Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) with ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)
Arsenic Trioxide,ATRA,Gemtuzamab Ozogamicin
If you are reading and signing this form on behalf of a potential participant, please note: Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if the combination of all-trans retinoic acid (ATRA), arsenic trioxide (ATO), and gemtuzumab ozogamicin (GO) can help to control acute promyelocytic leukemia (APL). The safety of this drug combination will also be studied.
Disease Group: Leukemia
Treatment Agent: Arsenic Trioxide,ATRA,Gemtuzamab Ozogamicin
Treatment Location: Both at MDACC & and Other Sites
Sponsor: Pfizer, Inc.
Assess whether (a) a combination of all-trans retinoic acid (ATRA), and arsenic trioxide (ATO) can produce long-term event-free survival in patients with low-risk untreated acute promyelocytic leukemia (APL) (b) administration of (GO) at the diagnosis in patients with high-risk APL (WBC > 10,000) and if the WBC rises to > 10,000 after start of treatment (in patients with low-risk disease) will improve CR rate without increasing toxicity in high-risk untreated APL.
IRB Review and Approval Date: 10/05/2011
Recruitment Status: Open
Projected Accrual: 100
1) A diagnosis of APL based on the presence of the PML-RAR-alpha fusion
gene by cytogenetics, PCR, or POD test.
2) 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.
3) 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).
4) Patients age 10 years and older are eligible.
5) 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.
6) 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.
1) QTcF interval on the EKG greater than 480 milliseconds.
2) Patients with creatinine > 2.5 and total bilirubin >/= 2.0 and ALT/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.