What this study is
This phase II trial studies how well tretinoin and arsenic trioxide with or without gemtuzumab ozogamicin works in treating patients with previously untreated acute promyelocytic leukemia. Drugs used in chemotherapy, such as tretinoin and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotoxins, such as gemtuzumab ozogamicin, may find certain cancer cells and kill them without harming normal cells. Giving tretinoin and arsenic trioxide together with gemtuzumab ozogamicin may kill more cancer cells.
What's being tested
- Arsenic Trioxide
Intervention · DRUG
- Gemtuzumab Ozogamicin
Intervention · DRUG
- Laboratory Biomarker Analysis
Intervention · OTHER
Correlative studies
- Tretinoin
Intervention · DRUG
Given PO
Both Arsenic Trioxide and Gemtuzumab Ozogamicin
Given IV
Study details
- Official title
- Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)
- Sponsor
- M.D. Anderson Cancer Center
- Conditions
- Acute Promyelocytic Leukemia With PML-RARA
- Enrolling
- 151 people
- Starts
- 2011-10-05
- Est. completion
- 2027-12-18
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 10 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (5)
5 openContact for every open site
- Farhad Ravandi-Kashani · Contact713-745-0394
- Farhad Ravandi-Kashani · Principal investigator
M D Anderson Cancer Center
Houston, Texas, United States
RecruitingMD Anderson Regional Care Center-Katy
Houston, Texas, United States
RecruitingMD Anderson Regional Care Center-Bay Area
Nassau Bay, Texas, United States
RecruitingMD Anderson Regional Care Center-Sugar Land
Sugar Land, Texas, United States
RecruitingMD Anderson Regional Care Center-The Woodlands
The Woodlands, Texas, United States
Recruiting
Study team
Sponsor
M.D. Anderson Cancer Center
Study ID 2010-0981
Principal investigator
Farhad Ravandi-Kashani
M.D. Anderson Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.