Safety and Efficacy Evaluation of Decitabine With R-GDP

Phase 1

• Conditions: NHL
• Interventions: Drug: Decitabine and R-GDP

• Registration Number: NCT03535753
• Lead Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.

Brief Summary

Assessment of the Safety and efficacy of Administering decitabin plus R-GDP to NHL patients

Detailed Description

RR NHL patients will be treated with decitabin plus R-GDP , safety and efficacy will be assessed.

Study Timeline

• Status Verified: 2017-09
• Study Start: 2017-09-01
• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-05-14
• Last Update Submitted: 2018-05-14
• Study First Posted: 2018-05-24
• Last Update Posted: 2018-05-24
• Primary Completion: 2020-09-01
• Study Completion: 2020-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Relapsed or refractory Non-Hodgkin's lymphoma(NHL) patiens.
2. Eastern Cooperative Oncology Group(ECOG) score 0-2
3. Expected survival >3 months
4. Measurable disease.

Exclusion Criteria

1. Patients who needs treatment with immunosuppressive agents
2. Hematosepsis or Uncontrolled active infection
3. History of epilepsy or other CNS disease.
4. Active hepatitis B , hepatitis C or HIV infection or any other uncontrolled active infection.
5. Pregnancy or breast-feeding women.
6. Any uncontrolled medical disorders that the researchers considered are not suitable to participate the clinical trial.
7. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluatio

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Decitabine and R-GDP	Decitabine and R-GDP	ALL patients will be treated with Decitabine and R-GDP

Primary Outcome Measures

Name	Time	Method
OS	2 years	Overall survival

Trial Locations

Locations (1)

Peking university third hospital; 🇨🇳 Peking, Beijing, China