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A prospective, open-lable, single-arm, muti-center study evaluating the efficacy and saftety of chidamide in combination with CHOP in patients with newly diagnosed peripheral T-cell lymphoma (PTCL)

A prospective, open-lable, single-arm, muti-center study evaluating the efficacy and saftety of chidamide in combination with CHOP in patients with newly diagnosed peripheral T-cell lymphoma (PTCL)

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17011303
Enrollment
Unknown
Registered
2017-05-04
Start date
2017-05-08
Completion date
Unknown
Last updated
2017-05-09

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

Conditions

Peripheral T-cell lymphoma

Interventions

Experimental group:Chidamide+CHOP

Sponsors

the First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed with peripheral T-cell lymphoma (PTCL) according to 2008 WHO disease classification; 2. Aged between 18 and 70 years old; 3. ECOG perfomance status =2; 4. Women of childbearing potential and men must agree to use effective contraception. This applies for the time period between signing of the informed consent form and 12 months after the last administration of the study treatment; 5. At least one measurable lesion defined as one lesion larger than 1.0cm or skin lesions measured by physical examination; 6. Willingness to sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. T lymphoblastic lymphoma; 2. Bone morrow was affected and the Lymphoma cell more than 25%; 3. ALK+ Anaplastic large T cell lymphoma; 4. NK/T cell lymphoma; 5. Granuloma fungoides; 6. Severe hepatic and renal dysfunction:alanine aminotransferase (ALT), total bilirubin or creatinine >3*ULN; 7. Uncontrolled active infection; 8. Organic cardiopathy accompanied by clinical symptoms or abnormal cardiac function (NYHA =2); 9. With other malignant tumors.

Design outcomes

Primary

MeasureTime frame
CR/PR;

Countries

China

Contacts

Public ContactZhengming Jin

the First Affiliated Hospital of Soochow University

jinzhengming@medmail.com.cn+86 13862553199

Outcome results

None listed

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