HAM: Medium Dose of Cytarabine and Mitoxantrone

Sponsor
Shenzhen People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04024241
Collaborator
(none)
250
1
24
10.4

Study Details

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 Phase

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

Study Type:
Observational
Anticipated 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 :
Sep 1, 2017
Anticipated Primary Completion Date :
Aug 31, 2019
Anticipated Study Completion Date :
Aug 31, 2019

Arms and Interventions

Arm 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 [one month]

    time of agranulocytosis

  2. patient survival time [three years]

    disease free survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

people diagnosed as AML

Exclusion Criteria:
  • acute promyeloytic leukemia

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shenzhen Shenzhen Guangdong China 518000

Sponsors and Collaborators

  • Shenzhen People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shenzhen People's Hospital
ClinicalTrials.gov Identifier:
NCT04024241
Other Study ID Numbers:
  • YLi
First Posted:
Jul 18, 2019
Last Update Posted:
Jul 18, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Keywords provided by Shenzhen People's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2019