Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

• Status: Terminated
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as clofarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving clofarabine together with daunorubicin may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving clofarabine together with daunorubicin works in treating older patients with newly diagnosed acute myeloid leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Clofarabine; Daunorubicin

Criteria

DISEASE CHARACTERISTICS:

• Newly diagnosed acute myeloid leukemia

• At least 10% blasts in the peripheral blood

• De novo or secondary disease

• No acute promyelocytic leukemia with t[15;17] or any other variant

• No clinical evidence of CNS disease

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST and ALT ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 2.5 times ULN

• LVEF ≥ 45%

• Estimated glomerular filtration rate ≥ 50 mL/min

• Not pregnant or nursing

• Fertile patients must use effective barrier contraception during and for at least 6 months following study treatment

• No known HIV positivity

• Able to comply with study procedures and follow-up examinations

• No psychiatric disorders that would interfere with consent, study participation, or follow-up

• No uncontrolled systemic fungal, bacterial, viral, or other infection (i.e., exhibiting ongoing signs/symptoms related to the infection and without improvement despite appropriate antibiotics or other treatment)

• No history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo induction therapy with both agents

• No other malignancy, unless disease-free for at least 3 years following curative intent therapy

• Nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are allowed if definitive treatment for the condition has been completed

• Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed

• No other severe concurrent disease

PRIOR CONCURRENT THERAPY:

• No other concurrent systemic antileukemic therapy (standard or investigational)

• No concurrent cytotoxic therapy or investigational therapy

• No concurrent alternative medications (e.g., herbal or botanical for anticancer purposes)

• No prior chemotherapy

• Prior hydroxyurea allowed