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A Pilot Study of Arsenic Trioxide-Based Consolidation Therapy for the Primary Treatment of Acute Promyelocytic Leukemia


Phase 2
5 Years
74 Years
Open (Enrolling)
Both
Leukemia

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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 HopkinsBaltimore, Maryland  21231-2410
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
Blood and Marrow Transplant Group of GeorgiaAtlanta, Georgia  30342-1601