Combining tretinoin and arsenic trioxide with or without gemtuzumab ozogamicin for treating acute promyelocytic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effectiveness of a combination treatment using tretinoin and arsenic trioxide, with the option of adding gemtuzumab ozogamicin, for patients with previously untreated acute promyelocytic leukemia (APL). The study aims to determine if this combination can lead to long-term event-free survival in low-risk patients and improve response rates in high-risk patients without increasing toxicity. Participants will receive these treatments over a specified schedule, followed by consolidation therapy for those who achieve a complete response. The trial includes regular follow-ups to monitor patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting
• MD Anderson Regional Care Center-Katy
  Houston, Texas, United States Recruiting
• MD Anderson Regional Care Center-Bay Area
  Nassau Bay, Texas, United States Recruiting
• MD Anderson Regional Care Center-Sugar Land
  Sugar Land, Texas, United States Recruiting
• MD Anderson Regional Care Center-The Woodlands
  The Woodlands, Texas, United States Recruiting

Study contacts

• Principal investigator: Farhad Ravandi-Kashani — M.D. Anderson Cancer Center
• Study coordinator: Farhad Ravandi-Kashani
• Email: fravandi@mdanderson.org
• Phone: 713-745-0394

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.