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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01019317 |
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Date of registration:
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23/11/2009 |
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Primary sponsor: |
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Public title:
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Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
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Scientific title:
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A Phase II Study of Twice Daily Cytarabine and Fludarabine in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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151 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01019317 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Elias Jabbour, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UT MD Anderson Cancer Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Sign an IRB-approved informed consent document.
2. Age >/= 12 years.
3. Diagnosis of AML [other than acute promyelocytic leukemia (APL)] with
refractory/relapsed disease. Patients with newly diagnosed AML will be eligible if
not a candidate for intensive chemotherapy. Patients with high-risk (intermediate-2
or high by IPSS or >/=10% blasts) MDS will also be eligible. Patients with chronic
myeloid leukemia (CML) in blast crisis will be eligible as well.
4. ECOG performance status of
5. Organ function as defined below (unless due to leukemia): i. Serum creatinine mg/dL; ii. Total bilirubin if related to disease.
6. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy
test within 7 days . Men must agree not to father a child and agree to use a condom
if his partner is of child bearing potential.
Exclusion Criteria:
1. Pregnant or breastfeeding females.
2. Diagnosis of acute promyelocytic leukemia (M3).
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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AML
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CML
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Leukemia
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MDS
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Intervention(s)
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Drug: Cytarabine
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Drug: Fludarabine
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Primary Outcome(s)
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Patients Response Rate
[Time Frame: Following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7). Cycle is 4-6 weeks.]
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Secondary ID(s)
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2009-0781
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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