- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04024241
Medium Dose of Cytarabine and Mitoxantrone (HAM)
July 16, 2019 updated by: Shenzhen People's Hospital
The Clinical Observationg on HAM for Acute Myeloid Leukemia
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yixuan Cao, master
- Phone Number: 15813880801
- Email: 358521758@qq.com
Study Locations
-
-
Guangdong
-
Shenzhen, Guangdong, China, 518000
- Recruiting
- Shenzhen
-
Contact:
- Yixuan Cao, master
- Phone Number: 15813880801
- Email: 358521758@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
people diagnosed as AML expect acute promyeloytic leukemia
Description
Inclusion Criteria:
people diagnosed as AML
Exclusion Criteria:
- acute promyeloytic leukemia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
high dose of cytarabine
|
high dose
high dose
high dose
|
HAM
medium dose of cytarabine and mitoxantrone
|
high dose
high dose
high dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
bone marrow suppression time
Time Frame: one month
|
time of agranulocytosis
|
one month
|
patient survival time
Time Frame: three years
|
disease free survival
|
three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Anticipated)
August 31, 2019
Study Completion (Anticipated)
August 31, 2019
Study Registration Dates
First Submitted
July 16, 2019
First Submitted That Met QC Criteria
July 16, 2019
First Posted (Actual)
July 18, 2019
Study Record Updates
Last Update Posted (Actual)
July 18, 2019
Last Update Submitted That Met QC Criteria
July 16, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Cytarabine
- Mitoxantrone
Other Study ID Numbers
- YLi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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