APL16: Treatment of Non-high-risk Acute Promyelocytic Leukemia (APL) With Realgar-Indigo Naturalis Formula (RIF)

Sponsor
First Affiliated Hospital Xi'an Jiaotong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT02899169
Collaborator
Tang-Du Hospital (Other)
110
1
2
74
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Realgar-Indigo naturalis formula
  • Drug: all-trans retinoic acid
  • Drug: Arsenic trioxide
  • Drug: Hydroxyurea
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Non-high-risk Acute Promyelocytic Leukemia With Realgar-Indigo Naturalis Formula (RIF) and All-trans Retinoid Acid (ATRA)
Actual Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Oral Realgar-Indigo naturalis formula(RIF) Group

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.

Drug: Realgar-Indigo naturalis formula
Other Names:
  • RIF
  • Drug: all-trans retinoic acid
    Other Names:
  • ATRA
  • Tretinoin
  • Drug: Hydroxyurea

    Active Comparator: Intravenous Arsenic Trioxide(ATO) Group

    Induction therapy: ATO and ATRA, which will maintain until complete hematologic remission. Hydroxyurea should be administrated until WBC count decrease <10x109/L. Consolidation therapy: ATO and ATRA 4 weeks on and 2 weeks off, until the fusion gene expression is negative. Maintenance therapy: ATO and ATRA 2 weeks on and 2 weeks off for a total of 6 courses.

    Drug: all-trans retinoic acid
    Other Names:
  • ATRA
  • Tretinoin
  • Drug: Arsenic trioxide
    Other Names:
  • ATO
  • Trisenox (R)
  • As2O3
  • Drug: Hydroxyurea

    Outcome Measures

    Primary Outcome Measures

    1. Disease-free survival (DFS) [At 2 years]

    Secondary Outcome Measures

    1. Rate of overall survival (OS) [At 2 years]

    2. Event-free survival [From date of randomization until the date of first documented event, assessed up to 36 months]

    3. Rate of cumulative incidence of relapse (CIR) [assessed up to 3 years after randomization]

    4. Incidence of hematological and non-hematological toxicity [From date of randomization until 2 years]

    5. medical expense [From date of randomization until 2 years]

    6. Total hospitalization days during therapy [At 2 years from study entry]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi China 710016

    Sponsors and Collaborators

    • First Affiliated Hospital Xi'an Jiaotong University
    • Tang-Du Hospital

    Investigators

    • Study Chair: Huaiyu Wang, Dr., First Affiliated Hospital Xi'an Jiaotong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    First Affiliated Hospital Xi'an Jiaotong University
    ClinicalTrials.gov Identifier:
    NCT02899169
    Other Study ID Numbers:
    • XJTU1AF2016LSL-017
    First Posted:
    Sep 14, 2016
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by First Affiliated Hospital Xi'an Jiaotong University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 8, 2021