Brief Title
Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formula (RIF)
Official Title
Treatment of Non-high-risk Acute Promyelocytic Leukemia With Realgar-Indigo Naturalis Formula (RIF) and All-trans Retinoid Acid (ATRA)
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Disease-free survival (DFS)
Secondary Outcome
Rate of overall survival (OS)
Condition
Acute Promyelocytic Leukemia
Intervention
Realgar-Indigo naturalis formula
Study Arms / Comparison Groups
Oral Realgar-Indigo naturalis formula(RIF) Group
Description: Induction therapy: ATO and ATRA, which will maintain until complete hematologic remission. Hydroxyurea should be administrated until WBC count decrease <10x109/L. Consolidation therapy: RIF（60mg/kg/d) and ATRA 4 weeks on and 2 weeks off, until the fusion gene expression is negative. Maintenance therapy: RIF and ATRA 2 weeks on and 2 weeks off for a total of 6 courses.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
110
Start Date
September 1, 2016
Completion Date
November 1, 2022
Primary Completion Date
September 1, 2022
Eligibility Criteria
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
Gender
All
Ages
14 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Huaiyu Wang, Dr., 15809207527, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02899169
Organization ID
XJTU1AF2016LSL-017
Responsible Party
Sponsor
Study Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Tang-Du Hospital
Study Sponsor
Huaiyu Wang, Dr., Study Chair, First Affiliated Hospital Xi'an Jiaotong University
Verification Date
August 2021