CLINICAL TRIAL SUMMARY

MDACC Study No:2009-0772 (clinicaltrials.gov NCT No: NCT01037556)
Title:Phase I/II Study of PR104 in Subjects with Refractory/Relapsed Acute Leukemia using Adaptive Dose Selection
Principal Investigator:Marina Konopleva
Treatment Agent:PR104
Study Status:Terminated
Study Description:The goal of this clinical research study is to find the highest tolerable dose
of PR104 that can be given to patients with AML. After the highest tolerable
dose is found, additional patients with AML or ALL will be enrolled in this
study. Another goal of this clinical research study is to learn if PR104 can
help to control AML and ALL. The safety of the study drug will also be
studied.

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Disease Group:Hematologic Disorder; Leukemia
Phase of Study:Phase I/Phase II
Treatment Agents:PR104
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:PR104 will be administered primarily on an outpatient basis. PR104 may be
administered as an inpatient based at the discretion of the treating
physician.The length of hospital stay is 1-2 days every 2-3 weeks during 3
cycles of induction.
Supported By:Proacta Inc.
Return Visit:1-3 times weekly during induction courses (1-3), then weekly during
consolidation courses (1-4) if administered at MDACC. If during the
consolidation courses the patients are followed by the local oncologist, they
must come to MDACC every 3 weeks.
Home Care:Supportive care only.


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Physician Name:Marina Konopleva
Dept:Leukemia
For Clinical Trial Enrollment:713-794-1628
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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