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A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

NCT00496132 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-07-02

No results posted yet for this study

Summary

This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with chronic lymphocytic leukemia (CLL) who have relapsed after or were refractory to treatment with a purine nucleoside analogue-containing regimen. The trial will enroll in two phases: a Phase I dose-escalation portion and a Phase II expanded treatment cohort, with enrollment of additional patients in order to expand safety experience and collect preliminary anti-leukemia activity data.

Conditions

Interventions

DRUG

PRO131921

Escalating doses by IV infusion

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Bill Ho, M.D. · Genentech, 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
2007-08-27
Primary Completion
2009-06-17
Completion
2009-06-17

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Entities

Diseases

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 NCT00496132 on ClinicalTrials.gov