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Prospective, single arm, single center study of Duvaliser combined with Cedarbamide in the treatment of newly treated peripheral T-cell lymphoma (PTCL)

Prospective, single arm, single center study of Duvaliser combined with Cedarbamide in the treatment of newly treated peripheral T-cell lymphoma (PTCL)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074093
Enrollment
Unknown
Registered
2023-07-30
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-07-30

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

Conditions

peripheral T-cell lymphoma (PTCL)

Interventions

Experimental group:duvelisib+Chidamide

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.70 years old = 18 years old; 2. The newly diagnosed PTCL confirmed by histopathology is one of the following subtypes; a) Angioimmunoblastic T-cell lymphoma (AITL); b) Follicular T helper cell lymphoma (T-FHCL); Including but not limited to the above two subtypes 3. ECOG = 3; According to the Lugano-2014 standard, there should be at least one measurable or evaluable tumor lesion; 5. The expected survival period from the date of signing the informed consent form is greater than 3 months; 6. The subject or guardian understands and signs the informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients who have previously received systemic treatment for lymphoma or are currently undergoing anticancer treatment; 2. Patients with known central nervous system (CNS) lymphoma or lymphoma involving CNS; 3. Significant active heart disease within the past 6 months, including: New York Heart Association (NYHA) Class III or IV congestive heart failure unstable angina pectoris or angina requiring surgical or medication intervention; And/or myocardial infarction; 4. Uncontrolled systemic fungal, bacterial, or viral infections (defined as persistent signs/symptoms related to infection that have not improved despite the use of appropriate antibiotics, antiviral therapy, and/or other treatments); 5. History of active virus infection and severe skin reaction of HIV (HIV), hepatitis B or hepatitis C; 6. Patients with any other active malignant tumor at the time of screening, except for adequately treated cervical Carcinoma in situ or breast cancer Carcinoma in situ, skin Basal-cell carcinoma or local skin squamous cell carcinoma; 7. Female subjects are in pregnancy and lactation; 8. Any serious uncontrolled systemic disease; 9. The researcher believes that it may increase the risk of the subject or interfere with the test results.

Design outcomes

Primary

MeasureTime frame
Safety;

Secondary

MeasureTime frame
objective response rate, ORR;Complete remission rate, CRR;duration of remission, DOR;progression free survival, PFS;

Countries

China

Contacts

Public ContactZhang Li Ling

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

lily1228@sina.com+86 158 7172 5926

Outcome results

None listed

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