NCT03535753

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

May 24, 2018

Status Verified

September 1, 2017

Enrollment Period

3 years

First QC Date

May 14, 2018

Last Update Submit

May 14, 2018

Conditions

NHL

Outcome Measures

Primary Outcomes (1)

  • OS

    Overall survival

    2 years

Study Arms (1)

Decitabine and R-GDP

EXPERIMENTAL

ALL patients will be treated with Decitabine and R-GDP

Drug: Decitabine and R-GDP

Interventions

Decitabine and R-GDPDRUG

Decitabine and R-GDP

Also known as: DR
Decitabine and R-GDP

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking university third hospital

Beijing, Beijing Municipality, 010, China

RECRUITING

MeSH Terms

Interventions

Decitabine

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Hongmei Jing, MD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xian lu, Dr

CONTACT

86luxinan@immunochina.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2018

First Posted

May 24, 2018

Study Start

September 1, 2017

Primary Completion

September 1, 2020

Study Completion

November 1, 2020

Last Updated

May 24, 2018

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)