DCs Vaccine Combined With Cytokine-induced Killer Cells i... | NCT01898663

Studies
DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML

NCT01898663

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Status

Unknown status

Last Update Posted

Jul 1, 2024Actual

Enrollment

30Estimated

Phase

Phase 1Phase 2

Conditions

High-risk Soft Tissue Sarcoma

Interventions

Adenovirus-transfected DC + CIK

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

Jun 2024

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

Jun 2013

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Jul 9, 2013

First Submission Date that Met QC Criteria

Jul 9, 2013

First Posted Date

Jul 12, 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

Jun 28, 2024

Last Update Posted Date

Jul 1, 2024Actual

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

The aim of this Phase Ⅰ/Ⅱ study is to evaluate the safety and efficacy of dendritic cells (DCs) vaccine combined with cytokine-induced killer (CIK) cells in patients with AML. Experimental recombinant adenovirus-transfected DCs, which engineered to express MUC1 and Survivin are used for DCs-based immunotherapy. Based on the results of our previously performed preclinical study with DCs vaccine combined with CIK cells, the investigators plan to perform the clinical trial.

Detailed Description

Not provided

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adenovirus-transfected DC + CIK	Experimental	Adenovirus-transfected autologous DCs + CIK cells	Biological: Adenovirus-transfected DC + CIK

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adenovirus-transfected DC + CIK	Biological	Adenovirus-transfected autologous DC vaccine plus CIK cells	Adenovirus-transfected DC + CIK

Measure	Description	Time Frame
PFS/OS		1 years after DC/CIK treatment

Measure	Description	Time Frame
Number of participants with adverse events		3 days within DC/CIK treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consistent with the diagnosis of AML
Age≥18 years at time of consent
KPS(Karnofsky Performance Scale) ≥70
Patient's written informed consent
No steroid therapy within 4 weeks of first DC vaccination
Stable disease, complete response and partial response(WHO, RECIST)
Predicted survival≥3 months

Exclusion Criteria:

Serious dysfunction of vital organs(heart, liver or kidney)
Received organ transplantation
Patients with other malignancies or brain metastases
History of autoimmune diseases
Pregnant and breast-feeding patient
Active or chronic infectious diseases
History of allergy or hypersensitivity to study product excipients
Currently participating in another clinical trial
Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks
Unfit for participating in this clinical trial in investigators' opinions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bin Zhang, M.D., Ph.D.	Contact	+86-010-6694-7125		zb307ctc@163.com

Overall Officials

Name	Affiliation	Role
Chen Hu, M.D., Ph.D.	Affiliated Hospital to Academy of Military Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Hematopoietic Stem Cell Transplantation	Recruiting	Beijing		100071	China