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

Sponsor

Seagen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00502112

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

1.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndrome (MDS)	Drug: lintuzumab Drug: lenalidomide	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 lintuzumab and lenalidomide	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 Names: SGN-33 Drug: lenalidomide 10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle Other Names: Revlimid

Arm

Intervention/Treatment

Experimental: 1

lintuzumab and lenalidomide

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 Names:

SGN-33

Drug: lenalidomide

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

Other Names:

Revlimid

Outcome Measures

Primary Outcome Measures

The incidence of adverse events and lab abnormalities [1 month after last dose]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Rocky Mountain Cancer Center	Denver	Colorado	United States	80218
3	Georgetown University	Washington	District of Columbia	United States	20007
4	Georgia Cancer Specialists	Atlanta	Georgia	United States	30342
5	St.Vincent's Comprehensive Cancer Center	New York	New York	United States	10011
6	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
7	Ohio State University	Columbus	Ohio	United States	43210
8	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105