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Tretinoin and Arsenic Trioxide for Acute Promyelocytic Leukemia

This study is looking at how well a combination of drugs works for people with newly diagnosed acute promyelocytic leukemia (APL). The drugs being tested are tretinoin (a form of vitamin A), arsenic trioxide, and gemtuzumab ozogamicin. Tretinoin and arsenic trioxide are chemotherapy drugs that stop cancer cells from growing. Gemtuzumab ozogamicin is an immunotoxin that targets and kills cancer cells. Researchers want to see if adding gemtuzumab ozogamicin to tretinoin and arsenic trioxide can kill more cancer cells. To join, you must have an APL diagnosis confirmed by a specific genetic test (PML-RAR-alpha fusion gene). The main goal is to see how long people live without their disease coming back or getting worse. This study is currently unclear on its recruitment status and plans to enroll 151 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 151 participants.
What's involved
Participants will receive tretinoin by mouth and arsenic trioxide by IV daily for four weeks during induction. Some participants will also receive gemtuzumab ozogamicin by IV once during induction. After induction, participants will receive consolidation treatment for up to four courses.
Compensation
Not stated in the trial record.
Follow-up
After treatment, participants will be followed up every 6-12 months. The main goal of the study is measured up to 2 years after treatment starts.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01409161

Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

Recruiting
PHASE2Ages 10+InterventionalTreatment
M.D. Anderson Cancer Center
~151 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Arsenic TrioxideGemtuzumab OzogamicinLaboratory Biomarker AnalysisTretinoin

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event free survival
Measured over The time from the start of treatment to first documentation of disease relapse or death, assessed up to 2 years

Conditions

Acute Promyelocytic Leukemia With PML-RARA

Explore related trials

Acute Promyelocytic LeukemiaPML/RARA Fusion Gene

NCT01409161

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • M D Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • MD Anderson Regional Care Center-Bay Area

    Nassau Bay, Texasstudy coordinator listed

    Recruiting

  • MD Anderson Regional Care Center-Katy

    Houston, Texasstudy coordinator listed

    Recruiting

  • MD Anderson Regional Care Center-Sugar Land

    Sugar Land, Texasstudy coordinator listed

    Recruiting

  • MD Anderson Regional Care Center-The Woodlands

    The Woodlands, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Farhad Ravandi-Kashani · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Farhad Ravandi-Kashani
[email protected]
713-745-0394
Email the study team

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Eligibility criteria

Inclusion

A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, polymerase chain reaction (PCR), or POD test
Ability to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of the study
Patients in whom therapy for APL was initiated on an emergent basis are eligible (patients may have already started treatment with ATRA, ATO, and/or one dose of idarubicin due to the urgency to start therapy early)
Women of child-bearing potential must have a negative serum pregnancy test at screening; in addition to having a negative pregnancy test confirmed at screening, all female participants of childbearing potential must have a negative pregnancy test confirmed within 48 hours prior to dosing with the study drug
All sexually active subjects (males and females of child-bearing potential) agree to use 2 effective methods of contraception for the duration of the study

Exclusion

Fridericia corrected QT (QTcF) interval on the electrocardiogram (EKG) greater than 480 milliseconds
Patients with creatinine \> 2.5 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease
Patients with total bilirubin \>= 2.0 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease
Patients with alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \> 3 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease

What this trial measures

  • Event free survivalThe time from the start of treatment to first documentation of disease relapse or death, assessed up to 2 years

    Monitored using a Bayesian time-to-event model.