Safety and Efficacy Evaluation of Decitabine With R-GDP | NCT03535753

Studies
Safety and Efficacy Evaluation of Decitabine With R-GDP

NCT03535753

Sponsor

Beijing Immunochina Medical Science & Technology Co., Ltd.

Status

Unknown status

Last Update Posted

May 24, 2018Actual

Enrollment

50Estimated

Phase

Phase 1

Conditions

Interventions

Decitabine and R-GDP

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Sep 1, 2020Estimated

Completion Date

Nov 1, 2020Estimated

First Submitted Date

May 14, 2018

First Submission Date that Met QC Criteria

May 14, 2018

First Posted Date

May 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2018

Last Update Posted Date

May 24, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Decitabine and R-GDP	Experimental	ALL patients will be treated with Decitabine and R-GDP	Drug: Decitabine and R-GDP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Decitabine and R-GDP	Drug	Decitabine and R-GDP	Decitabine and R-GDP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OS	Overall survival	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
xian lu, Dr	Contact	86	189-1157-6946	luxinan@immunochina.com

Overall Officials

Name	Affiliation	Role
Hongmei Jing, MD	Peking University Third Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking university third hospital	Recruiting	Beijing	Beijing Municipality	010	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077209	Decitabine

Ancestor Terms

ID	Term
D001374	Azacitidine
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine

Browse Leaves

Not provided

Browse Branches

Not provided