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

August 31, 2021 updated by: First Affiliated Hospital Xi'an Jiaotong University

Treatment of Non-high-risk Acute Promyelocytic Leukemia With Realgar-Indigo Naturalis Formula (RIF) and All-trans Retinoid Acid (ATRA)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Huaiyu Wang, Dr.
  • Phone Number: 15809207527
  • Email: whymed@126.com

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710016
        • Recruiting
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 66 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: Hydroxyurea
Drug: Realgar-Indigo naturalis formula
Other Names:
  • RIF
Drug: all-trans retinoic acid
Other Names:
  • ATRA
  • Tretinoin
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: Hydroxyurea
Drug: Arsenic trioxide
Other Names:
  • ATO
  • Trisenox (R)
  • As2O3
Drug: all-trans retinoic acid
Other Names:
  • ATRA
  • Tretinoin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival (DFS)
Time Frame: At 2 years
At 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of overall survival (OS)
Time Frame: At 2 years
At 2 years
Event-free survival
Time Frame: From date of randomization until the date of first documented event, assessed up to 36 months
From date of randomization until the date of first documented event, assessed up to 36 months
Rate of cumulative incidence of relapse (CIR)
Time Frame: assessed up to 3 years after randomization
assessed up to 3 years after randomization
Incidence of hematological and non-hematological toxicity
Time Frame: From date of randomization until 2 years
From date of randomization until 2 years
medical expense
Time Frame: From date of randomization until 2 years
From date of randomization until 2 years
Total hospitalization days during therapy
Time Frame: At 2 years from study entry
At 2 years from study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Tang-Du Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

September 4, 2016

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

September 8, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2016LSL-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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