Dose-finding Trial of HCD122 in Patients With Chronic Lymphocytic Leukemia (CLL) That is Relapsed or Non-responsive to Prior Fludaribine Therapy

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with chronic lymphocytic leukemia who are relapsed after receiving prior treatment.

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Detailed Description

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Conditions

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Chronic Lymphocytic 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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HCD122

Group Type EXPERIMENTAL

HCD122

Intervention Type DRUG

Interventions

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HCD122

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of CLL requiring treatment
* Refractory or relapsed disease
* Prior treatment with fludarabine
* Male or Female
* \>18 years of age

Exclusion Criteria

* Treatment with rituximab within 90 days and alemtuzumab or any monoclonal antibody within 6 months.
* Clinically significant cardiac dysfunction or other significant organ dysfunction

Additional eligibility criteria apply that will be reviewed with potential study subjects at the site.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No