- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02024308
AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy
December 27, 2013 updated by: Xianmin Song, Changhai Hospital
A Randomized Comparison of Fludarabine in Combination With Cytarabine Versus High -Dose Cytarabine in Post-remission Therapy for AML1-ETO Acute Myeloid Leukemia
The purpose of the study is to determine whether Fludarabine in combination with cytarabine is more effective than high-dose cytarabine in post-remission therapy for patients with AML1-ETO acute myeloid leukemia.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
62
Phase
- Phase 4
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: Xianmin Song, Doctor
- Phone Number: 83-21-31161285
- Email: shongxm@gmail.com
Study Locations
-
-
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Shanghai, China, 200433
- Recruiting
- Department of Hematology, Changhai Hospital
-
Contact:
- Xianmin Song
- Phone Number: 86-21-31161285
- Email: shongxm@gmail.com
-
Principal Investigator:
- Xianmin Song
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical and laboratory diagnosis of AML1-ETO positive acute myeloid leukemia
- In status of complete remission after one to two courses of induction therapy with DA(Daunorubicin 60mg/m2/d for 3 days, cytarabine 100mg/m2/d for 5-7days) regimen
- ECOG (Eastern Cooperative Oncology Group) score: <2
Exclusion Criteria:
- Serious liver/ kidney dysfunction
- Cardiac function level: 2 above
- Female in pregnancy or lactation
- With serious infection diseases or other diseases
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fludarabine
The patients in experimental arm should receive the consolidation chemotherapy regimen with fludarabine and cytarabine.
The dosage of fludarabine is 30mg/m2/d for 5 days intravenously and cytarabine is 1.4g/m2/d for 5 days intravenously.
|
50 mg/m2, IV (in the vein) in combination with cytarabine 1.4mg/m2/d for 5 days with each cycle of 28 days.
Number of cycles: 4
Other Names:
2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days.
Number of cycles: 4
Other Names:
|
Active Comparator: HD-Arac
The patients in control arm should receive the consolidation chemotherapy regimen with high-dose cytarabine.
The dosage of cytarabine is 2000mg/m2/12h for 3 days (1,3,5) intravenously.
|
2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days.
Number of cycles: 4
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of participants with disease recurrence
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants in survival
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xianmin Song, Doctor, Department of Hematology, Changhai Hospital
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
November 1, 2010
Primary Completion (Anticipated)
November 1, 2015
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
December 20, 2013
First Submitted That Met QC Criteria
December 27, 2013
First Posted (Estimate)
December 31, 2013
Study Record Updates
Last Update Posted (Estimate)
December 31, 2013
Last Update Submitted That Met QC Criteria
December 27, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
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
- Antiviral Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Fludarabine
- Cytarabine
Other Study ID Numbers
- CHXY-AML01
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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