CLINICAL TRIAL SUMMARY

MDACC Study No:2007-0727 (clinicaltrials.gov NCT No: NCT00590187)
Title:A Randomized Phase II Study of Oral Sapacitabine in Elderly Patients with Acute Myeloid Leukemia Previously Untreated or in First Relapse, or Previously Treated Myelodysplastic Syndrome
Principal Investigator:Hagop Kantarjian
Treatment Agent:Sapacitabine
Study Status:Open
Study Description:The goal of the first part of this clinical research study is to look at how
well 3 different doses of sapacitabine can help to control AML in patients who
are least 70 years of age or MDS in patients who are at least 60 years of age.
The safety and tolerability of sapacitabine will also be studied.

The main goal of the second part of the study is to learn if sapacitabine can
improve blood cell counts and lower the amount of leukemia in bone marrow.

The main goal of the third, fourth, and fifth part of this study is to learn
which of the 3 doses of sapacitabine can help to control the disease for at
least one year in patients who are least 70 years of age or older with AML or
60 years of age or older with MDS. Parts 1, 2, 3, and 4 of this study have
been completed.

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Disease Group:Leukemia
Phase of Study:Phase II
Treatment Agents:Sapacitabine
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:NA
Supported By:Cyclacel Ltd.
Return Visit:Cycle 1, Days 1, 8 and 15
Cycle 2 and subsequent cycles, Day 1

Follow-up visit: 28 days after last dose.

(All days + 3 days)
Home Care:Self-medicated


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Physician Name:Hagop Kantarjian
Dept:Leukemia
For Clinical Trial Enrollment:713-792-7026
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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