Sponsor study identifier
interventional
28
1 country
1
Study Start
May 1999
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2013
Actual (reported)Study Completion
February 2013
Actual (reported)The goal of this clinical research study is to find the highest safe dose of the anti-CD33 immunotoxin HuM-195/rGel that can be given to patients with advanced myeloid malignancies. This treatment will be given to patients whose leukemia has not responded to prior chemotherapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2013
Actual (reported)Click on a node to explore related trials.
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.
May 1999
Date type not reportedThis date has not been verified as actual or estimated.
May 24, 2002
Actual (reported)May 27, 2002
Actual (reported)February 2013
Actual (reported)February 2013
Actual (reported)Maximum Tolerated Dose (MTD)
Dose-limiting toxicity considered to have occurred when (1) \>grade 2 extramedullary toxicity possibly related to HuM195/rGel (except nausea, vomiting or diarrhea unless uncontrolled by optimal management, or electrolyte abnormalities unless clinically significant or not correctable after optimal replacement) is observed or (2) \>42 days from day 1 of therapy elapse before return of neutrophil count to \>500 and platelet count to \>25,000 in absence of leukemia (i.e., with a normal or hypercellular bone marrow with \<5% blasts).
Continuous assessment of safety throughout entire study period and determination of dose-limiting toxicities at end of two week evaluation period (4 weeks from start of therapy).
HuM195/rGel starting Dose = 3 mg/m\^2 twice weekly for 2 weeks.
Starting Dose = 3 mg/m\^2 twice weekly for 2 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Jorge Cortes, MD
M.D. Anderson Cancer Center
28 participants (actual enrollment reported by the registry).
First Submitted
May 24, 2002
First Posted
May 27, 2002
Study Start
May 1999
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2013
Actual (reported)Study Completion
February 2013
Actual (reported)Last Updated
April 4, 2013
Record last verified: 2013-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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