NCT03579082

A Clinical Trial of Decitabine in Relapse and Refractory Diffuse Large B Cell Lymphoma

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Mingzhi Zhang · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To explore the safety, tolerability and clinical effects of decitabine combined with R±DHAP for patients with replase and refractory Diffuse Large B cell lymphoma.

Detailed description

This is a randomized,controlled,prospective,open,multi-center clinical trial,amied to evaluate the safety, tolerability,and efficacy of decitabine combined with R±DHAP in replase and refractory Diffuse Large B cell lymphoma.A total of 60 patients are planned to be enrolled into the study.Patients with diagnosis of replase and refractory Diffuse Large B cell lymphoma will be into two groups,and be treated with decitabine pluse R±DHAP or only R±DHAP,respectively.The primary end points are objective responder rate(ORR) and time to progression(TTP) and the secondary end points include overall survival(OS) and progression free survival(PFS).

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Decitabine	Given ivgtt

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-06-01
• Completion: 2019-12-01
• First posted: 2018-07-06
• Last updated: 2018-09-14

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study