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A phase I clinical study of the safety, tolerability, pharmacokinetics and efficacy of Azacitidine for injection combined with Chidamide in patients with relapsed/refractory T-cell lymphoma

A phase I clinical study of the safety, tolerability, pharmacokinetics and efficacy of Azacitidine for injection combined with Chidamide in patients with relapsed/refractory T-cell lymphoma

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040043
Enrollment
Unknown
Registered
2020-11-19
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

T cell lymphoma

Interventions

1:Dose group 1: azacitidine 50mg/m2, iv, d1-7
Chidamide 20mg, po, biw, taking the medicine for 3 weeks
4 weeks as a cycle
2:Dose group 2: azacitidine 75mg/m2, iv, d1-7
3:Dose group 3: azacitidine 50mg/m2, iv, d1-7
Chidamide 30mg, po, biw, taking the medicine for 3 weeks
4:Dose group 4: Azacytidine 75mg/m2, iv, d1-7
5:RP2D

Sponsors

Tianjin Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; ECOG score =100g/L, absolute neutrophil count >=1.5x10^9/L, platelets >=80x10^9/L, ALT, AST=1.5 ULN, serum albumin >=30g/L; 6. With at least one measurable lesion; 7. Without other serious diseases that conflict with this plan, and the cardiopulmonary function is basically normal; 8. Women of childbearing age must have a negative urine or blood pregnancy test, and male patients must use contraception during medication; 9. Without other anti-tumor concomitant therapy, but bisphosphonate anti-bone metastasis therapy and other symptomatic treatments can be applied; 10. Those who can understand the situation of this research and voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to the drugs in this plan; 2. Those who refuse to take reliable contraceptive measures during pregnancy, lactation or age; 3. Those who have any uncontrollable medical diseases (including uncontrolled diabetes, severe heart, lung, liver, and kidney insufficiency); 4. Accompanied by severe infection; 5. People with primary or secondary central nervous system tumor invaders; 6. Those who have chemotherapy contraindications; 7. Known active period of HBV or HCV infection (HBV virus copy number >=2x103IU/mL; HCV virus copy number >=103IU/mL); 8. Known HIV positive or HIV-related malignant tumors; 9. Those who take drugs or long-term alcoholism that affect the evaluation of test results; 10. People with peripheral nervous system disorders or mental disorders; 11. Those who are incapable of legal conduct, and those whose medical or ethical reasons affect the continuation of research; 12. Participate in other clinical research at the same time; 13. Combine anti-tumor drugs outside the research protocol.

Design outcomes

Primary

MeasureTime frame
RP2D;MTD;

Countries

China

Contacts

Public ContactZhang Huilai

Tianjin Cancer Hospital

zhlwgq@126.com+86 18622221228

Outcome results

None listed

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