Frontline Oral Arsenic Trioxide for APL

PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 1, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2026

Conditions
Acute Promyelocytic Leukemia
Interventions
DRUG

Oral Arsenic Trioxide Formulation

"Patients will be recruited to oral arsenic trioxide, all-trans-retinoic acid, ascorbic acid (AAA) based-induction for 42 days. Daunorubicin or idarubicin 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 if WBC ≥ 5 x 10\^9/L within the first 14 days of 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)."

Trial Locations (2)

Unknown

RECRUITING

The University of Hong Kong, Hong Kong

RECRUITING

National University Hospital Singapore, Singapore

All Listed Sponsors
lead

The University of Hong Kong

OTHER