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A Phase I Multicenter, Dose-Escalation Study of IDEC-152 (Anti-CD23 Monoclonal Antibody) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia

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Trial Information

A Phase I Multicenter, Dose-Escalation Study of IDEC-152 (Anti-CD23 Monoclonal Antibody) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia


Inclusion Criteria:



- Signed IRB-approved informed consent.

- Greater than 18 years of age

- Proof of CD23+ CLL or small lymphocytic lymphoma (SLL)

- Progressive disease after at least 1 course of chemotherapy

- Acceptable hematologic status, liver function, renal function, and pulmonary function

- Patients of reproductive potential must agree to follow accepted birth control
methods during treatment and for 3 months after completion of treatment

Exclusion Criteria:

- Previous exposure to IDEC-152 or other anti-CD23 antibodies

- Presence of HIV infection or AIDS

- Serious nonmalignant disease

- Active uncontrolled bacterial, viral or fungal infections.

- Clinically active autoimmune disease

- Pregnant or currently breast feeding

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL

Outcome Time Frame:

48 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

152-20

NCT ID:

NCT00046488

Start Date:

September 2002

Completion Date:

March 2010

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Chronic Lymphoblastic Leukemia
  • Leukemia, Lymphoblastic, Chronic
  • Chronic Lymphocytic Leukemia
  • CLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Research SiteAnaheim, California  
Research SiteBaltimore, Maryland  
Research SiteAlbany, New York  
Research SiteAkron, Ohio  
Research SiteAbilene, Texas