A Phase I Study of SJG-136 in Patients With Advanced Leukemia
Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trial Reporting Program)
OTHER · M D Anderson Cancer Center
OTHER · CTEP
NIH
interventional
25
1 country
1
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2009
Actual (reported)Study Completion
Not reported
Date not reportedThis 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
March 9, 2006
Actual (reported)March 13, 2006
Actual (reported)February 2009
Actual (reported)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
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.
Given IV
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Farhad Ravandi-Kashani
M.D. Anderson Cancer Center
25 participants (actual enrollment reported by the registry).
First Submitted
March 9, 2006
First Posted
March 13, 2006
Study Start
December 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2009
Actual (reported)Last Updated
September 30, 2013
Record last verified: 2013-09
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Source: ClinicalTrials.gov.
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