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Trial Title:
Optimum Induction Therapy of Low-risk APL
NCT ID:
NCT05832320
Condition:
Acute Promyelocytic Leukemia
Induction Therapy
Oral
Conditions: Official terms:
Leukemia
Leukemia, Promyelocytic, Acute
Etoposide
Daunorubicin
Tretinoin
Conditions: Keywords:
Acute Promyelocytic Leukemia
low risk
induction therapy
etoposide
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Etoposide
Description:
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.
Arm group label:
Oral etoposide with dual induction of ATRA and RIF
Other name:
all-trans retinoic acid
Other name:
realgar-indigo naturalis formula
Intervention type:
Drug
Intervention name:
Daunorubicin
Description:
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).
Arm group label:
Daunorubicin with dual induction of ATRA and RIF
Other name:
all-trans retinoic acid
Other name:
realgar-indigo naturalis formula
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.
Detailed description:
Despite the high cure probability for low-risk acute promyelocytic leukemia (APL) in the
all-trans retinoic acid (ATRA) era, several clinical problems lead to treatment failure,
including early death (ED) and relapse. Previously studies by our group and others showed
a relapse of 1.0-4.8% for low-risk APL, and the median time to hematological relapse was
20.5 months after a hematological complete remission (CR). Dur to the largely unclear
mechanisms of relapse, the investigators previously explored that a drop of promyelocytic
leukemia retinoic acid receptor alpha (PML-RARA) transcript level at the end of induction
therapy was associated with a subsequent risk of relapse. The investigators and others
have indicated that the addition of cytarabine in induction therapy might correlate with
lower relapse rate. Whether cytoreduction in induction therapy has prognostic
significance in APL, besides its role in leukocytosis, remains unclear. Etoposide is a
topoisomerase II inhibitor antitumor agent which is widely used in the treatment of
several hematological malignancies. The successful experience in high-risk APL
demonstrated the efficacy, safety and convenience of oral etoposide as an alternative
cytoreductive agent at the initial stage of induction therapy. Therefore, the present
prospective study is conducted to explore the potential role of cytoreduction during
induction therapy on prognosis, and further exploit the all-oral induction regimen for
low-risk APL with etoposide combined with ATRA plus RIF as the front-line therapy for
low-risk APL.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Newly diagnosed APL patients (WHO 2008 diagnostic classification);
- 18-75 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.
Exclusion Criteria:
- 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;
- Other conditions that the researchers think are not suitable for inclusion.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Institute of Hematology
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaolu Zhu, Doctor
Phone:
8610-82816999
Phone ext:
8033
Email:
zhuxl0614@163.com
Start date:
January 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05832320
