Azacitidine and Lintuzumab in Treating Patients With Previously Untreated Myelodysplastic Syndromes

Stopped early · Phase 2

Conditions studied: Leukemia, Myelodysplastic Syndromes

In brief

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as lintuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with monoclonal antibodies may be a better way to block cancer growth. PURPOSE: This phase II trial is studying the side effects and how well giving azacitidine together with lintuzumab works in treating patients with previously untreated myelodysplastic syndromes.

Key facts

Study ID

NCT00997243

Run by

Alison Walker

People needed

7

Starts

2009-11-01

Expected to finish

2011-05-01

Last updated by the study team

2017-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients who have had chemotherapy or radiotherapy within 6 months (for other cancers) prior to entering the study.
• Patients receiving any other investigational agents or patients that have received other investigational agents within 1 month of enrollment.
• Patients with active central nervous system disease or with granulocytic sarcoma as sole site of disease.
• Patients with history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZA or lintuzumab that are not easily managed are excluded. Patients with hypersensitivity to mannitol are excluded.
• Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. As infection is a common feature of MDS, patients with active infection are permitted to enroll provided that the infection is under control. Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
• Psychiatric conditions that prevent compliance with protocol or consent.
• Pregnant women or women who are breastfeeding are excluded from this study.
• HIV-positive patients on combination antiretroviral therapy are ineligible.
• Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Patients with baseline fibrinogen <100mg/dL, or those with clinically significant disseminated intravascular coagulation, are excluded.
• Patients who require ongoing therapeutic anticoagulation with warfarin, lovenox, or similar agent are excluded. This does not apply to patients on low dose prophylaxis therapy.
• Patients who require ongoing clopidogrel therapy are excluded. In cases where clopidogrel use at screening is subsequently discontinued due to ongoing or future risk of drug and treatment related cytopenias, such patients will be eligible.
• Patients with platelet <10,000/uL who are refractory to platelet transfusion are not eligible (must bump to at least >10,000/uL after transfusion)
• Patients who have previously received lenalidomide or thalidomide are excluded.

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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