Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase I Study of SJG-136 in Patients With Advanced Leukemia
This phase I trial is studying the side effects and best dose of SJG-136 in treating patients with relapsed or refractory acute leukemia, myelodysplastic syndromes, blastic phase chronic myelogenous leukemia, or chronic lymphocytic leukemia. Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
OBJECTIVES:
I. Establish the maximum tolerated dose of SJG-136 in patients with relapsed or refractory
acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) myelodysplastic syndrome
(MDS), chronic myelogenous leukemia in blastic phase (CML-BP), or chronic lymphocytic
leukemia (CLL).
II. Determine dose-limiting toxicities and pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive SJG-136 IV over 15 minutes on days 1-5. Courses repeat every 21 days in the
absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of SJG-136 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity. A total of 10 patients are treated at the MTD.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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