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Tretinoin + Arsenic Trioxide for Acute Promyelocytic Leukemia
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My sample for testing will come from bone marrow, but if not possible, blood will be used.I may have taken ATRA for up to 5 days before starting the study treatment.My test shows I have the PML-RARalpha gene change.I don't need a lumbar puncture to join the study, even if I have CNS symptoms.My sample for testing will come from bone marrow, but if not possible, blood will be used.My test shows I have the PML-RARalpha gene change.I don't need a lumbar puncture to join the study, even if I have symptoms or CNS disease.I have taken hydroxyurea, corticosteroids, or intrathecal cytarabine before starting this treatment plan.My heart's electrical cycle length is within a safe range.I do not have a history of serious irregular heartbeats.I do not have APL caused by previous cancer treatments.I am not pregnant and do not plan to become pregnant during the treatment.I have been newly diagnosed with APL based on blood or bone marrow tests.I agree to use two forms of contraception or remain abstinent during and for 1 month after treatment.I do not have a history of prolonged QT syndrome.I may have taken ATRA for up to 5 days before starting the study treatment.I have been newly diagnosed with APL based on blood or bone marrow tests.My kidney function is good; I'm not on dialysis nor is my creatinine > 3.0 mg/dL.I haven't had chemotherapy before starting this trial, except as previously allowed.I do not have APL, but I have a type of leukemia that affects my skin or other areas outside my bone marrow.I may have taken hydroxyurea, steroids, or intrathecal cytarabine before starting this treatment.
- Group 1: Treatment (tretinoin, arsenic trioxide, chemotherapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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"
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."
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