NCT00283114

Brief Summary

Phase 1a is an open-label, multi-dose, single-arm, dose-escalation study to define the toxicity profile, pharmacokinetics, and antitumor activity of SGN-33 in patients with myelodysplastic syndrome (MDS), acute myelogenous leukemia(AML), and CD33+ myeloproliferative diseases. Phase 1b includes patients with AML or MDS treated at the highest tolerated dose from phase 1a.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_1

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

4.2 years

First QC Date

January 25, 2006

Last Update Submit

December 17, 2014

Conditions

Acute Myeloid LeukemiaMyelodysplastic SyndromeMyeloproliferative DisordersChronic Myelomonocytic Leukemia

Keywords

LintuzumabAntigens, CD33Antibodies, MonoclonalLeukemia, Myeloid, AcuteMyelodysplastic SyndromesHematologic DiseasesMyeloproliferative DisordersLeukemia

Outcome Measures

Primary Outcomes (3)

  • The incidence of adverse events and lab abnormalities.

    13 months

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

    13 months

  • Antitumor activity.

    13 months

Study Arms (1)

1

EXPERIMENTAL
Drug: lintuzumab

Interventions

lintuzumabDRUG

1.5 - 8 mg/kg IV (in the vein) on Days 1, 8, 15, 22 and 29 of Cycle 1; 1.5 - 8 mg/kg IV (in the vein) every other week for all subsequent cycles

Also known as: SGN-33
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have a diagnosis of MDS or AML.
  • Patients must have an ECOG performance status ≤ 2 and a life expectancy \> 3 months.

You may not qualify if:

  • Patients who have received prior therapy with gemtuzumab ozogamicin (Mylotarg®) or other anti-CD33 monoclonal antibody treatment.
  • Patients with a prior allogeneic transplant.
  • Patients with known leptomeningeal or CNS involvement of leukemia. Patients with onset of CNS symptoms within the past 12 months will also be excluded.
  • Patients receiving chemotherapy within the last four weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Cancer Care Specialists of Central Illinois

Decatur, Illinois, 62526, United States

Location

Indiana Oncology-Hematology Consultants

Indianapolis, Indiana, 46107, United States

Location

University of Massachusetts Medical Center

Worcester, Massachusetts, 01605, 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

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Cancer Center of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Related Publications (1)

  • Raza A, Jurcic JG, Roboz GJ, Maris M, Stephenson JJ, Wood BL, Feldman EJ, Galili N, Grove LE, Drachman JG, Sievers EL. Complete remissions observed in acute myeloid leukemia following prolonged exposure to lintuzumab: a phase 1 trial. Leuk Lymphoma. 2009 Aug;50(8):1336-44. doi: 10.1080/10428190903050013.

    PMID: 19557623RESULT

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic SyndromesMyeloproliferative DisordersLeukemia, Myelomonocytic, ChronicHematologic DiseasesLeukemia

Interventions

lintuzumab

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHemic and Lymphatic DiseasesBone Marrow DiseasesMyelodysplastic-Myeloproliferative DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eric Sievers, M.D.

    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

January 25, 2006

First Posted

January 27, 2006

Study Start

November 1, 2005

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations

US(9)