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

NCT00502112 | Completed Phase 1

• 1 other identifier: SG033-0002
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 8

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.

Conditions

Myelodysplastic Syndrome (MDS)

Keywords

Lintuzumab; Antigens, CD33; Antibodies, Monoclonal; Combined Modality Therapy; Myelodysplastic Syndromes; Hematologic Diseases; Preleukemia

Outcome Measures

Primary Outcomes (1)

• The incidence of adverse events and lab abnormalities

  1 month after last dose

Secondary Outcomes (2)

• Antitumor activity

  Every other 21-day cycle

• Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA)

  1 month after last dose

Study Arms (1)

1

EXPERIMENTAL

lintuzumab and lenalidomide

Drug: lintuzumab; Drug: lenalidomide

Interventions

lintuzumab DRUG

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

Also known as: SGN-33

1

lenalidomide DRUG

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

Also known as: Revlimid

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Received prior therapy with lenalidomide, gemtuzumab ozogamicin (Mylotarg®).
• Received chemotherapy/radiotherapy within 4 weeks of study registration.
• Received prior bone marrow transplant.
• q- chromosomal deletion in malignant cells.

Sponsors & Collaborators

• Seagen Inc.: lead

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Georgia Cancer Specialists

Atlanta, Georgia, 30342, United States

Location

St.Vincent's Comprehensive Cancer Center

New York, New York, 10011, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Hematologic Diseases; Preleukemia

Interventions

lintuzumab; Lenalidomide

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hemic and Lymphatic Diseases; Precancerous Conditions; Neoplasms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Eric Sievers, MD

  Seagen Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2007
• First Posted: July 17, 2007
• Study Start: March 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

US (8)