HLA-mismatched Microtransplantation for High Risk Acute M... | NCT01484171

Studies
HLA-mismatched Microtransplantation for High Risk Acute Myeloid Leukemia

NCT01484171

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Status

Unknown status

Last Update Posted

Jul 13, 2016Estimated

Enrollment

50Estimated

Phase

Phase 3

Conditions

Acute Myeloid Leukemia

Interventions

idarubicin
microtransplantation

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

Jul 2016

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

Aug 2011

Primary Completion Date

Aug 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Dec 1, 2011

First Submission Date that Met QC Criteria

Dec 1, 2011

First Posted Date

Dec 2, 2011Estimated

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

Jul 12, 2016

Last Update Posted Date

Jul 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 compare the antitumor efficacy and toxicity of Idarubicin and cytarabine in combination with or not with infusions of granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells in patients with newly diagnosed high-risk acute myeloid leukemia (AML).

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 3

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
idarubicin	Active Comparator	The patients will receive induction chemotherapy containing standard dose of idarubicin in combination with cytarabine.	Drug: idarubicin
microtransplantation	Experimental	The patients will receive induction chemotherapy containing high dose of idarubicin in combination with cytarabine and follow by infusioning granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells	Biological: microtransplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
idarubicin	Drug	idarubicin 10-12 mg/m2 for three days	idarubicin
microtransplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complete remission		one year

Secondary Outcomes

Measure	Description	Time Frame
disease-free survival		three years
overall survival		three years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Having signed informed consent
Diagnosis was based on the French-American-British (FAB) and WHO criteria.
Age ≥ 7 years old
Age < 60 years old

Exclusion Criteria:

1.Patients with a blast crisis of chronic myeloid leukemia or acute promyelocytic leukemia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
huisheng ai, Doctor of Medicine	Contact	86-01-66947126		huishengai@163.com

Overall Officials

Name	Affiliation	Role
huisheng ai, M.D.	The Affiliated Hospital of the Chinese Academy of Military Medical Science	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Affiliated Hospital of the Chinese Academy of Military Medical Science	Recruiting	Beijing	Beijing Municipality	100071	China

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015255	Idarubicin

Ancestor Terms

ID	Term
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided