The investigators design a multicenter randomized controlled trial to prove that RIF plus
ATRA is possibly superior to ATO plus ATRA as consolidation and maintenance treatment for the
patients with non-high-risk APL.
Drug: Realgar-Indigo naturalis formula
Drug: all-trans retinoic acid
Drug: Arsenic trioxide
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Full eligibility criteria for NCT02899169
Ages eligible for Study
14 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
age 14 to 70 years
Newly diagnosed APL with t(15;17)(q22;q12)
Before treatment the Peripheral blood white blood cell count＜40×109/L
Patients who can complete the entire treatment process
Patients or their families signed written informed consent
Be allergic to the drug ingredient, the supplementary material or the allergic constitution person
Cardiac insufficiency, renal insufficiency, significant arrhythmias, EKG abnormalities or other important organ dysfunction
Combined with other malignant tumors
Pregnant and lactating women
Participants in other drug trials in the last 3 months
Suffering from mental illness or other circumstances which unable to carry out the plan
Other patients who were not suitable for the study
All locations for NCT02899169
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710016
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View full eligibility
Tris trial is registered with FDA with number: NCT02899169. The sponsor of the trial is First Affiliated Hospital Xi'an Jiaotong University and it is looking for 110 volunteers for the current phase.
Official trial title: Treatment of Non-high-risk Acute Promyelocytic Leukemia With Realgar-Indigo Naturalis Formula (RIF) and All-trans Retinoid Acid (ATRA)
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