An interventional study of Etoposide and Daunorubicin in Acute Promyelocytic Leukemia, Induction Therapy and Oral, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
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.
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.
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This study's planned enrollment of 74 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
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Exclusion Criteria:
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.
Drug: Etoposide
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).
Drug: Daunorubicin
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.
Also known as: all-trans retinoic acid, realgar-indigo naturalis formula
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).
Also known as: all-trans retinoic acid, realgar-indigo naturalis formula
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
Time frame: 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
Time frame: At the end of induction therapy within 45 days after diagnosis
Early death (ED)
Defined as death within 30 days after diagnosis
Time frame: During the induction therapy within 30 days after diagnosis
Cumulative recurrence rate
A measure of the total relapse that a certain event will happen during a given period of time
Time frame: 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
The EFS was defined as the time from diagnosis to the following events: no haematological CR after induction therapy; no CMR after consolidation therapy, molecular relapse, haematological relapse; death from any cause; or last follow-up.
Time frame: 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.
Toxic effects were graded according to the 'WHO classification standard for acute and subacute toxicity of anticancer drugs'.
Time frame: From the time of randomization to the time of last follow-up within 2years after diagnosis
Plan to share: No
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Peking University People's Hospital