Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if the combination of clofarabine, cytarabine, and idarubicin can help to control Acute Myeloid Leukemia (AML) in patients who are between the ages of 18 and 60 years old. The safety of this study drug combination will also be studied.

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

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Clofarabine; Cytarabine; Idarubicin

Criteria

Inclusion Criteria:

1. Diagnosis of AML (World Health Organization (WHO) classification)

2. Patients must be chemotherapy-naïve, i.e. not have received any prior cytotoxic chemotherapy for AML (with the exception of hydroxyurea). They could have received prior therapy with hypomethylating agents, targeted, or biological agents.

3. Age 18 to 60 years.

4. Eastern Cooperative Oncology Group (ECOG) performance status

5. Serum creatinine1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 mL/min/1.73m^2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73m^2)=186 * (serum creatinine)^-1.154 x (age in years)^-0.023 * (0.742 if patient is female) * (1.212 if patient is black), where SCr is serum creatinine measured in mg/dL. serum bilirubinincrease is due to hemolysis or a congenital disorder); serum transaminases (SGPT and/or SGOT)

6. Cardiac ejection fraction >/= 45% (by either echocardiography or MUGA scan).

7. Ability to understand and provide signed informed consent.

Exclusion Criteria:

1. Patients with acute promyelocytic leukemia (APL).

2. Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.

3. Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or condoms by their partner) over the entire course of therapy.

4. Active and uncontrolled infection requiring therapy with IV antibiotics or antifungal therapy. Prior or concurrent history of one or more opportunistic infections (e.g., cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB).