Combined Retinoic Acid,Arsenic Trioxide and Chemo for Newly-diagnosed APL
Information source: Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Promyelocytic Leukemia
Intervention: ATRA+arsenic (Drug); ATRA+chemo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Shanghai Jiao Tong University School of Medicine Official(s) and/or principal investigator(s):
Jun-min Li, M.D, Principal Investigator, Affiliation: Department of Hematology, Rui Jin Hospital, Shanghai JiaoTong University School of Medicine
Overall contact:
Jiong HU, Email: hujiong@medmail.com.cn
Summary
In this prospective randomized study for patients with newly diagnosed acute promyelocytic
leukemia, patients will be randomized into two groups which received retinoic acid and
arsenic trioxide based treatment versus retinoic acid and chemotherapy based regimen.
Clinical Details
Official title: Combined Retinoic Acid,Arsenic Trioxide and Chemotherapy for Newly-diagnosed Acute Promyelocytic Leukemia: Chinese National Multi-center Randomized Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: disease free survival
Secondary outcome: overall survival
Detailed description:
In this prospective randomized study for patients with newly diagnosed acute promyelocytic
leukemia. For induction, all patients will be randomized into two groups which received
treatment composed of retinoic acid combined with arsenic trioxide versus retinoic acid
combined with chemotherapy. For consolidation, the experimental group recieved 2 cycles of
ATRA+arsenic and control group recieved two cycles of ATRA+idarubicin or daunorubicin. After
consolidation, all patients achieved molecular remission will recieved 5 cycles of
maintenance treatment with ATRA and arsenic. In case of intermediate or high-risk disease,
cytarabine will be add for consolidation.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- newly-diagnosed patients with acute promyelocytic leukemia via cytogenetics and
molecular assay
- Age: 18-65
- Hepatic/renal function: Bil≤35μmol/L，AST/ALT less than 2Xnormal range, Cr 150μmol/L
- Normal cardial function
- Informed consent
Exclusion Criteria:
- Relapsed patients
- Known history of arsenic allergy
- QT interval >450ms
- Other malignanct disease
- Pregnant patients
- Patients with mental illness
Locations and Contacts
Jiong HU, Email: hujiong@medmail.com.cn
Department of Hematology, Shanghai 200025, China; Recruiting
Jiong HU, Email: hujiong@medmail.com.cn
Jun-min Li, M.D, Principal Investigator
Additional Information
Starting date: October 2012
Last updated: November 26, 2014
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