Frontline Oral Arsenic Trioxide-based Induction in Newly Diagnosed Acute Promyelocytic Leukaemia in Adults - a Multicentre Phase 2 Study
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- STATUS
- Recruiting
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- End date
- Jun 30, 2026
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- participants needed
- 100
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- sponsor
- The University of Hong Kong
Summary
The investigators have formulated an oral preparation of As2O3 (oral-As2O3), and shown that it is efficacious for APL in R1, inducing CR2 in more than 90% of patients [8,9]. Furthermore, in an effort to prevent relapse, the investigators have moved oral-As2O3 forward to the maintenance of CR1. This strategy results in favorable overall-survival (OS) and leukemia-free-survival (LFS) [10], implying that prolonged treatment with oral-As2O3 may prevent relapses.
Current protocols have incorporated i.v.-As2O3 in the treatment of newly-diagnosed APL [11-15]. For regimens comprising As2O3, ATRA and chemotherapy, 5-year OS in excess of 90% is achieved [11-15].
The investigators have also published long-term data showing the use of oral-As2O3 is highly effective and safe in the relapsed and frontline settings [16,17].
In this study, the investigators evaluate the use of oral-As2O3 and ATRA based induction regimens in newly diagnosed patients with APL with no of minimal chemotherapy in a prospective multicentre phase 2 study.
Description
After initial eligibility screening, patients will be recruited to oral arsenic trioxide, all-trans-retinoic acid, ascorbic acid (AAA) based-induction for 42 days. Daunorubicin (50mg/m^2/day for 3 days) will only be used during induction in patients <65 with presenting white blood cell count (WBC) ≥ 10 x 10^9/L. In patients not receiving daunorubicin, hydroxyurea (2-4g/day) if WBC ≥ 5 x 10^9/L within the first 14 days of induction. Molecular monitoring monitoring with RQ-PCR or ddPCR for PML-RARA will be performed weekly during induction. A reassessment bone marrow aspirate will be performed on day 28 of induction for assessment of morphologic remission.
Four weeks after the completion of induction phase, all patients, regardless of initial WBC, will receive two cycles of chemotherapy-free AAA consolidation (14 days every 28 days).
Four weeks after completion of consolidation, all patients will receive 12 cycles of chemotherapy-free AAA maintenance (14 days every 8 week).
Molecular monitoring monitoring with RQ-PCR or ddPCR for PML-RARA will be performed during every 4 weeks during consolidation, every 8 weeks during maintenance, and every 3 months for 24 months after completion of maintenance.
Details
| Condition | Acute Promyelocytic Leukemia |
|---|---|
| Treatment | Oral Arsenic Trioxide Formulation |
| Clinical Study Identifier | NCT04687176 |
| Sponsor | The University of Hong Kong |
| Last Modified on | 21 October 2022 |
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