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AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy

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ClinicalTrials.gov Identifier: NCT02024308
Recruitment Status : Unknown
Verified December 2013 by Xianmin Song, Changhai Hospital.
Recruitment status was:  Recruiting
First Posted : December 31, 2013
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):
Xianmin Song, Changhai Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia AML1-ETO Fusion Protein Expression Drug: Fludarabine Drug: Cytarabine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Fludarabine in Combination With Cytarabine Versus High -Dose Cytarabine in Post-remission Therapy for AML1-ETO Acute Myeloid Leukemia
Study Start Date : November 2010
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : December 2016


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.
Drug: Fludarabine
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 Name: Fludara

Drug: Cytarabine
2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4
Other Name: Cytosar

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.
Drug: Cytarabine
2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4
Other Name: Cytosar




Primary Outcome Measures :
  1. Percentage of participants with disease recurrence [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Percentage of Participants in survival [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024308


Contacts
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Contact: Xianmin Song, Doctor 83-21-31161285 shongxm@gmail.com

Locations
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China
Department of Hematology, Changhai Hospital Recruiting
Shanghai, China, 200433
Contact: Xianmin Song    86-21-31161285    shongxm@gmail.com   
Principal Investigator: Xianmin Song         
Sponsors and Collaborators
Changhai Hospital
Investigators
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Principal Investigator: Xianmin Song, Doctor Department of Hematology, Changhai Hospital

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Responsible Party: Xianmin Song, Associate Professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT02024308     History of Changes
Other Study ID Numbers: CHXY-AML01
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013
Keywords provided by Xianmin Song, Changhai Hospital:
acute myeloid leukemia,
AML1-ETO fusion protein,
Fludarabine,
recurrence
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Vidarabine
Cytarabine
Fludarabine
Fludarabine phosphate
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents