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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Treatments: Antibodies, Monoclonal; Lenalidomide; Lintuzumab; Thalidomide

Criteria

Inclusion Criteria:

1. Disease confirmation of MDS.

2. Between 5% and 30% blasts in the bone marrow.

3. Received treatment for cytopenias within 2-months

4. ECOG ≤ 2.

Exclusion Criteria:

1. Received prior therapy with lenalidomide, gemtuzumab ozogamicin (Mylotarg®).

2. Received chemotherapy/radiotherapy within 4 weeks of study registration.

3. Received prior bone marrow transplant.

4. 5q- chromosomal deletion in malignant cells.