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A prospective, single-center, single-arm clinical study evaluating the efficacy and safety of pralatrexate combined with chidamide and azacitidine in adult patients with newly diagnosed peripheral T-cell lymphoma

A prospective, single-center, single-arm clinical study evaluating the efficacy and safety of pralatrexate combined with chidamide and azacitidine in adult patients with newly diagnosed peripheral T-cell lymphoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109351
Enrollment
Unknown
Registered
2025-09-17
Start date
2025-09-17
Completion date
Unknown
Last updated
2025-09-22

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

study group:pralatrexate combined with chidamide and azacitidine

Sponsors

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.According to the WHO Fifth Edition Classification of Lymphoid and Haematopoietic Tumors, the patient's pathological diagnosis corresponds to the following subtypes of Peripheral T-cell Lymphoma (PTCL): Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) Anaplastic large cell lymphoma, ALK-negative (ALCL, ALK-) Nodal follicular helper T-cell lymphoma (including angioimmunoblastic, follicular, and not otherwise specified variants) Hepatosplenic T-cell lymphoma (HSTCL) Enteropathy-associated T-cell lymphoma (EATL) Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL) Intestinal T-cell lymphoma, not otherwise specified (ITCL-NOS); 2.Aged between 18 and 80 years old; 3.PTCL patients diagnosed for the first time, who have not received radiotherapy, chemotherapy or other treatments; 4.PET-CT or CT/MRI shows at least one measurable lesion in two dimensions (longest diameter > 1.5 cm); 5.Women of childbearing age must have a negative pregnancy test result and be willing to use effective contraception during the study period and for at least 12 months after the last dose of study medication; pregnant and breastfeeding women are excluded; all male participants must use contraception during the study period and for at least 3 months after the last dose of study medication; 6.Who can provide informed consent and understand and comply with all study requirements;

Exclusion criteria

Exclusion criteria: 1.Severe mental illness; 2.HIV infection; 3.Individuals with severe renal dysfunction (glomerular filtration rate 20); 5.History of other active malignancies; 6.Pregnant or lactating women; 7.Unable to understand or comply with the research protocol;

Design outcomes

Primary

MeasureTime frame
Progression-free survival;safety;

Secondary

MeasureTime frame
overall survival;partial remission rate;overall response rate;complete remission rate;

Countries

China

Contacts

Public ContactHongyan Tong

The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

hongyantong@aliyun.com+86 571 8723 6625

Outcome results

None listed

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