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Phase II Study of Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy

Phase 2
18 Years
Open (Enrolling)
Acute Promyelocytic Leukemia

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Trial Information

Phase II Study of Combined Tretinoin and Arsenic Trioxide for Patients With Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy

Inclusion Criteria:

- 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

- 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

- 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 Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the rate of molecular remission

Outcome Description:

after induction with combined tretinoin and ATO (along with idarubicin in patients with high-risk disease or who develop leukocytosis) in APL.

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Jae Park, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

July 2011

Completion Date:

July 2015

Related Keywords:

  • Acute Promyelocytic Leukemia
  • Tretinoin
  • all-trans retinoic acid
  • ATRA
  • Vesanoid
  • Arsenic Trioxide
  • ATO
  • Trisenox
  • 11-040
  • Leukemia
  • Leukemia, Promyelocytic, Acute



Memorial Sloan Kettering Cancer Center New York, New York  10021
Northwestern University Chicago, Illinois  60611
Cleveland Clinic Cleveland, Ohio  44195
University of Southern California Los Angeles, California  90033
New York Presbyterian Hospital-Weill Medical College of Cornell University New York, New York  10065
National Heart, Lung, and Blood Institute (NIH) Bethesda, Maryland  20824