A Phase 3 interventional study of Oral ATO and IV Arsenic Trioxide in Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia and Acute Promyelocytic Leukemia With PML-RARA, sponsored by SDK Therapeutics, Inc.. Not yet recruiting. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by SDK Therapeutics, Inc. · Phase 3, Interventional, and Treatment
LATITUDE: A Phase 3, Randomized, Open-Label, 3-Cohort, 2-Period, 2- Sequence, Crossover Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Arsenic Trioxide Versus Intravenous Arsenic Trioxide for Consolidation Therapy in Participants With Newly Diagnosed, Non-High Risk, Acute Promyelocytic Leukemia
Rationale:
SDK Therapeutics is developing an oral formulation of arsenic trioxide (ATO) for the treatment of acute promyelocytic leukemia (APL). Patients with APL are usually treated with arsenic trioxide (ATO) through an IV along with all-trans retinoic acid (ATRA) taken by mouth. Receiving ATO through an IV requires patients with APL to go to the hospital a lot and get long treatments (sometimes every day over a year of treatment). This can be hard and uncomfortable. If ATO can be taken by mouth, it would be much easier for patients and their families.
Objective:
The main objective is to show that the body absorbs the same amount of ATO whether it's taken by mouth or through an IV. Other objectives include checking if ATO taken by mouth works just as well, causes fewer heart problems, is safe, and improves quality of life compared with ATO given through an IV.
Main trial endpoints:
The main endpoint being measured is how much ATO is in the blood after 5 doses. Another important endpoint is how many patients have no signs of cancer in their blood after 3 rounds of treatment.
Secondary trial endpoints:
Other things being measured include: whether patients stay cancer-free over 2 years; changes in heart rhythm; side effects and lab test results; how patients feel during treatment; how much of ATO is in the blood; and how often patients feel bothered by side effects.
Trial design:
This is an open-label study, meaning everyone knows which treatment they are getting. Patients will get 4 rounds of treatment, each lasting 8 weeks. After that, patients will have check-ups every 3 months to assess safety and disease status for a total of 2 years.
Trial population:
The study includes adults and teens (12 years and older) who have APL, are not high-risk, and have already finished the first part of their treatment (induction) with IV ATO and ATRA.
Interventions:
There are 3 groups in the study:
Cohort A: Takes 0.15 mg/kg Oral ATO for 3 rounds, then switches to 0.15 mg/kg IV ATO for part of the 4th round.
Cohort B: Takes 0.15 mg/kg IV ATO for 3 rounds, then switches to 0.15 mg/kg Oral ATO for part of the 4th round.
Cohort C: Takes 0.15 mg/kg Oral ATO for all 4 rounds.
All cohorts also take 45 mg/m2/day ATRA during certain weeks of each round. Doctors will assess efficacy by checking bone marrow samples before and during treatment to see if the cancer is gone. Special lab tests will be used to look for cancer cells. Safety will be assessed by checking for side effects using blood tests, heart tests, physical exams, and other health checks. Quality of life will be assessed by the patients who will fill out surveys about how they feel during treatment and how much the side effects bother them. The study will also look at how often patients need to go to the doctor or hospital; how treatment affects daily life and work; and how satisfied patients are with their treatment.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Additional inclusion/exclusion criteria may apply, per protocol.
Participants will receive Oral ATO 0.15 mg/kg daily × 5 days a week from Weeks 1 to 4 in the first three 8-week cycles, IV ATO 0.15 mg/kg daily (2-hour infusion) × 5 days in Week 1 of Cycle 4, and oral ATO 0.15 mg/kg daily × 5 days a week from Weeks 2 to 4 of Cycle 4. All adult participants will receive ATRA 45 mg/m2/day in 2 divided doses as background treatment 7 days a week for 2 weeks on and 2 weeks off (Weeks 1, 2, 5 and 6 of each 8-week cycle) beginning in Cycle 1 and ending after Cycle 4 Week 2
Drug: Oral ATO · Drug: IV Arsenic Trioxide · Drug: all-trans retinoic acid (ATRA)
Participants will receive IV ATO 0.15 mg/kg daily (2-hour infusion) × 5 days a week from Weeks 1 to 4 in the first three 8-week cycles, oral ATO 0.15 mg/kg daily × 5 days in Week 1 of Cycle 4, and IV ATO 0.15 mg/kg daily (2-hour infusion) × 5 days a week from Weeks 2 to 4 of Cycle 4. All adult participants will receive ATRA 45 mg/m2/day in 2 divided doses as background treatment 7 days a week for 2 weeks on and 2 weeks off (Weeks 1, 2, 5 and 6 of each 8-week cycle) beginning in Cycle 1 and ending after Cycle 4 Week 2
Drug: Oral ATO · Drug: IV Arsenic Trioxide · Drug: all-trans retinoic acid (ATRA)
Participants will receive Oral ATO 0.15 mg/kg daily × 5 days a week from Weeks 1 to 4 of four 8-week cycles. All adult participants will receive ATRA 45 mg/m2/day in 2 divided doses as background treatment 7 days a week for 2 weeks on and 2 weeks off (Weeks 1, 2, 5 and 6 of each 8-week cycle) beginning in Cycle 1 and ending after Cycle 4 Week 2
Drug: Oral ATO · Drug: all-trans retinoic acid (ATRA)
Oral Arsenic Trioxide
Intravenous Arsenic Trioxide
all-trans retinoic acid (ATRA)
Pharmacokinetic exposure (amount of ATO in the blood)
Total 5-dose plasma AsIII AUC
Time frame: At the end of Cycle 4, Week 1 (Each cycle is 8 weeks)
Molecular Complete Response (molCR) rate
molCR rate, defined as negative/undetected for PML:RARα by RT-qPCR
Time frame: At the end of 3 Cycles of treatment (each cycle is 8 weeks)
Relapse-Free Survival (RFS)
2-year Relapse Free Survival (RFS)
Time frame: Assessed for up to 2 years after the first dose of treatment, or until disease progression/relapse or death, whichever occurs first.
Change in Fridericia-corrected QT interval (ΔQTcF interval)
Difference in QTcF between collected values
Time frame: At the end of Cycles 3 and 4 (each cycle is 8 weeks)
Adverse events
Frequency, severity, and relatedness of adverse events.
Time frame: Up to 9 months
Cardiac AEs related to elevated QTcF
Number of prolonged QTcF interval or other arrhythmias per CTCAE
Time frame: Up to 9 months
Pharmacokinetic profile
Peak Plasma Concentration (Cmax)
Time frame: At the end of Cycle 4, week 1 (Each cycle is 8 weeks)
Patient Reported Outcomes
Change from baseline as measured by the EORTC QLQ-C30
Time frame: Up to 9 months
Patient Reported Outcomes
Proportion of time "bothered by side-effects" as measured by the FACT-GP5
Time frame: Up to 9 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Leukemia, Promyelocytic, Acute→
SDK Therapeutics, Inc.