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

Novartis

Status and phase: Terminated; Phase 1

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: HCD122

Study type: Interventional

Funder types: Industry

Identifiers

NCT00108108

CHCD122A2101

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

HCD122

Experimental group

Treatment:

Drug: HCD122