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

• To define the safety profile of concurrent therapy with SGN-33 and lenalidomide in patients with MDS
• To determine the maximum tolerated dose (MTD) of SGN-33 when administered in combination with lenalidomide.

• Antitumor activity [ Time Frame: Every other 21-day cycle ] [ Designated as safety issue: No ]
• Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA) [ Time Frame: 1 month after last dose ] [ Designated as safety issue: Yes ]

• To obtain preliminary antitumor activity of combination therapy in terms of decreased myeloblasts and hematologic improvement
• To assess the pharmacokinetics (PK), immunogenicity, and cytokine profile of patients treated with SGN-33 and lenalidomide.

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.

• Drug: lintuzumab
  4 or 8 mg/kg IV (in the vein) on Days 1, 8 and 15 for the first 21-day cycle; 4 or 8 mg/kg IV (in the vein) on Days 1 and 8 for the second through the eighth 21-day cycle
  Other Name: SGN-33
• Drug: lenalidomide
  10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle
  Other Name: Revlimid

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.