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A Phase II Study of pegylated liposomal doxorubicin, cyclophosphamide, vincristine and prednisone in Patients With Peripheral T-Cell Lymphoma (PTCL)

A Phase II Study of pegylated liposomal doxorubicin, cyclophosphamide, vincristine and prednisone in Patients With Peripheral T-Cell Lymphoma (PTCL)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054588
Enrollment
Unknown
Registered
2021-12-20
Start date
2015-09-17
Completion date
Unknown
Last updated
2022-11-28

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:Combination chemotherapy with polyethylene glycol modified liposome doxorubicin (PLD), cyclophosphamide, vincristine and prednisone

Sponsors

Cancer Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. ECOG PS Score: 0-2; 3. Pathology: Histologically confirmed initial treatment of aggressive Non-Hodgkin's lymphoma with T cells; - Includes peripheral T cell lymphoma, non-specific (PTCL NOS), vascular immunoblastic T cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL), and other aggressive T cell types (except NK/T cell lymphoma) 4. Objective measurable lesions (according to WHO standards); 5. Signed informed consent; 6. Estimated survival time >= 6 months; 7. Cardiac function: LVEF >= 50% by RNA detection, no myocardial ischemia by EKG, and no history of arrhythmia requiring drug intervention before enrollment 8. Hematopoietic function: WBC >= 4.0x10^9/L, ANC >= 2.0x10^9/L, PLT >= 100x10^9/L, Hb >= 90 g/L; 9. Liver function: total bilirubin, ALT and AST all = 50 mL /min.

Exclusion criteria

Exclusion criteria: 1. With primary or secondary central nervous system involvement; 2. Previous or concurrent heart disease, including congenital heart disease or pericardial disease, history of heart failure, myocardial infarction, coronary heart disease, heart valvular disease, cardiomyopathy, arrhythmias (including persistent atrial fibrillation, complete left bundle branch block, frequent ventricular premature onset); 3. Previous severe chronic skin diseases; 4. Previous allergic asthma or severe allergic disease; 5. Poorly controlled hypertension and diabetes; 6. Have a history of other tumors, except cured cervical cancer or basal cell carcinoma of the skin; 7. Patients infected with HIV, HCV or syphilis; 8. Pregnant or lactating women; 9. Patients who have previously received organ transplants; 10. Severe active infection; 11. Contraindications to the use of large doses of hormones, such as uncontrolled hyperglycemia, gastric ulcers or mental diseases; 12. A history of severe neurological or psychiatric disorders, including dementia or epilepsy.

Design outcomes

Primary

MeasureTime frame
objective response rate;

Secondary

MeasureTime frame
2-year progression-free survival;

Countries

China

Contacts

Public ContactGuo Ye

Cancer Hospital affiliated to Fudan University

pattrickguo@gmail.com+86 13501678472

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026