A Phase I Study of Lintuzumab Combined With Lenalidomide in Patients With Myelodysplastic Syndromes (MDS)

Completed · Phase 1

Conditions studied: Myelodysplastic Syndrome (MDS)

In brief

This study is a phase I, open-label, single-arm, dose escalation trial to determine the safety and activity of lenalidomide combined with lintuzumab in patients with MDS. Small groups of 3-6 patients will be treated with pre-specified doses of lenalidomide and lintuzumab and will receive 3-week cycles of combination therapy.

Key facts

Study ID

NCT00502112

Run by

Seagen Inc.

People needed

13

Starts

2008-03-01

Expected to finish

2010-05-01

Last updated by the study team

2011-10-12

Who can join

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

You may qualify if…

• Disease confirmation of MDS.
• Between 5% and 30% blasts in the bone marrow.
• Received treatment for cytopenias within 2-months
• ECOG ≤ 2.

You may not qualify if…

• Received prior therapy with lenalidomide, gemtuzumab ozogamicin (Mylotarg®).
• Received chemotherapy/radiotherapy within 4 weeks of study registration.
• Received prior bone marrow transplant.
• 5q- chromosomal deletion in malignant cells.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Georgia Cancer Specialists — Atlanta, Georgia, United States
• St.Vincent's Comprehensive Cancer Center — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Ohio State University — Columbus, Ohio, United States
• Avera Cancer Institute — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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