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Arsenic Trioxide

Tretinoin + Arsenic Trioxide for Acute Promyelocytic Leukemia

Phase 3
Waitlist Available
Led By Matthew A Kutny
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If the RQ-PCR results are known at the time of study enrollment, the patient must demonstrate the PML-RARalpha transcript by RQ-PCR to be eligible
Patients must be newly diagnosed with a clinical diagnosis of APL (initially by morphology of bone marrow or peripheral blood)
Must not have
Patients with a baseline QTc of > 450 msec are excluded; Bazett's formula is to be used for measurement of the corrected QT interval: the QT interval (msec) divided by the square root of the RR interval (msec)
Patients with a history or presence of significant ventricular or atrial tachyarrhythmia are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment to 4 years
Awards & highlights

Summary

This trial is studying tretinoin and arsenic trioxide to treat patients with newly diagnosed acute promyelocytic leukemia. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by stopping them from spreading.

Who is the study for?
This trial is for patients newly diagnosed with acute promyelocytic leukemia (APL), confirmed by bone marrow or blood tests, and who have the PML-RARalpha transcript. They can't have had previous APL treatments except certain steroids, hydroxyurea, or up to 5 days of ATRA. Pregnant women, breastfeeding mothers, those with heart issues like prolonged QT syndrome or significant arrhythmias are excluded.
What is being tested?
The study is testing tretinoin and arsenic trioxide as a treatment for new acute promyelocytic leukemia cases. It aims to see if this combination reduces long-term side effects compared to traditional chemotherapy drugs known as anthracyclines that can affect the heart.
What are the potential side effects?
Potential side effects include skin reactions from tretinoin and toxicity from arsenic trioxide which may cause headaches, fatigue, nausea, vomiting; there's also a risk of heart problems due to changes in electrolytes affecting the heartbeat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My test shows I have the PML-RARalpha gene change.
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I have been newly diagnosed with APL based on blood or bone marrow tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart's electrical cycle length is within a safe range.
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I do not have a history of serious irregular heartbeats.
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I do not have APL caused by previous cancer treatments.
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I am not pregnant and do not plan to become pregnant during the treatment.
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I agree to use two forms of contraception or remain abstinent during and for 1 month after treatment.
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I do not have a history of prolonged QT syndrome.
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My kidney function is good; I'm not on dialysis nor is my creatinine > 3.0 mg/dL.
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I haven't had chemotherapy before starting this trial, except as previously allowed.
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I do not have APL, but I have a type of leukemia that affects my skin or other areas outside my bone marrow.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of treatment to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
EFS in High Risk APL Patients
Acute Promyelocytic Leukemia
Other study objectives
Change in Adaptive Functioning, Defined by Declines on the Adaptive Behavior Assessment System-II General Adaptive Behavior Composite Score
Change in CogState Scores, Defined as a Decline of 5 Units in Mean Scores Apparent at 2 Years Off Therapy
Change in Intellectual Functioning, Defined by Declines on the Wechsler-derived Estimated Intelligence Quotient and Processing Speed Scores
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (tretinoin, arsenic trioxide, chemotherapy)Experimental Treatment9 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3330
Dexamethasone
2007
Completed Phase 4
~2640
Tretinoin
2013
Completed Phase 4
~2040
Idarubicin
2014
Completed Phase 4
~4330
Mitoxantrone Hydrochloride
2016
Completed Phase 3
~650
Arsenic Trioxide
2011
Completed Phase 3
~240

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
457 Previous Clinical Trials
239,672 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,842 Total Patients Enrolled
Matthew A KutnyPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials

Media Library

Arsenic Trioxide (Arsenic Trioxide) Clinical Trial Eligibility Overview. Trial Name: NCT02339740 — Phase 3
Acute Promyelocytic Leukemia Research Study Groups: Treatment (tretinoin, arsenic trioxide, chemotherapy)
Acute Promyelocytic Leukemia Clinical Trial 2023: Arsenic Trioxide Highlights & Side Effects. Trial Name: NCT02339740 — Phase 3
Arsenic Trioxide (Arsenic Trioxide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02339740 — Phase 3
~16 spots leftby Sep 2025
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