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University of Florida Shands Cancer Center


Faculty Contacts

Randy Brown, MD
(352)273-5100
Christopher R. Cogle, MD
(352) 273-7493
Nam Dang, MD, PhD
(352) 273-9168
John Hiemenz, MD
(352) 273-9168
Jack Hsu, MD
(352) 273-7823
James Lynch, MD
(352) 273-9168
Merry-Jennifer Markham, MD
(352) 273-8699
Stratford May, MD, PhD
(352) 273-7760
Jan Moreb, MD
(352) 273-7823
Maxim Norkin, MD, PhD
(352) 273-5100
John Wingard, MD
(352) 273-7760
Mona Wirk
(352) 273-5100


Useful Links

UF Department of Medicine Division of Hematology and Oncology
Shands at UF
UF Shands Cancer Center
UF&Shands Clinical Trials




Acute Myeloid Leukemia and MDS Update

This newsletter reports on new therapies for acute myeloid leukemia (AML) and the myelodysplastic syndromes (MDS) at the University of Florida Shands Cancer Center.

If you would like additional information about any of these trials, please contact the trial's principal investigator listed with each trial description. To refer a patient for one of these trials, contact the UF&Shands Hematologic Malignancies and BMT Program patient coordinator, Atha Ellerker, at (352) 265-0111, ext. 2-9452.



In This Issue:

Phase I Study of Oral Vidaza in Newly Diagnosed LOW & INT-1 MDS
Phase I Study of OXi4503 in Relapsed and Refractory AML and MDS
Transplant For MDS Patients on Medicare
Phase II Study of Lenalidomide + Prednisone in LOW & INT-1, Non-Del5q MDS
A Phase III Study of Elacytarabine in Relapsed and Refractory AML




Phase I Study of Oral Vidaza in Newly Diagnosed LOW & INT-1 MDS

Azacitidine (Vidaza) offers improved outcomes in patients with MDS. Research indicates that exposure to prolonged and low doses of Vidaza may result in better responses. Moreover, an oral formulation would maximize convenience to the patient. Thus, oral Vidaza is being tested in 14-day and 21-day schedules. Preliminary data from the trial show safety, feasibility and early evidence of improved responses (ASH 2010). Eligible patients include those with low and intermediate-1 IPSS risk MDS and cytopenias. Study PI: Chris Cogle, MD


Phase I Study of OXi4503 in Relapsed and Refractory AML and MDS

Despite initial remissions with 7+3 induction chemotherapy, the 5 year overall survival for patients with AML is approximately 20%, largely due to relapsed disease. New strategies are needed to eradicate minimal residual disease. Emerging evidence shows that the bone marrow microenvironment protects and promotes leukemia cells. Researchers at the University of Florida Shands Cancer Center have recently developed a novel drug, OXi4503, which shows the dual potential of (1) destroying the blood vessels supporting leukemia cells and (2) directly killing the malignant myeloblasts through generation of intracellular reactive oxygen species (Madlambayan et al, Blood 2010). The researchers have now translated this discovery into a phase I clinical trial of OXi4503 in patients with relapsed and refractory AML and MDS (ClinicalTrials.Gov Identifier NCT01085656). Study PI: Chris Cogle, MD


Transplant For MDS Patients on Medicare

Allogeneic hematopoietic cell transplant is the only curative treatment option for patients with MDS; however, the procedure can be risky and traditionally Medicare has not covered transplant for MDS patients. In response to new data that show improved transplant outcomes in older individuals, the Centers for Medicare & Medicaid Services (CMS) decided to cover transplant for patients with MDS only for beneficiaries who are enrolled in an approved clinical study. An approved study is now open at the University of Florida and Shands Cancer Hospital at UF. Eligibility includes Medicare beneficiaries of any age and with a diagnosis of MDS or CMML. Study PI: John R. Wingard, MD


Phase II Study of Lenalidomide + Prednisone in LOW & INT-1, Non-Del5q MDS

Lenalidomide (Revlimid) brings about improved outcomes in patients with MDS, particularly those with deletion of the long arm of chromosome 5. Several mechanisms of action have been studied. In particular, lenalidomide is believed to increase hematopoietic stem and progenitor cell sensitivity to erythropoietin. Early clinical trials of lenalidomide alone in patients with non-del5q MDS showed 26% of patients achieving transfusion independence. In an effort to improve erythroid response, prednisone is now being added given evidence that this corticosteroid further potentiates the erythropoietin effect. In this phase II study, eligible patients must have low or intermediate-1 IPSS risk, or CMML and require transfusions. This study is in collaboration with Moffitt Cancer Center. Study PI: Chris Cogle, MD


A Phase III Study of Elacytarabine in Relapsed and Refractory AML

Refractory and relapsed AML carries a grim prognosis. One mechanism of leukemia resistance is lack of transport proteins to carry cytotoxic drugs across the leukemia cell membrane and into the cytoplasm. Thus a lipid formulation of cytarabine has been developed to bypass the need for active transport molecules. Instead, this lipid-conjugated agent passively flows into the leukemia cell and greater intracellular concentrations can be achieved. In early phase clinical trials, survival times were three times longer in patients receiving elacytarabine than historical controls. A phase III registration trial is now being conducted to compare elacytarabine against conventional care regimens in patients with relapsed and refractory AML. Study PI: Jack Hsu, MD


UF Shands Cancer Center
Acute Myeloid Leukemia and MDS Update
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