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

• ClinicalTrials.gov Identifier: NCT02926586
• Recruitment Status: Unknown
• First Posted: October 6, 2016
• Last Update Posted: May 2, 2018
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Information provided by (Responsible Party): Xianmin Song, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Tracking Information

• First Submitted Date: October 5, 2016
• First Posted Date: October 6, 2016
• Last Update Posted Date: May 2, 2018
• Study Start Date: July 2016
• Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 5, 2016): Percentage of participants with disease recurrence [ Time Frame: one year ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 5, 2016): Percentage of Participants in survival [ Time Frame: one year ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Fludarabine and Cytarabine Versus High-dose Cytarabine for CBF-AML
• Official Title: Fludarabine and Cytarabine Versus High-dose Cytarabine in Consolidation Treatment of Core-bing Factor Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Study
• 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Acute Myeloid Leukemia
• Core-Binding Factor

Intervention

• Drug: Fludarabine
  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
  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

Study Arms

• 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 1500mg/m2/d for 5 days intravenously.
  Intervention: Drug: Fludarabine
• Active Comparator: high-dose cytarabine
  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.
  Intervention: Drug: Cytarabine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 5, 2016): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2020
• Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02926586
• Other Study ID Numbers: CBF-AML-2016
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Xianmin Song, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Study Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborators: Not Provided

Investigators

• Principal Investigator: Xianmin Song, Doctor; Department of hematology, Shanghai General Hospital, No. 100 Haining Road, Shang

• PRS Account: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Verification Date: April 2018