NCT03952572

Efficacy and Safety of CDOP vs CHOP for Newly Diagnosed Peripheral T-cell Lymphoma

Open-label Multi-center Randomized Non-inferiority Study to Compare Efficacy and Safety of Pegylated Liposomal Doxorubicin Versus Doxorubicin for Newly Diagnosed Peripheral T-cell Lymphoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 244 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Primary objective of the study is to compare the efficacy and safety of CDOP versus CHOP for newly diagnosed peripheral T-cell lymphoma (PTCL).

Detailed description

This is a open-label, multi-center, randomized, non-inferiority study to compare efficacy and safety of CDOP with standard CHOP regimen in patients with previously untreated PTCL. Study subjects are patients with histologically proven newly diagnosed PTCL. Patients are randomized 1:1 to receive either cyclophosphamide, pegylated liposomal doxorubicin, vincristine and prednisone (CDOP) administered in 3 week cycles for 6 cycles or cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered in 3 week cycles for 6 cycles.This study is divided into three phases: screening phase, treatment phase and follow-up phase. Patients will receive study drug(s) for up to 6 cycles, or until unacceptable toxicity will develop or progression or voluntary withdrawal.Adverse event of every treatment cycle will be recorded.Therapy efficacy will be evaluated after finishing 2 cycles, 4cycles and finishing 6 cycles therapy. Patients will be followed until disease progression, died or 2 years from the last patient randomized.

Conditions

• Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	750mg/m² ivgtt on day 1
DRUG	pegylated liposomal doxorubicin	40mg/m² ivgtt on day 1
DRUG	Vincristine	1.4mg/m²(Maximum 2 mg) ivgtt on day 1
DRUG	Prednisone	Prednisone100mg/m² po on day1-5
DRUG	Doxorubicin	50mg/m² ivgtt on day 1

Timeline

• Start date: 2019-05-10
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2019-05-16
• Last updated: 2019-05-16

Locations

1 site across 1 country: China