High Dose Donor Hematopoietic Stem Cell Infusion for Rela... | NCT03080922

Studies
High Dose Donor Hematopoietic Stem Cell Infusion for Relapsed/Refractory AML

NCT03080922

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Status

Unknown status

Last Update Posted

Apr 4, 2017Actual

Enrollment

10Estimated

Phase

Phase 1Phase 2

Conditions

Leukemia, Myeloid

Interventions

hematopoietic stem cell

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

Mar 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

Mar 2016Actual

Primary Completion Date

Mar 2018Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

Mar 10, 2017

First Submission Date that Met QC Criteria

Mar 10, 2017

First Posted Date

Mar 15, 2017Actual

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

Mar 30, 2017

Last Update Posted Date

Apr 4, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to evaluate the safety and efficiency of high dose allogeneic mismatched hematopoietic stem cells infusions after normal chemotherapy in patients with relapsed/refractory acute myeloid leukemia（AML）.

Detailed Description

The relapsed/refractory AML patients will receive IA/DA/MA(I,Idamycin，D，Daunorubicin，M，Mitoxantrone，A，cytosine arabinoside) chemotherapy followed by infusion of high dose allogeneic mismatched hematopoietic stem cells.

no graft-versus-host disease (GVHD) prevention will be conducted before transplantation. Cytokine storm,GVHD snd donor graft will be detected post-transplantation.

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

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hematopoietic stem cell	Experimental	high dose of donor granulocyte colony-stimulating factor（G-CSF）mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy	Biological: hematopoietic stem cell

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hematopoietic stem cell	Biological	high dose of donor G-CSF mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy	hematopoietic stem cell

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complete remission rate		2 months

Secondary Outcomes

Measure	Description	Time Frame
Disease-free survival		2 years
Overall survival		2 years
donor graft rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with relapsed and/or refractory AML
Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

Previous treatment with investigational gene or cell therapy medicine products
Any uncontrolled active medical disorder that would preclude participation as outlined

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
HUISHENG AI	Contact			HUISHNGAI@163.COM

Overall Officials

Name	Affiliation	Role
HUISHENG AI	Affiliated Hospital of Academy of Military Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Affiliated Hospital of Academy of Military Medical Sciences ,	Recruiting	Beijing	Beijing Municipality	100071	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007951	Leukemia, Myeloid
D015470	Leukemia, Myeloid, Acute
D012008	Recurrence

Ancestor Terms

ID	Term
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided