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A Phase 1-2, Multicenter, Open-Label Study of AEG35156 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia and Indolent B-Cell Lymphomas

NCT00768339 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2011-07-13

No results posted yet for this study

Summary

AEG35156 has shown early evidence of activity in patients with advanced indolent B-cell lymphomas in Phase 1 trials and merits further evaluation in this disease. This trial is designed to determine the recommended dose of AEG35156 in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and indolent B-cell lymphomas.

Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma, B-Cell

Interventions

DRUG

AEG35156 antisense IV infusion

AEG35156 will be given as a 2-hour intravenous infusion (escalating dose 50, 100, 150, 200, 250 and 300 mg) once weekly on Day 1, Day 8 and Day 15. One cycle of therapy will consist of 21 days. Patients will be treated until disease progression. * Patients must be pretreated for at least three days with allopurinol prior to the first dose of AEG35156 and throughout protocol therapy. * Patients must be hydrated with 1 L of normal saline prior AEG35156 infusion

Sponsors & Collaborators

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • Aegera Therapeutics

    lead INDUSTRY

Principal Investigators

  • John Sweetenham, MD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2011-06-30
Completion
2011-09-30

Countries

  • United States
  • Canada

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 NCT00768339 on ClinicalTrials.gov