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

Sponsored by:	Seattle Genetics, Inc.
Information provided by:	Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:	NCT00502112

Purpose

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	Intervention	Phase
Myelodysplastic Syndrome (MDS)	Drug: lintuzumab Drug: lenalidomide	Phase I

Drug Information available for: Lintuzumab Immunoglobulins Globulin, Immune Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase I Combination Trial of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) and Lenalidomide (Revlimid®) in Patients With Myelodysplastic Syndromes (MDS)

Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:

The incidence of adverse events and lab abnormalities [ Time Frame: 1 month after last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	24
Study Start Date:	March 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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 Drug: lenalidomide 10 or 15 mg per day, taken orally on Days 1-14 of each 21-day cycle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502112

Contacts

Contact: Terri Lowe

866-333-7436

clinicaltrials@seagen.com

Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35294
Principal Investigator: James M Foran, MD, FRCP(C)
United States, Colorado
Rocky Mountain Cancer Center	Recruiting
Denver, Colorado, United States, 80218
Principal Investigator: Mark W Brunvand, MD
United States, District of Columbia
Georgetown University	Recruiting
Washington, District of Columbia, United States, 20007
Principal Investigator: Khaled El-Shami, MD
United States, Georgia
Georgia Cancer Specialists	Recruiting
Atlanta, Georgia, United States, 30342
Principal Investigator: Saleh Mansoor, MD
United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10021
Principal Investigator: Joseph Jurcic, MD
United States, Ohio
Ohio State University	Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Rebecca Klisovic, MD
United States, South Dakota
Avera Cancer Institute	Recruiting
Sioux Falls, South Dakota, United States, 57105
Principal Investigator: Vinod Parameswaran, MD

Sponsors and Collaborators

Seattle Genetics, Inc.

Investigators

Study Director:

Eric Sievers, MD

Seattle Genetics, Inc.

More Information

Responsible Party:	Seattle Genetics, Inc. ( Eric Sievers, MD, Sr. Medical Director )
Study ID Numbers:	SG033-0002
Study First Received:	July 13, 2007
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00502112
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:

Lintuzumab
Antigens, CD33
Antibodies, Monoclonal
Combined Modality Therapy

Myelodysplastic Syndromes
Hematologic Diseases
Preleukemia

Study placed in the following topic categories:

Antibodies, Monoclonal
Myelodysplastic syndromes
Antibodies
Preleukemia
Precancerous Conditions
Hematologic Diseases

Myelodysplasia
Myelodysplastic Syndromes
Lenalidomide
Bone Marrow Diseases
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Antineoplastic Agents

Therapeutic Uses
Syndrome
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009