CLINICAL TRIAL SUMMARY

MDACC Study No:2003-0578 (clinicaltrials.gov NCT No: NCT01159028)
Title:A Phase I Clinical Trial to Study the Safety, Pharmacokinetics, and Efficacy of BP-100-1.01 (L-Grb-2 Antisense Oligonucleotide) in Patients with Refractory or Relapsed Acute Myeloid Leukemia, Philadelphia Chromosome Positive Chronic Myelogenous Leukemia, or Acute Lymphoblastic Leukemia, and Myelodysplastic Syndrome
Principal Investigator:Jorge Cortes
Treatment Agent:L-Grb-2 Antisense Oligonucleotide
Study Status:Open
Study Description:The goal of this clinical research study is to find the highest safe dose of a
liposomal Growth Factor Receptor Bound Protein-2 antisense oligodeoxynucleotide
(L-Grb2 AS) that can be given as treatment for patients with Philadelphia
Chromosome positive CML and other disease conditions described earlier. The
trade name of this drug is BP-100-1.01. The response of the leukemia to this
treatment will also be studied. In addition, the time needed for the body to
process this drug will be evaluated.

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Disease Group:Leukemia
Phase of Study:Phase I
Treatment Agents:L-Grb-2 Antisense Oligonucleotide
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:No hospitalizations are expected.
Supported By:N/A
Return Visit:Patients must return to clinic twice weekly.
Home Care:All treatment will be administered at M.D. Anderson Cancer Center in the
Clinical and Translational Research Center.


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Physician Name:Jorge Cortes
Dept:Leukemia
For Clinical Trial Enrollment:713-794-5783
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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