Trial 9L-10-1

A Randomized Phase III Study of Elacytarabine vs. Investigator's Choice in Patients with Late Stage Acute Myeloid Leukemia.

Type: Cancer Therapy
Phase: Phase III
Status: Closed to Accrual with Ongoing Follow-up
Treatments: Chemotherapy: Systemic
Randomized: Yes
Defintions of terms and FAQ about clinical trials.

Trial Leaders/Researchers: Casey O Connell, M.D.
Other Trial Staff: Lori Vergara, R.N., Ibrahim Syed, D.M.

Staff may log in to see study documents.

You may participate in this study if:

	Requirement
1	Confirmed diagnosis of AML according to WHO classification (excluding acute promyelocytic leukemia) who have received two or three previous induction/re-induction regimens. One of the (re-)induction regimens could be stem cell transplantation (SCT) for achievement of remission. Maintenance and consolidation (including SCT) may have been given, but are not counted as previous regimens.
2	BM aspirates and/or biopsies must contain > 5% leukaemic blast cells or patient must have biopsy-proven extramedullary AML, or patient’s peripheral blood shows occurrence of leukemic blast cells
3	Must have: [1] never attained CR or CRi (primary refractory), or [2] failed initial induction therapy, and have attained CR or CRi after salvage therapy(ies), and then relapsed within < 6 months, or [3] attained CR or CRi after initial induction therapy and relapsed within <12 months, and failed to respond to salvage therapy(ies), or [4] relapsed after the latest CR or CRi within < 6 months.
4	At least 18 years of age
5	Patients <65 years should have received previous treatment with cytarabine
6	ECOG performance status 0 – 2
7	Recovered from previous BMT and/or SC transplantation to a stage that the patient can tolerate the study treatment. There is no restriction on number of regimens or type of treatment administered for maintenance or consolidation during previous stages of the disease.
8	Capable of understanding and complying with protocol requirements
9	Signed an approved study-specific informed consent and HIPAA

You may not participate in this study if:

1	History of allergic reactions to egg. History of Gr 3 or 4 allergic reactions to cytarabine.
2	Persistent clinically significant toxicities from previous chemotherapy
3	Cancer history that, according to the investigator, might confound the assessment of the study endpoints
4	Known to be HIV-positive
5	Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements
6	Impairment of hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study
7	Active heart disease including MI within previous 3 months, symptomatic CAD, arrhythmias not controlled by medication, or uncontrolled CHF. Any NYHA Grade 3 or 4.
8	Applicable only for patients for whom an anthracycline is part of the selected control treatment. LVEF must be = / > 45% by MUGA or 2D ECHO within 14 days prior to start of therapy.
9	Applicable only for patients for whom an anthracycline is part of the selected control treatment. Patients with prior treatment with a cumulative dose of daunorubicin or equivalent exceeding 370 mg/m2. The patient should tolerate minimum one course of combination therapy.
10	Receiving any anti-leukemic agent within the last 4 weeks. Hydroxyurea, however, is allowed for up to 12 hours prior to study treatment.
11	Receiving any investigational treatment within the last 14 days
12	Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
13	Pregnant and nursing patients. Women of childbearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to treatment start. Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last elacytarabine dose.

For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.