Trial Information

Summary: A Phase I-II Pilot Study of Divalproex Sodium and All-Trans-Retinoic Acid (ATRA) in Relapsed or Refractory Acute Myeloid Leukemia (except M3, FAB Classification)

The purpose of this research study is to: 1) determine the safety of divalproex sodium alone and in combination with ATRA in the treatment of Acute Myeloid Leukemias (AML); 2) gain an insight into the way in which these drugs may be beneficial in the treatment of leukemia; and 3) evaluate the biological effects of these drugs in leukemic cells.
No Compensation Provided

Patient Inclusion/Exclusion Criteria:

1. Patients with acute myeloid leukemia, which has not responded to initial treatment or which has recurred after a previous response to treatment.
2. Patients with myelodisplastic syndrome (a pre-leukemic condition that predisposes to leukemia) that progressed to acute myeloid leukemia.
3. Patients over the age of 60 who choose not to undergo standard chemotherapy.

1. Known central nervous system disease(leukemia in the brain and spine.
2. Patients with severe liver problems.
3. Patients who have a donor and are able or willing to undergo Bone Marrow Transplant (BMT).
4. Patients who relapsed after 12 months and are able or willing to undergo chemotherapy followed by BMT.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.