A Phase I Study of SJG-136 in Patients With Advanced Leukemia
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.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
21 days
Yes
Farhad Ravandi-Kashani
Principal Investigator
M.D. Anderson Cancer Center
United States: Food and Drug Administration
NCI-2009-00100
NCT00301769
December 2005
Name | Location |
---|---|
M D Anderson Cancer Center | Houston, Texas 77030 |