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

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

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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Core-Binding Factor Drug: Fludarabine Drug: Cytarabine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fludarabine and Cytarabine Versus High-dose Cytarabine in Consolidation Treatment of Core-bing Factor Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Study
Study Start Date : July 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020


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 1500mg/m2/d for 5 days intravenously.
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

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.
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 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02926586


Contacts
Contact: Xianmin Song, Doctor 86-21-63240090-3932 shongxm@sjtu.edu.cn

Locations
China, Shanghai
Xianmin Song Recruiting
Shanghai, Shanghai, China, 200080
Contact: Xianmin Song, Doctor    86-21-63240090-3932    shongxm@sjtu.edu.cn   
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Xianmin Song, Doctor Department of hematology, Shanghai General Hospital, No. 100 Haining Road, Shang

Responsible Party: Xianmin Song, professor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02926586     History of Changes
Other Study ID Numbers: CBF-AML-2016
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018

Keywords provided by Xianmin Song, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
RUNX1-RUNX1T1
CBFβ-MYH11
fludarabine
cytarabine

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Fludarabine
Fludarabine phosphate
Cytarabine
Vidarabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents