Fludarabine and Cytarabine Versus High-dose Cytarabine for CBF-AML

NCT02926586 | Completed Phase 4

• 1 other identifier: CBF-AML-2016
• Study Type: interventional
• Target: 68
• 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 core-binding factor acute myeloid leukemia

Conditions

Acute Myeloid Leukemia; Core-Binding Factor

Keywords

RUNX1-RUNX1T1; CBFβ-MYH11; fludarabine; cytarabine

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with disease recurrence

  Comparing the percentage of participants with disease recurrence with two therapeutic regimen

  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 1500mg/m2/d for 5 days intravenously.

Drug: Fludarabine

high-dose cytarabine

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

Fludarabine 50 mg/m2, IV (in the vein) in combination with cytarabine 1500mg/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

high-dose cytarabine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical and laboratory diagnosis of CBF-AML,including RUNX1-RUNX1T1 and CBF-MYH11 fusion gene rearrangement by PCR/FISH
• In status of complete remission after one to two courses of induction therapy
• Total bilirubinic acid ≤ 35μmol/L, AST/ALT\<2 times abnormal level, serum creatinine \< 1.5mg/ml
• Cardiac function: EF ≥ 50%
• Hydroxyurea can be used for patient with white blood cell count ≥ 50\*109/L
• ECOG (Eastern Cooperative Oncology Group) score: ≤ 2

You may not qualify if:

• Relapsed/refractory AML
• Serious liver/ kidney dysfunction
• Cardiac function level: 2 above
• Female in pregnancy or lactation
• With serious infection diseases or other diseases
• Not obey the principle of clinical study

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xianmin Song

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

fludarabine; fludarabine phosphate; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

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, Shanghai General Hospital, No. 100 Haining Road, Shang

  PRINCIPAL INVESTIGATOR

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: professor

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 6, 2016
• Study Start: January 1, 2017
• Primary Completion: August 16, 2020
• Study Completion: July 1, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

CN (1)