Actively Recruiting
Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
151
Participants Needed
5
Research Sites
845 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute promyelocytic leukemia confirmed by PML-RAR-alpha fusion gene using cytogenetics, PCR, or POD test
- Ability and willingness to sign informed consent acknowledging investigational study nature
- Patients who started emergency therapy for APL, including ATRA, ATO, or one dose of idarubicin, are eligible
- Women of child-bearing potential must have a negative serum pregnancy test at screening and within 48 hours before study dosing
- All sexually active participants of child-bearing potential agree to use two effective contraception methods during the study
You will not qualify if you...
- Corrected QT interval on EKG greater than 480 milliseconds
- Creatinine levels more than 2.5 times the upper normal limit, unless related to leukemia, hemolysis, or Gilbert's disease
- Total bilirubin levels 2.0 times or higher than the upper normal limit, unless related to leukemia, hemolysis, or Gilbert's disease
- ALT or AST levels greater than 3 times the upper normal limit, unless related to leukemia, hemolysis, or Gilbert's disease
AI-Screening
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Trial Site Locations
Total: 5 locations
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
2
MD Anderson Regional Care Center-Katy
Houston, Texas, United States, 77094
Actively Recruiting
3
MD Anderson Regional Care Center-Bay Area
Nassau Bay, Texas, United States, 77058
Actively Recruiting
4
MD Anderson Regional Care Center-Sugar Land
Sugar Land, Texas, United States, 77478
Actively Recruiting
5
MD Anderson Regional Care Center-The Woodlands
The Woodlands, Texas, United States, 77384
Actively Recruiting
Research Team
F
Farhad Ravandi-Kashani
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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