Randomized,International Multi-center Clinical Trial of RIF Plus RA for Non-high-risk APL
RIF
Implement Randomized, Controlled, International Multi-center Clinical Trial of Compound Realgar-Indigo Naturalis Formula Plus Retinoic Acid for Non-high-risk Acute Promyelocytic Leukaemia
1 other identifier
interventional
109
0 countries
N/A
Brief Summary
Acute Promyelocytic Leukaemia (APL) has been known as a type of cancer, which is of great significance to improve its eradication rate. Recent clinical trials show that ATRA plus ATO treatment regimen can result in complete response (CR) in 90-94% of patients and 5-year disease-free survival (DFS) in more than 90% of patients. However, the ATRA plus ATO treatment regimen can achieve considerate survival rate, patients still need to receive infusion therapy in hospital. If oral arsenic can replace intravenous ATO without reduction of the efficacy, patients would not need to be administered to receive treatment, which would highly increase their quality of lives. Phase I, II Clinical trials have verified the security and efficacy of the Compound Realgar-Indigo Naturalis Formula. Compound Realgar-Indigo Naturalis Formula was approved by the China Food and Drug Administration in 2009. Investergators have done a multi-centre, randomized, controlled, non-inferiority phase 3 clinical trial in China. And the result showed that oral arsenic plus retinoic acid has an anti-leukaemic efficacy similar to the intravenous arsenic treatment. So Investigators performed an international multi-center, Randomized controlled clinical trialsto compare the efficacy of oral RIF plus ATRA with intravenous arsenic trioxide plus ATRA in patients with non-high-risk APL in different racial types.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2019
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2019
CompletedFirst Posted
Study publicly available on registry
November 25, 2019
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedNovember 29, 2019
November 1, 2019
1.8 years
November 21, 2019
November 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
2-year Event-free Survival (EFS) rate
treatment failure (no CR after 45-day induction therapy, or no molecular complete remission after 3-month consolidation therapy), relapse (molecular relapse, or haematological relapse); or death from any cause.
2 year after diagnosis
Study Arms (2)
Compound Realgar-Indigo Naturalis Formula Plus Retinoic Acid
EXPERIMENTALInduction: a) RIF: 60 mg/kg daily until CR, b) ATRA: 25 mg/m² daily until CR; Consolidation: a) RIF: 60 mg/kg daily, in a 4-week on 4-week off regimen for four cycles in a 4-week on 4-week off regimen for four cycles b) ATRA: 25 mg/m² daily, in a 2-week on 2-week off regimen for seven cycles
Arsenic trioxide Plus Retinoic Acid
OTHERInduction: a) Arsenic trioxide: 0·15 mg/kg daily until CR, b) ATRA: 25 mg/m² daily until CR Consolidation: a) Arsenic trioxide: 0.15mg/kg daily, in a 4-week on 4-week off regimen for four cycles b) ATRA: 25 mg/m² daily, in a 2-week on 2-week off regimen for seven cycles Expected Efficacy: Oral RIF plus ATRA is not inferior to intravenous arsenic trioxide plus ATRA for achieving 2-year EFS.
Interventions
Randomization is done centrally according to trial centers Eligible patients are randomly assigned (2:1) to the Treatment Group or the Control Group, with a 24-month follow-up.
Eligibility Criteria
You may qualify if:
- Newly diagnosed APL patient (with WHO performance status)
- Age 18-70
- ALT and AST of maximum 2·5 times the ULN, and bilirubin concentration of maximum two times the ULN
- Creatinine concentration of maximum three times the ULN
- Performance status of 0-2 grade (ECOG)
- WBC ≤ 10 x 109/L before the treatment
- Informed Consent Paper signed
You may not qualify if:
- Cerebral hemorrhage
- Pregnancy
- Concomitant severe psychiatric condition or anything else against the fulfillment of the plan
- Clinically significant arrhythmias or electrocardiogram abnormalities (QT\>500ms)
- Refusal to sign off the Informed Consent Paper
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiao-Jun Huang, MD
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Hematology Department
Study Record Dates
First Submitted
November 21, 2019
First Posted
November 25, 2019
Study Start
December 1, 2019
Primary Completion
August 31, 2021
Study Completion
August 31, 2023
Last Updated
November 29, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share