Leukemia Clinical Trial
Official title:
Phase II Study of Perifosine in Patients With Refractory and Relapsed Leukemia
This is a Phase II trial designed to determine the efficacy and safety of perifosine in patients with leukemia who develop progressive disease or recurrence while receiving therapy.
This is a Phase II study of perifosine in patients with refractory and relapsed leukemia.
After a one time loading dose of 600 mg (150 mg x 4 at least 4 hours apart) during the first
cycle, perifosine will be given orally at 100 mg once a day continuously. Cycles are 28 days
in length. Intra-patient dose escalation for the maintenance dose to 150 mg daily will be
done in the second cycle if no non-hematological toxicities beyond grade 0-1 occurred during
the first cycle are observed.
Patients will be assessed for efficacy at the end of each 28 day cycle of therapy, +/- 7
days. Complete remissions, partial remissions and hematological improvements of any kind will
be counted towards an objective response for all diseases.
A maximum total of 74 patients will be enrolled on the study, all of them assigned to the
same experimental treatment scheme (arm) described above.
A maximum total of 37 evaluable patients will be entered in each of two diagnostic groups,
which are being distinguished due to different anticipated rates of accrual. Group 1: AML,
MDS, CML-BP non-lymphoid, CMML, Agnogenic Myeloid Metaplasia (AMM); Group 2: CLL, ALL, CML-BP
lymphoid.
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