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

Myelodysplastic Syndrome (MDS) Clinical Trial

Official title:

A Phase I Combination Trial of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) and Lenalidomide (Revlimid®) in Patients With Myelodysplastic Syndromes (MDS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502112
• Other study ID #: SG033-0002
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2007
• Last updated: October 7, 2011
• Start date: March 2008
• Est. completion date: May 2010

Study information

• Verified date: October 2011
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndrome (MDS)
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

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
• lenalidomide
10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse events and lab abnormalities		1 month after last dose	Yes
Secondary	Antitumor activity		Every other 21-day cycle	No
Secondary	Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA)		1 month after last dose	Yes