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

Launched by M.D. ANDERSON CANCER CENTER · Aug 2, 2011

Keywords

ClinConnect Summary

This clinical trial is studying a combination of three treatments—tretinoin, arsenic trioxide, and gemtuzumab ozogamicin—for patients who have newly diagnosed acute promyelocytic leukemia (APL). APL is a type of blood cancer, and the goal of the trial is to see if this combination of medications can effectively kill more cancer cells compared to using some of these drugs alone. Tretinoin and arsenic trioxide work by stopping cancer cells from growing, while gemtuzumab ozogamicin targets and kills specific cancer cells without harming healthy ones.

To be eligible for this trial, participants must have a confirmed diagnosis of APL and be willing to sign a consent form to participate. They can be adults of any age, including those who may have already started treatment due to the urgency of their condition. However, there are some health conditions that could prevent someone from joining, such as certain heart issues or high levels of specific liver or kidney tests. Participants in the trial can expect close monitoring and care as they receive these treatments in a supportive environment.

Gender

ALL

Eligibility criteria

• 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