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Combination Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center Identifier:
First received: January 12, 2006
Last updated: April 16, 2014
Last verified: April 2014

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy works in treating patients with acute promyelocytic leukemia.

Condition Intervention Phase
Drug: arsenic trioxide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: mercaptopurine
Drug: methotrexate
Drug: tretinoin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Pilot Study of Arsenic Trioxide-Based Consolidation Therapy for the Primary Treatment of Acute Promyelocytic Leukemia

Resource links provided by NLM:

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Disease-free survival at 2 and 5 years after study completion
  • Safety of arsenic trioxide following cytarabine and anthracycline immediately after study completion

Secondary Outcome Measures:
  • Validate peripheral blood real-time PCR for minimal disease monitoring as measured by real-time PCR for PML-RARalpha monthly for two years after study completion

Study Start Date: October 2004
Study Completion Date: June 2013
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine, preliminarily, the safety of incorporating arsenic trioxide (ATO) into cytarabine and daunorubicin hydrochloride-based consolidation therapy followed by tretinoin maintenance therapy in patients receiving induction tretinoin and daunorubicin hydrochloride with acute promyelocytic leukemia (APL) induced into remission with tretinoin and daunorubicin hydrochloride.
  • Determine, preliminarily, the efficacy of this strategy in inducing and maintaining molecular remissions in patients treated with this regimen.

OUTLINE: This is a pilot, multicenter study.

  • Induction therapy: Patients receive oral tretinoin twice daily on days 1-60 and daunorubicin hydrochloride IV on days 4, 6, and 8. Patients are evaluated between days 60-67 and proceed to consolidation therapy.
  • Consolidation therapy: Patients receive cytarabine IV continuously on days 1-3, daunorubicin hydrochloride IV on days 1-3, and arsenic trioxide IV over 1-2 hours once daily, 5 days a week, beginning on day 8 and continuing for 6 weeks. Patients with clinical and/or cytogenic, but not molecular, remission receive additional arsenic trioxide once daily, 5 days a week, for 30 doses (6 weeks). Patients achieving clinical and molecular remission after completion of 6 or 12 weeks of arsenic trioxide proceed to maintenance therapy.
  • Maintenance therapy: Patients receive oral tretinoin once daily on days 1-15. Treatment repeats every 3 months for 8 courses (2 years).

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.


Ages Eligible for Study:   5 Years to 74 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of acute promyelocytic leukemia (APL) by morphologic and flow cytometric documentation (high orthogonal light scatter, lack of HLA-DR expression)

    • Patients with classical APL as well as the microgranular variant (M3V) are eligible

      • In cases where the diagnosis is unclear, consultation with a hematopathologist is required before enrolling the patient in the study
  • Patients found to have cytogenetic abnormalities that do not produce the PML-RARα gene rearrangement will be removed from study and will not be included in data analysis


  • Patients will not be excluded because of performance status or comorbid disease
  • Premenopausal female patients must have a negative pregnancy test


  • No prior chemotherapy for APL except hydroxyurea
  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: NCT00276601

United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
United States, Georgia
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Steven D. Gore, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Responsible Party: Steven D. Gore, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT00276601     History of Changes
Other Study ID Numbers: J0442, CDR0000449985
P30CA006973 ( US NIH Grant/Contract Award Number )
Study First Received: January 12, 2006
Last Updated: April 16, 2014

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
untreated adult acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
adult acute promyelocytic leukemia (M3)
childhood acute promyelocytic leukemia (M3)
adult acute myeloid leukemia with t(15;17)(q22;q12)

Additional relevant MeSH terms:
Leukemia, Promyelocytic, Acute
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Arsenic trioxide
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antiviral Agents
Anti-Infective Agents
Antibiotics, Antineoplastic processed this record on April 26, 2017