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A single arm exploring study on the efficacy and safety of Chidamide Tablets maintenance for prevention of T/NK cell tumor recurrence after allogeneic hematopoietic stem cell transplantation

A single arm exploring study on the efficacy and safety of Chidamide Tablets maintenance for prevention of T/NK cell tumor recurrence after allogeneic hematopoietic stem cell transplantation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053797
Enrollment
Unknown
Registered
2021-11-29
Start date
2022-01-01
Completion date
Unknown
Last updated
2023-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T/NK cell tumor

Interventions

Experimental group:Chidamide Tablets

Sponsors

Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Definite diagnosis of T/NK cell tumors: mainly including PTCL, T-ALL, ENKTL, ATLL, T-LGLL, CTCL, ANKL, T-LBL, and other types that the investigator considers appropriate for the study; 2. Receiving allo-HSCT; 3. Tumor assessment of PR and above within 2 months after transplantation; 4. Hematopoietic recovery within 60 days of transplantation; 5. Patient aged 18 to 65 years; 6. ECOG score 60; 7. estimated survival time >=3 months; 8. Agree to participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled active infection or persistent fever within 14 days before enrollment; 2. Significant history of cardiovascular and cerebrovascular diseases or events; history of mental illness; incapacity or limited ability; 3. Uncontrolled concomitant diseases, including but not limited to symptomatic heart failure, uncontrolled hypertension, unstable angina pectoris, active peptic ulcer or bleeding disorders; 4. Patients with long-term drug abuse, alcoholism so as to affect the evaluation of the test results; 5. Pregnant or lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 6. Patients less than 6 weeks after major organ surgery; 7. Abnormal liver function (total bilirubin > 1.5 times the normal value, ALT/AST > 3 times the normal value), abnormal renal function (serum creatinine > 3 times the normal value); 8. Patients are participating in other clinical trials, or plan to start the study treatment less than 1 month from the end of the previous clinical study treatment; 9. The researchers determine that they are not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Two-year Cumulative Relapse Rate in Patients Receiving Maintenance Cedaramide Following Allo-HSCT for T/NK-Cell Tumors;

Countries

China

Contacts

Public ContactXiao Yi

Tongji Hospital affiliated to Tongji Medical College, Huazhong University of Science and Technology

yixiao@tjh.tjmu.edu.cn+86 13036120269

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026