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出境医 / 临床实验 / Medium Dose of Cytarabine and Mitoxantrone (HAM)

Medium Dose of Cytarabine and Mitoxantrone (HAM)

Study Description
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.

Condition or disease Intervention/treatment
Acute Myelogenous Leukemia Chemotherapy Device: Flow Cytometer Drug: Mitoxantrone Drug: Cytarabine

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.
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Clinical Observationg on HAM for Acute Myeloid Leukemia
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019
Arms and Interventions
Group/Cohort Intervention/treatment
high dose of cytarabine
high dose of cytarabine
 Device: Flow Cytometer
high dose

Drug: Mitoxantrone
high dose

Drug: Cytarabine
high dose
HAM
medium dose of cytarabine and mitoxantrone
 Device: Flow Cytometer
high dose

Drug: Mitoxantrone
high dose

Drug: Cytarabine
high dose
Outcome Measures
Primary Outcome Measures :
  1. bone marrow suppression time [ Time Frame: one month ]
    time of agranulocytosis

  2. patient survival time [ Time Frame: three years ]
    disease free survival


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
people diagnosed as AML expect acute promyeloytic leukemia
Criteria

Inclusion Criteria:

people diagnosed as AML

Exclusion Criteria:

  • acute promyeloytic leukemia
Contacts and Locations

Contacts
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Contact: Yixuan Cao, master 15813880801 358521758@qq.com

Locations
Layout table for location information
China, Guangdong
Shenzhen Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Yixuan Cao, master    15813880801    358521758@qq.com   
Sponsors and Collaborators
Shenzhen People's Hospital
Tracking Information
First Submitted Date July 16, 2019
First Posted Date July 18, 2019
Last Update Posted Date July 18, 2019
Actual Study Start Date September 1, 2017
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2019)
  • bone marrow suppression time [ Time Frame: one month ]
    time of agranulocytosis
  • patient survival time [ Time Frame: three years ]
    disease free survival
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Medium Dose of Cytarabine and Mitoxantrone
Official Title The Clinical Observationg on HAM for Acute Myeloid Leukemia
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population people diagnosed as AML expect acute promyeloytic leukemia
Condition
  • Acute Myelogenous Leukemia
  • Chemotherapy
Intervention
  • Device: Flow Cytometer
    high dose
  • Drug: Mitoxantrone
    high dose
  • Drug: Cytarabine
    high dose
Study Groups/Cohorts
  • high dose of cytarabine
    high dose of cytarabine
    Interventions:
    • Device: Flow Cytometer
    • Drug: Mitoxantrone
    • Drug: Cytarabine
  • HAM
    medium dose of cytarabine and mitoxantrone
    Interventions:
    • Device: Flow Cytometer
    • Drug: Mitoxantrone
    • Drug: Cytarabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 16, 2019) 		250
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 31, 2019
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

people diagnosed as AML

Exclusion Criteria:

  • acute promyeloytic leukemia
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Yixuan Cao, master 15813880801 358521758@qq.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04024241
Other Study ID Numbers YLi
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Shenzhen People's Hospital
Study Sponsor Shenzhen People's Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Shenzhen People's Hospital
Verification Date July 2019

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