Treatment of CD20 Antibody Plus CIK for Patients With Ref... | NCT01828008

Studies
Treatment of CD20 Antibody Plus CIK for Patients With Refractory Lymphomas

NCT01828008

Sponsor

Han weidong

Status

Unknown status

Last Update Posted

Apr 10, 2013Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Lymphomas

Interventions

Not provided

Countries

Not provided

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

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

May 2015Estimated

Completion Date

May 2015Estimated

First Submitted Date

Apr 6, 2013

First Submission Date that Met QC Criteria

Apr 9, 2013

First Posted Date

Apr 10, 2013Estimated

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

Apr 9, 2013

Last Update Posted Date

Apr 10, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Han weidong, combination of anti-CD20 with CIK for refractory lymphomas, Chinese PLA General HospitalSponsor-Investigator

Lead Sponsor

Han weidongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To study the safety and efficacy of CD20 antibody usage followed by CIK transfusion in refractory and/or chemoresistant lymphomas.

Detailed Description

Autologous CIK transfusion within 3 days post CD20 antibody treatment.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Measure	Description	Time Frame
disease free survival		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- diagnosed as B-cell lymphoma with CD20 positiveness, and need to therapy

Exclusion Criteria:

- to refuse the therapy and need not tolerate the therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

the patients with CD20-positive Lymphomas

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided