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Tretinoin and Arsenic Trioxide With or Without Idarubicin in Treating Patients With Acute Promyelocytic Leukemia

This study has been terminated.
(Lack of accrual)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center Identifier:
First received: September 10, 2007
Last updated: December 23, 2015
Last verified: December 2015

RATIONALE: Tretinoin may help cancer cells become more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as arsenic trioxide and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving tretinoin together with arsenic trioxide with or without idarubicin may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving tretinoin together with arsenic trioxide with or without idarubicin works in treating patients with acute promyelocytic leukemia.

Condition Intervention Phase
Drug: arsenic trioxide
Drug: idarubicin
Drug: tretinoin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Combined All-Trans Retinoic Acid and Arsenic Trioxide for Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • Molecular Remission Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    # of patients with Complete Remission

Enrollment: 1
Study Start Date: September 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tretinoin and Arsenic Trioxide With or Without Idarubicin
See Outline for details
Drug: arsenic trioxide Drug: idarubicin Drug: tretinoin

  Show Detailed Description


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Morphologic diagnosis of acute promyelocytic leukemia (APL), confirmed by one of the following:

    • Demonstration of t(15;17) using conventional cytogenetics or fluorescence in situ hybridization (FISH)
    • Positive PML-RARα transcript by reverse transcriptase-polymerase chain reaction (RT-PCR) assay
  • Patients with CNS involvement by APL are eligible


  • Karnofsky performance status 60-100%
  • Creatinine ≤ 2.0 mg/dL or creatinine clearance > 60 mL/min
  • Bilirubin < 2.0 mg/dL (unless attributed to Gilbert disease)
  • Alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 ULN
  • LVEF ≥ 50% on echocardiogram or MUGA scan
  • QTc ≤ 500 msec on baseline ECG
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 4 months after the completion of study treatment
  • No active serious infections not controlled by antibiotics
  • No other concurrent active malignancy requiring immediate therapy
  • No clinically significant cardiac disease (New York Heart Association class III or IV heart disease), including chronic arrhythmias
  • No pulmonary disease
  • No other serious or life-threatening condition deemed unacceptable by the principal investigator


  • No prior treatment for APL
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00528450

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Joseph G. Jurcic, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Peter Maslak, MD Memorial Sloan Kettering Cancer Center
  More Information

Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00528450     History of Changes
Other Study ID Numbers: 07-108  P30CA008748  MSKCC-07108  CEPHALONO-MSKCC-07108 
Study First Received: September 10, 2007
Results First Received: December 23, 2015
Last Updated: December 23, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center:
adult acute promyelocytic leukemia (M3)
adult acute myeloid leukemia with t(15;17)(q22;q12)
untreated adult acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Arsenic trioxide
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Keratolytic Agents
Dermatologic Agents processed this record on October 21, 2016