Acute Promyelocytic Leukemia
Conditions
Keywords
Acute promyelocytic leukemia, Realgar-Indigo Naturalis Formula, All-trans Retinoic Acid
Brief 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.
Detailed description
Acute promyelocytic leukemia (APL) is a unique subtype of acute myeloid leukemia (AML) which accounts for 10-15% of acute myeloid leukemia. It is characterized by the PML-RARA fusion gene generated by the t(15;17)(q22;q21) chromosomal translocation. The application of ATRA and ATO, make APL from highly fatal to highly curable. APL0406 study proves that ATRA plus arsenic trioxide is at least not inferior and may be superior to ATRA plus chemotherapy in the treatment of patients with non-high-risk APL. Now, the arsenic trioxide has already became the based regimen as targeted first-line treatment without chemotherapy. A study shows that oral RIF plus ATRA is not inferior to intravenous ATO plus ATRA as maintenance treatment of APL. 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. Application of oral RIF decrease the total hospitalization days.
Interventions
Sponsors
Tang-Du Hospital
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS) | At 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival | From date of randomization until the date of first documented event, assessed up to 36 months |
| Rate of cumulative incidence of relapse (CIR) | assessed up to 3 years after randomization |
| Rate of overall survival (OS) | At 2 years |
| medical expense | From date of randomization until 2 years |
| Total hospitalization days during therapy | At 2 years from study entry |
| Incidence of hematological and non-hematological toxicity | From date of randomization until 2 years |
Countries
China
Contacts
Primary ContactHuaiyu Wang, Dr.
Outcome results
None listed