Safety and Efficacy Evaluation of Decitabine With R-GDP

NCT ID: NCT03535753

Last Updated: 2018-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-11-01

Brief Summary

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

Detailed Description

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

Conditions

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NHL

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Decitabine and R-GDP

ALL patients will be treated with Decitabine and R-GDP

Group Type EXPERIMENTAL

Decitabine and R-GDP

Intervention Type DRUG

Decitabine and R-GDP

Interventions

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Decitabine and R-GDP

Decitabine and R-GDP

Intervention Type DRUG

Other Intervention Names

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DR

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Immunochina Medical Science & Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hongmei Jing, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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Peking university third hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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xian lu, Dr

Role: CONTACT

86 ext. 189-1157-6946

Facility Contacts

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Xinan Lu, Dr

Role: primary

Other Identifiers

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M201791

Identifier Type: -

Identifier Source: org_study_id

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