Clinical research and Phase 1 studies have already shown encouraging results which suggests that TPA can be effectively used in the treatment of relapsed/refractory acute myeloid leukemia (AML). However, to confirm these results, further research is needed. Before undergoing these new tests AML patients must understand the investigative nature of the Phase 2 TPA studies in the cure of these terminal diseases. Only patients with a type of AML for which there is no standard therapy, can participate in the study. For full information on all criteria needed to be met and the documents needed to be presented, please contact the study leading medical professional dr. Roger Strair, M.D. PhD, at The Cancer Institute of New Jersey (CINJ).
Both men and women, belonging to all ethnic groups are eligible for this clinical trial. As a general rule, patients enrolling for Phase 2 TPA studies must provide an informed consent to prove that they understand what the clinical trial is about. Before signing the consent form, make sure all your questions regarding the study and the consent form are answered.
Since the effects of TPA on the developing fetus are yet unknown, pregnant women or women who plan on pregnancy cannot participate in the study. For men, since it is not known how TPA affects sperm, it is important to avoid getting a woman pregnant during the study and for a period after that.
There are certain risks and discomforts involved with the TPA treatment. The consent from you will be signing contains a detailed list of these potential risks.
• A histologically documented relapsed/refractory AML for which there is no standard therapy that has been demonstrated to have curative or palliative potential
• ECOG performance status of 0-2
• Age of 18 years or older
• An estimated life expectancy longer than 1 month
• No active infections
• Negative pregnancy test
• No uncontrolled psychiatric illness or medical illness that the principal investigator feels will compromise the patient’s tolerance of the study medication
In addition to meeting the above criteria, laboratory data has to be in between certain limits. Contact the CINJ medical professional for the exact details. Even if all inclusion criteria are met, patients treated with any other investigational drug within the last 30 days prior to entering the study, cannot participate.
Just as is it the case for AML patients, being treated with any other investigational drug within one month prior to entering the study is an exclusion criterion.
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