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Clinical study of DC-Gemox regimen in relapse or refractory AITL

Clinical study of DC-Gemox regimen in relapse or refractory AITL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075967
Enrollment
Unknown
Registered
2023-09-20
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

Angioimmunoblastic T cell lymphoma

Interventions

Therapy group:Duvelisib and Chidamide in combination with CHOP regimen

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. AITL patients were confirmed by pathology. 2. First-line treatment with Anthracycline does not result in complete remission or disease progression during any course of treatment or relapse at any time. 3. At least one measurable lesion was required for any lymph node lesion larger than 1.5 cm in length or extranodal lesion larger than 1 cm in length and PET lesion uptake (SUV greater than hepatic blood pool). 4. Age 18-70, male or female. 5. ECOG score is 0-2. 6. Obtain informed consent signed by the patient or family member.

Exclusion criteria

Exclusion criteria: 1. Received systemic or local treatment including chemotherapy in the first three weeks. 2. Liver and kidney function: blood bilirubin > 2 mg/dl (35 umol/L), AST/ALT was more than 2 times of the upper limit of normal, serum creatinine was more than 177 umol/L, the creatinine clearance rate was less than 60 ml/min. 3. Normal heart function: EF <= 50%. 4. The expected survival time was less than 3 months. 5. Chronic or current active infectious diseases requiring systemic antibiotics, antifungal agents or antiviral therapy. 6. Other concurrent and uncontrollable factors are considered by the researchers to affect the medical status of patients participating in the study. Psychiatric patients or other patients who are known or suspected to be unable to fully comply with the study protocol. 7. People living with HIV.

Design outcomes

Primary

MeasureTime frame
Complete response rate;Progression free survival;

Secondary

MeasureTime frame
Overall survival;Objective response rate;Safety;Safety;

Countries

China

Contacts

Public ContactHongyan Tong

The First Affiliated Hospital, College of Medicine, Zhejiang University

hongyantong@aliyun.com+86 571 8723 5589

Outcome results

None listed

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