Combined Retinoic Acid,Arsenic Trioxide and Chemo for Newly-diagnosed APL
Conditions
Acute Promyelocytic Leukemia
Conditions: official terms
Leukemia, Promyelocytic, Acute
Conditions: Keywords
arsenic, acute promyelocytic leukemia, outcome
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ATRA+arsenic Type: Drug
Name: ATRA+chemo Type: Drug
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: 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
Location
Department of Hematology
Shanghai, China
Status: Recruiting
Contact: Jiong HU - hujiong@medmail.com.cn
Start Date
October 2012
Completion Date
October 2017
Sponsors
Shanghai Jiao Tong University School of Medicine
Source
Shanghai Jiao Tong University School of Medicine
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page