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A Safety Study in Patients With Chronic Lymphocytic Leukemia

NCT00283101 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2014-12-18

No results posted yet for this study

Summary

This is an open-label, dose-escalation study to determine the tolerability, safety profile, and antitumor activity of SGN-40 in patients with CLL. All patients will receive dose escalation during the first two weeks regardless of cohort designation.

Conditions

  • Leukemia, Lymphocytic, Chronic

Interventions

DRUG

SGN-40 (anti-huCD40 mAb)

1-8 mg/kg IV; Days 1, 4, 8, 15, 22, 29 of Cycle 1 and Days 1, 15, 29 and 43 of Cycles 2-6.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Jonathan Drachman, MD · Seagen Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00283101 on ClinicalTrials.gov