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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
Bone marrow is highly preferred but in cases where marrow cannot be obtained at diagnosis, peripheral blood will be accepted
Patients may receive up to a maximum of 5 days of pre-treatment with ATRA prior to administration of protocol therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment to 4 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 sample for testing will come from bone marrow, but if not possible, blood will be used.
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I may have taken ATRA for up to 5 days before starting the study treatment.
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My test shows I have the PML-RARalpha gene change.
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I don't need a lumbar puncture to join the study, even if I have CNS symptoms.
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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.
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I have been newly diagnosed with APL based on blood or bone marrow tests.
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I may have taken hydroxyurea, steroids, or intrathecal cytarabine before starting this treatment.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
EFS in High Risk APL Patients
Acute Promyelocytic Leukemia
Other outcome measures
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
~3310
Dexamethasone
2007
Completed Phase 4
~2590
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
453 Previous Clinical Trials
237,242 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,488 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Why is Mitoxantrone Hydrochloride most often prescribed?

"Mitoxantrone Hydrochloride is frequently employed to treat ophthalmia and sympathetic. Additionally, it has shown to be effective in treating branch retinal vein occlusion, macular edema, and communicable diseases."

Answered by AI

Has Mitoxantrone Hydrochloride received government approval for use?

"There is some evidence, from both efficacy trials and multiple rounds of safety testing, that supports the use of Mitoxantrone Hydrochloride. Consequently, it received a score of 3."

Answered by AI

What is the total number of hospitals currently running this trial?

"At present, there are 100 clinical trial sites enrolling patients for this study. The sites are located in New york, Hershey, West Palm Beach, and 100 other locations. If you enroll in the study, it is helpful to select a site that is closest to you in order to minimize travel demands."

Answered by AI

Who would this trial be most beneficial for?

"Up to 158 patients that have been diagnosed with promyelocytic leukemia, acute, between the ages of 12 months and 21 years old, will be accepted into this clinical trial. Most importantly, patients must meet the following criteria: Bone marrow is highly preferred but in cases where marrow cannot be obtained at diagnosis, peripheral blood will be accepted, Patients may receive up to a maximum of 5 days of pre-treatment with ATRA prior to administration of protocol therapy, Treatment with hydroxyurea, corticosteroids (any route) and intrathecal cytarabine prior to beginning protocol directed therapy is allowed; however, it"

Answered by AI

Does this trial allow people who are over the age of 20 to participate?

"In order to take part in this particular clinical trial, enrollees must be between 12 months and 21 years old. Out of the 572 trials available for children, this is one of 1849 trials for people over the age of 65."

Answered by AI
~16 spots leftby Mar 2025