Status:
COMPLETED
Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Northwestern University
New York Presbyterian Hospital
Conditions:
Acute Promyelocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find what effects, good and/or bad, treatment with two drugs has on leukemia. The first medicine is tretinoin (also called all-trans retinoic acid, ATRA, or Vesanoid). ...
Detailed Description
Induction will consist of tretinoin 45 mg/m2 po daily (rounded up to the nearest 10mg) in two divided doses (25 mg/m2 in patients \<20 years of age) for 35 days and ATO 0.15 mg/kg IV daily for 35 dose...
Eligibility Criteria
Inclusion
- Previously untreated patients with a morphologic diagnosis of APL, confirmed by demonstration of t(15;17) using conventional cytogenetics OR florescence in situ hybridization (FISH), OR a positive RT-PCR assay for PML-RAR at the subject's local institution.
- Age ≥18 years. Karnofsky performance status of ≥ 60%.
- Adequate renal function as demonstrated by a serum creatinine ≤ 2.0 mg/dl or a creatinine clearance of \> 60 ml/min.
- Adequate hepatic function as demonstrated by a bilirubin \< 2.0 mg/dl (unless attributable to Gilbert's disease) and an alkaline phosphatase, AST, and ALT ≤ 2.5 times the upper limit of normal.
- Normal cardiac function as demonstrated by a left ventricular ejection fraction ≥ 50% on echocardiogram or MUGA scan.
- QTc ≤ 500 msec on baseline ECG.
- Negative serum pregnancy test in women of childbearing potential.
- Ability to swallow oral medication.
- Men and women of child-bearing potential must be willing to practice an effective method of birth control during treatment and at least 4 months after treatment is finished.
- Patients with central nervous system involvement by APL are eligible and may receive concomitant treatment with radiation therapy and/or intrathecal chemotherapy in accordance with standard medical practice.
Exclusion
- Previous treatment for APL, except tretinoin, which may be given for up to 7 days prior to study entry.
- Active serious infections not controlled by antibiotics.
- Pregnant women or women who are breast-feeding.
- Concurrent active malignancy requiring immediate therapy.
- Clinically significant cardiac disease (NY Heart Association Class III or IV), including chronic arrhythmias, or pulmonary disease.
- Other serious or life-threatening conditions deemed unacceptable by the principal investigator.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01404949
Start Date
July 1 2011
End Date
February 1 2021
Last Update
November 30 2021
Active Locations (12)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
Northwestern University
Evanston, Illinois, United States, 60208
3
National Heart, Lung, and Blood Institute (NIH)
Bethesda, Maryland, United States, 20824
4
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920