Safety and Efficacy Evaluation of Decitabine With R-GDP

NHL Clinical Trial

Official title:

Safety and Efficacy Evaluation of Decitabine With R-GDP on Refractory or Relapsed NHL Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03535753
• Other study ID #: M201791
• Status: Recruiting
• Phase: Phase 1
• Start date: September 1, 2017
• Est. completion date: November 1, 2020

Study information

• Verified date: September 2017
• Source: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Contact: xian lu, Dr
• Phone: 86
• Email: luxinan[@]immunochina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• NHL

Intervention

Drug:
• Decitabine and R-GDP
Decitabine and R-GDP

Locations

Country	Name	City	State
China	Peking university third hospital	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Immunochina Medical Science & Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS	Overall survival	2 years