A Pilot Study of Arsenic Trioxide-Based Consolidation Therapy for the Primary Treatment of Acute Promyelocytic Leukemia
5 Years
74 Years
Both
Leukemia
Trial Information
A Pilot Study of Arsenic Trioxide-Based Consolidation Therapy for the Primary Treatment of 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.
Inclusion Criteria
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-RARĪ±
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Disease-free survival at 2 and 5 years after study completion
Safety Issue:
No
Principal Investigator
Steven D. Gore, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
J0442, CDR0000449985
NCT ID:
NCT00276601
Start Date:
October 2004
Completion Date:
Related Keywords:
- Leukemia
- 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)
- Leukemia
- Leukemia, Promyelocytic, Acute
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
| Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama 35294 |
| University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
| Blood and Marrow Transplant Group of Georgia | Atlanta, Georgia 30342-1601 |
