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Azacitidine plus chidamide in patients with T/NK-cell lymphoma : a prospective, multicentre, phase 2 trial

Azacitidine plus chidamide in patients with T/NK-cell lymphoma : a prospective, multicentre, phase 2 trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037232
Enrollment
Unknown
Registered
2020-08-27
Start date
2020-08-26
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

T/NK-cell lymphoma

Interventions

experimental group:Azacitidine plus chidamide

Sponsors

Anhui Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1.Patients with T/NK cell non-Hodgkin lymphoma confirmed by pathology. 2.70 years old and older at the first diagnosis or more than 60 years old and ECOG 2-4 (man and woman). 3.Relapsed and refractory patients must have received at least one systemic chemotherapy regimen. 4.There is at least one imaging measurable lesion (defined by NHL Lugano staging). 5.Able to understand the purpose and risks of the research, and provide signed and dated informed consent and authorization to use protected health information.

Exclusion criteria

Exclusion criteria: 1. Any other histological type of lymphoma. a. Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. b. Any history of treated or non-treated indolent lymphoma. 2. Central nervous system or meningeal involvement by lymphoma. 3. Major surgical procedures were performed within 14 days of treatment of DLBCL. 4. Severe and uncontrolled cardiovascular disease. 5. Poor bone marrow reserve as defined by neutrophils 2 fold ULN). 7. Poor hepatic function (total bilirubin level> 2 fold ULN, transaminases> 3 fold ULN) unless these abnormalities are related to the lymphoma. 8. Uncontrolled and active systemic fungi, bacteria, viruses or other infections. 9. HIV infection. 10. Uncontrolled and active HBV and HCV infection. 11. Situations that investigator found it inappropriate to join this trial.

Design outcomes

Primary

MeasureTime frame
PFS;best ORR;

Secondary

MeasureTime frame
ORR;PFS;OS;security;

Countries

China

Contacts

Public ContactDing Kai-Yang

JiangSu Province Hospital

dingkaiy@126.com+86 13966672170

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026