Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formu… (NCT02899169) | Clinical Trial Compass
UnknownPhase 3
Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formula (RIF)
China110 participantsStarted 2016-09-01
Plain-language summary
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.
Who can participate
Age range14 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age 14 to 70 years
* Newly diagnosed APL with t(15;17)(q22;q12)
* Before treatment the Peripheral blood white blood cell count≤10×109/L
* Patients who can complete the entire treatment process
* Patients or their families signed written informed consent
Exclusion Criteria:
* 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
What they're measuring
1
Disease-free survival (DFS)
Timeframe: At 2 years
Trial details
NCT IDNCT02899169
SponsorFirst Affiliated Hospital Xi'an Jiaotong University