Optimum Induction Therapy of Low-risk APL
1 other identifier
interventional
74
1 country
1
Brief Summary
Despite the high cure probability for acute promyelocytic leukemia (APL), a minority of patients will relapse and the risk factors for relapse are unclear. The goal of this clinical trial is to compare the effectiveness and safety of induction of oral all-trans retinoic acid (ATRA) and realgar-indigo naturalis formula (RIF) combined with oral etoposide or daunorubicin as cytoreductive therapies in low-risk APL. The present study was to explored a cytoreduction of an oral etoposide for low-risk APL with dual induction of ATRA and RIF as a high efficacy, low recurrence, and more convenient all-oral regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 2, 2023
CompletedFirst Posted
Study publicly available on registry
April 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMay 10, 2024
May 1, 2024
2 years
April 2, 2023
May 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Complete remission
Haematological CR was defined as a proportion of BM blasts of \<5%, the absence of blasts in Auer rods, the absence of extramedullary disease, an absolute neutrophil count of \>1×10⁹/L and a platelet count of \>100×109/L, with no red-cell transfusions
At the end of induction therapy within 45 days after diagnosis
Promyelocytic leukaemia-retinoic acid receptor alpha (PML-RARA) transcript levels of ≥6.5% at the end of induction therapy
PML-RARA transcripts using Abelson tyrosine-protein kinase (ABL) as an internal control by quantitative RT-PCR
At the end of induction therapy within 45 days after diagnosis
Secondary Outcomes (4)
Early death (ED)
During the induction therapy within 30 days after diagnosis
Cumulative recurrence rate
From date of randomization until the date of last documented progression or date of death from any cause, whichever came first, assessed up to 2 years
2-year event-free survival rate
From the time of randomization to the time of last follow-up within 2 years after diagnosis
Satefy. Common haematological and non-haematological adverse events were monitored twice per week during induction and twice per month during consolidation.
From the time of randomization to the time of last follow-up within 2years after diagnosis
Study Arms (2)
Oral etoposide with dual induction of ATRA and RIF
EXPERIMENTALRIF: 60mg/kg qd, ATRA: 25mg/m2 qd, till CR. When WBC\>4.0×109/L, patients will be given oral etoposide (50mg qd to 50mg tid). Cumulative dosage of etoposide during induction ≤1500mg.
Daunorubicin with dual induction of ATRA and RIF
ACTIVE COMPARATORRIF: 60mg/kg qd, ATRA: 25mg/m2 qd, till CR. When WBC\>4.0×109/L, patients will be given daunorubicin (20 to 40mg per dose).
Interventions
Introduction: RIF: 60mg/kg qd, ATRA: 25mg/m2 qd, till CR. When WBC\>4.0×109/L, patients will be given oral etoposide (50mg qd to 50mg tid). Cumulative dosage of etoposide during induction ≤1500mg.
Introduction: RIF: 60mg/kg qd, ATRA: 25mg/m2 qd, till CR. When WBC\>4.0×109/L, patients will be given daunorubicin (20 to 40mg per dose).
Eligibility Criteria
You may qualify if:
- Newly diagnosed APL patients (WHO 2008 diagnostic classification);
- years old;
- Liver function: propionate hydrogentransferase (ALT) and aspartate hydrogentransferase (AST) ≤ 2.5 times the upper limit of normal value, bilirubin ≤ 2 times the upper limit of normal value;
- Renal function: muscle salt ≤ 3 times the upper limit of normal value;
- The physical strength score is 0-2 (ECOG);
- White blood cells ≤ 10×109/L;
- Subjects must sign an informed consent form.
You may not qualify if:
- Subjects who have participated in other clinical trials within 30 days;
- Pregnant and lactating subjects;
- Subjects who are known to be HIV-positive in serological tests;
- Subjects who have viral hepatitis serological test positive;
- Subjects who have severe arrhythmia, abnormal electrocardiogram (QT\>500ms);
- Subjects who suffer from mental illness or unable to cooperate with the research treatment and monitoring requirements due to other diseases;
- Subjects who participate in other clinical research at the same time;
- Subjects who fail to sign the informed consent form;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Institute of Hematology
Beijing, Beijing Municipality, 100044, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaolu Zhu, Doctor
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician-in-charge
Study Record Dates
First Submitted
April 2, 2023
First Posted
April 27, 2023
Study Start
January 1, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
May 10, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share