View Clinical Trial (Medical Research Study)
A Randomized Phase 2 Study of Oral Sapacitabine in Elderly Patients With Acute Myeloid Leukemia Previously Untreated or in First Relapse, or Previously Treated Myelodysplastic Syndromes
| City: |
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Omaha |
| State: |
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Nebraska |
| Zip Code: |
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68198 |
| Conditions: |
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Acute Myeloid Leukemia |
| Purpose: |
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The main objective of this study is to learn which sapacitabine treatment is more likely to
keep the cancer in check for at least one year in AML patients who are at least 70 years of
age or older and in MDS patients who are at least 60 years of age.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- A histologically or pathologically confirmed diagnosis of AML based on WHO
classification which is previously untreated by systemic therapy or is in first
relapse after achieving a complete remission to initial induction, consolidation
and/or maintenance therapy or MDS with IPSS scores of intermediate -2 or higher risk
risk which has been previously treated with hypomethylating agents
- Age 70 years or older for AML and 60 years or older for MDS
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate renal function defined as serum creatinine equal to or less than 1.5 x upper
limit of normal (ULN)
- Adequate liver function defined as total bilirubin or direct bilirubin equal to or
less than 1.5 x ULN; alanine aminotransferase (ALT or SGPT) equal to or less than 2.5
x ULN (5 x ULN if tumor has affected the liver)
- Life expectancy reasonably adequate for evaluating the treatment effect
- Patient must be able to swallow capsules
- Patients must be at least 2 weeks from prior systemic therapy, radiation therapy,
major surgery, or other investigational therapy, and have recovered from clinically
significant toxicities of these prior treatments
- All men and women of reproductive potential must agree to practice effective
contraception for 4 weeks prior to study entry, during the entire study period and
for one month after the study unless documentation of infertility exists
- Ability to understand and willingness to sign the informed consent form
Exclusion Criteria:
- AML is of the sub-type of acute promyelocytic leukemia
- Having received more than one induction systemic therapy for AML or having received a
standard dose or high dose ara-C containing regimen for MDS
- Patients with known central nervous system (CNS) involvement by leukemia
- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, active cancer(s) other than AML, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements. Patients receiving
intravenous antibiotics for infections that are under control may be included in this
study
- Known to be HIV-positive
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| NCT ID: |
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NCT00590187 |
| Primary Contact: |
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Study Director
Judy H. Chiao, M.D.
Cyclacel Pharmaceuticals, Inc.
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| Backup Contact: |
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N/A |
| Location Contact: |
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Omaha, Nebraska 68198
United States
Rose Solberg, RN
Phone: 402-559-4810
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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