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Completed

NCT Number: NCT00502112

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

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.

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Key information

Conditions

Myelodysplastic Syndrome (MDS) Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes Neoplasms Precancerous Conditions Preleukemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: SGN-33

Lenalidomide

Drug

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

Other names: Revlimid

Primary outcomes

  1. The incidence of adverse events and lab abnormalities

    Time frame: 1 month after last dose

Secondary outcomes

  1. Antitumor activity

    Time frame: Every other 21-day cycle

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

    Time frame: 1 month after last dose

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 17, 2007
Registry last updated
Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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