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Safety and Efficacy Evaluation of Decitabine With R-GDP

Sponsor
Beijing Immunochina Medical Science & Technology Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03535753
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
38
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Decitabine and R-GDP
 Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy Evaluation of Decitabine With R-GDP on Refractory or Relapsed NHL Patients
Actual Study Start Date :
Sep 1, 2017
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Decitabine and R-GDP

ALL patients will be treated with Decitabine and R-GDP

Drug: Decitabine and R-GDP
Decitabine and R-GDP
Other Names:
  • DR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. OS [2 years]

      Overall survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking university third hospital Peking Beijing China 010

    Sponsors and Collaborators

    • Beijing Immunochina Medical Science & Technology Co., Ltd.

    Investigators

    • Principal Investigator: Hongmei Jing, MD, Peking University Third Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beijing Immunochina Medical Science & Technology Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03535753
    Other Study ID Numbers:
    • M201791
    First Posted:
    May 24, 2018
    Last Update Posted:
    May 24, 2018
    Last Verified:
    Sep 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Decitabine

    Study Results

    No Results Posted as of May 24, 2018