Leukemia

The purpose of this research study is to determine the safety and efficacy of an experimental treatment for patients with acute myeloid leukemia.

Participants in this study will receive an infusion of cord-blood progenitor cells after receiving a course of chemotherapy that includes the drugs clofarabine and cytarabine. Patients will also receive granulocyte-colony stimulating factor. The cord-blood infusion may be followed by up to 3 more courses of chemotherapy.

Hematopoietic progenitor cells are cells that give rise to the blood system. The cord-blood progenitor cells will be grown or "expanded" in a laboratory before the infusion takes place. The cord-blood progenitor cells will not be genetically matched with the participant?s tissue type. This study is being done to determine whether or not giving these expanded cells after chemotherapy is safe and helps the blood system to recover more quickly from chemotherapy.

Cytarabine is approved by the Food and Drug Administration (FDA) for use in AML. Clofarabine is approved for use in some pediatric patients with another type of leukemia, called acute lymphoblastic leukemia (ALL).

Participants will receive treatment at the Seattle Cancer Care Alliance (SCCA) and University of Washington Medical Center (UWMC).

The study includes up to 6 months of study treatment for participants who receive all 4 courses of chemotherapy. After that, we would like to maintain follow-up contact for a total of 5 years on study.

• 18-70 years of age
• Diagnosed with one of the following:
  • Acute myeloid leukemia (by WHO criteria), either relapsed or refractory
  • Untreated AML patients with cytogenetic or molecular abnormalities associated with poor prognosis
  • Untreated AML patients with intermediate prognosis

Other eligibility criteria may apply.

• Allogeneic transplant recipients
• Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
• Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver (including symptomatic hepatitis, veno-occlusive disease), or other organ system dysfunction
• Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
• Pregnant or lactating patients
• Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results

Other exclusion criteria may apply.