Medium Dose of Cytarabine and Mitoxantrone | NCT04024241

Studies
Medium Dose of Cytarabine and Mitoxantrone

NCT04024241

Sponsor

Shenzhen People's Hospital

Status

Unknown status

Last Update Posted

Jul 18, 2019Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Acute Myelogenous Leukemia
Chemotherapy

Interventions

Flow Cytometer
Mitoxantrone
Cytarabine

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 2019

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

Aug 31, 2019Estimated

Completion Date

Aug 31, 2019Estimated

First Submitted Date

Jul 16, 2019

First Submission Date that Met QC Criteria

Jul 16, 2019

First Posted Date

Jul 18, 2019Actual

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 16, 2019

Last Update Posted Date

Jul 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

By observation of the inpatients in shenzhen people's hospital,research the curative effect of the two chemotherapy schemes on AML-High dose of cytarabine and HAM.

Detailed Description

The patients of AML in shenzhen people's hospital were randomly divided into two therapy groups.One group was treated by High dose of cytarabine ,and the other was HAM.Evaluate the two chemotherapy schemes by bone marrow suppression time and patient survival time.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high dose of cytarabine		high dose of cytarabine	Device: Flow Cytometer Drug: Mitoxantrone Drug: Cytarabine
HAM		medium dose of cytarabine and mitoxantrone	Device: Flow Cytometer Drug: Mitoxantrone Drug: Cytarabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flow Cytometer	Device	high dose	HAM high dose of cytarabine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
bone marrow suppression time	time of agranulocytosis	one month
patient survival time	disease free survival	three years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

people diagnosed as AML

Exclusion Criteria:

acute promyeloytic leukemia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

people diagnosed as AML expect acute promyeloytic leukemia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yixuan Cao, master	Contact	15813880801		358521758@qq.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shenzhen	Recruiting	Shenzhen	Guangdong	518000	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
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
D008942	Mitoxantrone
D003561	Cytarabine

Ancestor Terms

ID	Term
D000880	Anthraquinones
D000095322	Anthrones
D000873	Anthracenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided