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A Safety Study of Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

NCT ID: NCT00283114

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myeloid Leukemia Myelodysplastic Syndrome Myeloproliferative Disorders Chronic Myelomonocytic Leukemia

Keywords

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Lintuzumab Antigens, CD33 Antibodies, Monoclonal Leukemia, Myeloid, Acute Myelodysplastic Syndromes Hematologic Diseases Myeloproliferative Disorders Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

lintuzumab

Intervention Type DRUG

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

Interventions

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lintuzumab

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

Intervention Type DRUG

Other Intervention Names

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SGN-33

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seagen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Sievers, M.D.

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

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Rocky Mountain Cancer Center

Denver, Colorado, United States

Site Status

Cancer Care Specialists of Central Illinois

Decatur, Illinois, United States

Site Status

Indiana Oncology-Hematology Consultants

Indianapolis, Indiana, United States

Site Status

University of Massachusetts Medical Center

Worcester, Massachusetts, United States

Site Status

St. Vincent's Comprehensive Cancer Center

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Weill Medical College of Cornell University

New York, New York, United States

Site Status

Cancer Center of the Carolinas

Greenville, South Carolina, United States

Site Status

Scott & White Memorial Hospital

Temple, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19557623 (View on PubMed)

Other Identifiers

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SG033-0001

Identifier Type: -

Identifier Source: org_study_id