Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia

Cephalon

Status and phase: Terminated; Phase 3

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Arsenic trioxide; Drug: Low-dose cytarabine alone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00513305

C18477/3059/AM/US-CA

Details and patient eligibility

About

The primary objective of this study is to determine whether low-dose cytarabine in combination with arsenic trioxide is more effective than low-dose cytarabine alone in achieving complete remission in elderly patients (≥60 years of age) with acute myeloid leukemia.

Enrollment: 67 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient has confirmed acute myeloid leukemia (AML).
• The patient is unwilling or unable to tolerate conventional induction chemotherapy.
• The patient has no comorbid conditions that would limit life expectancy to less than 3 months.
• Patient must meet specific laboratory parameters for study inclusion.

Exclusion criteria

• The patient has had previous cytotoxic chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Previous treatment with low-dose cytarabine is not permitted.

• The patient has a QT interval outside of the protocol-specified range.
• The patient has laboratory values outside of protocol-specified ranges.
• The patient is concurrently treated with cytotoxic therapy, radiation, or investigational agents.
• The patient has uncontrolled, severe cardiovascular or pulmonary disease or other uncontrolled medical condition.
• The patient has known central nervous system involvement with AML.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

Low-dose cytarabine plus arsenic trioxide

Active Comparator group

Description:

Cycle 1 cytarabine 10 mg/m\^2 was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2 A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m\^2 sc bid on days 1 through 7 of a 28-day cycle.

Treatment:

Drug: Arsenic trioxide

Drug: Low-dose cytarabine alone

Low-dose cytarabine alone

Active Comparator group

Description:

Cytarabine was administered at a dose of 10 mg/m\^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine was given to patients with persistent disease. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. Recovery period up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m\^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.

Treatment:

Drug: Low-dose cytarabine alone