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

Phase 1

Completed

• Conditions: Myelodysplastic Syndrome (MDS)
• Interventions: Drug: lintuzumab; Drug: lenalidomide

• Registration Number: NCT00502112
• Lead Sponsor: Seagen Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-13
• Study First Submitted QC: 2007-07-16
• Study First Posted: 2007-07-17
• Study Start: 2008-03
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-07
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	lintuzumab	lintuzumab and lenalidomide
1	lenalidomide	lintuzumab and lenalidomide

Primary Outcome Measures

Name	Time	Method
The incidence of adverse events and lab abnormalities	1 month after last dose

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA)	1 month after last dose
Antitumor activity	Every other 21-day cycle

Trial Locations

Locations (8)

Georgetown University; 🇺🇸 Washington, District of Columbia, 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

Avera Cancer Institute; 🇺🇸 Sioux Falls, South Dakota, United States

Rocky Mountain Cancer Center; 🇺🇸 Denver, Colorado, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Georgia Cancer Specialists; 🇺🇸 Atlanta, Georgia, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States