Safety and Efficacy Evaluation of Decitabine With R-GDP

Beijing Immunochina Medical Science & Technology

Status and phase: Unknown; Phase 1

Conditions: NHL

Treatments: Drug: Decitabine and R-GDP

Study type: Interventional

Funder types: Industry

Identifiers

NCT03535753

M201791

Details and patient eligibility

About

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

Full description

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Decitabine and R-GDP

Experimental group

Description:

ALL patients will be treated with Decitabine and R-GDP

Treatment:

Drug: Decitabine and R-GDP