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Combination Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00276601
First received: January 12, 2006
Last updated: April 16, 2014
Last verified: April 2014

January 12, 2006
April 16, 2014
October 2004
December 2007   (final data collection date for primary outcome measure)
  • Disease-free survival at 2 and 5 years after study completion [ Designated as safety issue: No ]
  • Safety of arsenic trioxide following cytarabine and anthracycline immediately after study completion [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00276601 on ClinicalTrials.gov Archive Site
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 [ Designated as safety issue: No ]
Not Provided
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Combination Chemotherapy in Treating Patients With Acute Promyelocytic Leukemia
A Pilot Study of Arsenic Trioxide-Based Consolidation Therapy for the Primary Treatment of Acute Promyelocytic Leukemia

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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Primary Purpose: Treatment
Leukemia
  • Drug: arsenic trioxide
  • Drug: cytarabine
  • Drug: daunorubicin hydrochloride
  • Drug: mercaptopurine
  • Drug: methotrexate
  • Drug: tretinoin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
June 2013
December 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for APL except hydroxyurea
Both
5 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00276601
J0442, CDR0000449985, P30CA006973, JHOC-J0442, WIRB-20041058
Not Provided
Steven D. Gore, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Steven D. Gore, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP