AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy

NCT02024308 | Unknown Phase 4 DMC

• 1 other identifier: CHXY-AML01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; AML1-ETO Fusion Protein Expression

Keywords

acute myeloid leukemia,; AML1-ETO fusion protein,; Fludarabine,; recurrence

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with disease recurrence

  one year

Secondary Outcomes (1)

• Percentage of Participants in survival

  one year

Study Arms (2)

Fludarabine

EXPERIMENTAL

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; Drug: Cytarabine

HD-Arac

ACTIVE COMPARATOR

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

Interventions

Fludarabine DRUG

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

Also known as: Fludara

Fludarabine

Cytarabine DRUG

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

Also known as: Cytosar

Fludarabine; HD-Arac

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Serious liver/ kidney dysfunction
• Cardiac function level: 2 above
• Female in pregnancy or lactation
• With serious infection diseases or other diseases

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Department of Hematology, Changhai Hospital

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Interventions

fludarabine; fludarabine phosphate; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Xianmin Song, Doctor

  Department of Hematology, Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianmin Song, Doctor

CONTACT

83-21-31161285; shongxm@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 31, 2013
• Study Start: November 1, 2010
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 31, 2013

Record last verified: 2013-12

Locations

CN (1)