NCT03558412

A Clinical Trial of Decitabine in Relapsed or Refractory T-lymphoblastic Lymphoma

A Clinical Trial of Decitabine Combined With CODOX-M/IVAC in Relapsed or Refractory T-lymphoblastic Lymphoma

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Mingzhi Zhang · Academic / Other
• Sex: All
• Age: 14 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To explore the safety, tolerability, and clinical effects of decitabine combined with Second-line chemotherapy regimens for patients with relapsed or refractory T-lymphoblastic lymphoma.

Detailed description

This is a prospective, open，investigator initial clinical trial with a single arm, aimed to evaluate the safety, tolerability, and efficacy of decitabine combined with Second-line chemotherapy regimens (CODOX-M/IVAC) in relapsed or refractory T-lymphoblastic lymphoma. A total of 40 patients are planned to be enrolled into the study. Patients with diagnosis of relapsed or refractory T-lymphoblastic lymphoma will be treated with decitabine plus CODOX-M/IVAC. The primary end point is responder rate (RR) and time to progression (TTP), and the secondary end points include overall survival (OS) and the median survival time (MST).

Conditions

• T-lymphoblastic Lymphoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	CODOX-M/IVAC	Given ivgtt
DRUG	Decitabine	Given ivgtt

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-12-01
• Completion: 2020-06-01
• First posted: 2018-06-15
• Last updated: 2018-09-14

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study