assessments are performed per the same schedule as the treatment group.
Study Assessments:
Efficacy: Relapse-free survival (RFS), cumulative incidence of relapse (CIR), overall survival (OS), non-relapse mortality (NRM).
Safety: Adverse events graded by NCI-CTCAE v6.0, including hematologic toxicity, infections, and transplant-related complications (TA-TMA, VOD/SOS, etc.).
GVHD: Acute GVHD graded per MAGIC criteria, chronic GVHD per NIH 2014/2020 criteria.
Exploratory: Minimal/measurable residual disease (MRD) dynamics by multi-parameter flow cytometry (MFC) or qPCR/NGS; immune reconstitution (T/B/NK/Treg subsets); cytokine/chemokine profiling; patient-reported outcomes (EQ-5D-5L, FACT-BMT); and health economic evaluation.
Follow-up:
Patients will be followed for at least 24 months after the last patient is enrolled. The total study duration is expected to be approximately 4 years.
Statistical Analysis:
The primary analysis will be performed on the modified intention-to-treat (mITT) population. RFS will be estimated using the Kaplan-Meier method and compared by log-rank test. A Cox proportional hazards model will be used to estimate hazard ratios (HR) with 95% confidence intervals (CI). For competing risk events (e.g., NRM for CIR), the Fine-Gray subdistribution hazard model will be applied. Sensitivity analyses will be conducted to assess robustness.
Sample Size:
Based on Schoenfeld's formula for log-rank test, assuming a 2-year RFS of 55% in the control group and 75% in the chidamide group (HR ≈ 0.48), with a two-sided alpha of 0.05, power of 80%, and 1:1 allocation, approximately 59 events are required. Accounting for a 5% dropout rate, the total sample size is 132 patients (66 per group).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chidamide Group | Experimental | Drug: ChidamideOral chidamide 10 mg twice weekly (BIW) starting at Day +30 to +100 post-transplant. Treatment cycles are 4 weeks each, for a total of 26 cycles (approximately 24 months). Dose may be escalated to 20 mg BIW in case of MRD positivity. |
| Control Group | Sham comparator | Other: Control GroupStandard follow-up without maintenance therapy. Regular assessments are performed per the same schedule as the treatment group. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Age 14-70 years (inclusive).
- 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).
- 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).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Adequate organ function:
Key exclusion criteria (11 listed)
- Evidence of relapse or disease progression at screening or baseline.
- Persistent significant myelosuppression (ANC <1.0×10⁹/L or platelets <25×10⁹/L within 7 days without transfusion support) unrelated to reversible causes.
- 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.
- Active autoimmune disease requiring systemic immunosuppression.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChidamideOral chidamide 10 mg twice weekly (BIW) starting at Day +30 to +100 post-transplant. Treatment cycles are 4 weeks each, for a total of 26 cycles (approximately 24 months). Dose may be escalated to 20 mg BIW in case of MRD positivity. | Drug | Chidamide Group |
| Control GroupStandard follow-up without maintenance therapy. Regular assessments are performed per the same schedule as the treatment group. | Other | Control Group |
Primary outcome
Relapse-Free Survival (RFS)
Time frame: From randomization to event, assessed up to 2 years
Time from randomization to the first occurrence of either: (1) disease relapse/progression confirmed by morphology, imaging, or MRD criteria, or (2) death from any cause. Donor lymphocyte infusion (DLI) triggered by MRD elevation is counted as a relapse event. Assessed by Kaplan-Meier method.
5 secondary outcomes
Cumulative Incidence of Relapse (CIR)
Time frame: From randomization to event, assessed up to 2 years
Overall Survival (OS)
Time frame: From randomization to event, assessed up to 2 years
Non-Relapse Mortality (NRM)
Time frame: From randomization to event, assessed up to 2 years
Cumulative Incidence of Graft-versus-Host Disease (GVHD)
Time frame: From randomization to event, assessed up to 2 years
Incidence of Adverse Events (AEs)
Time frame: From randomization until 28 days after last dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) for the primary and key secondary outcomes, along with the data dictionary and statistical analysis scripts (R code), will be made available upon reasonable request. Data sharing will begin 6 to 12 months after publication of the primary results. Requests must include a scientifically valid research proposal and documented ethics approval. A data use agreement will be required. All shared data will be de-identified to protect participant privacy. Requests should be directed to the principal investigator at the Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yanmin Zhao, MD principal investigator
First Affiliated Hospital of Zhejiang University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chidamide in people with T-Cell Acute Lymphoblastic Leukemia and T-Cell Lymphoblastic Lymphoma, run by First Affiliated Hospital of Zhejiang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanmin Zhao, MD (057187236706, yanminzhao@zju.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-Free Survival (RFS) (time frame: From randomization to event, assessed up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.