Clinical trial NCT00046488: Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL)
Official title: A Phase I Multicenter, Dose-Escalation Study of IDEC-152 (Anti-CD23 Monoclonal Antibody) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphoblastic Leukemia
Leukemia, Lymphoblastic, Chronic
Chronic Lymphocytic Leukemia
CLL
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2002-10-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To determine what side effects and what clinical effects if any the administration of this investigational product, IDEC-152 (an antibody against CD23 which is an important protein on leukemia cells and certain cells in the body's immune system), has on the CLL patient population.


Eligibility criteria: 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

Primary outcomes:
measure: Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL
timeFrame: 48 months
measure: Characterize the safety profile of IDEC-152
timeFrame: 48 months
Secondary outcomes:
measure: Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL
timeFrame: 48 months
measure: Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL
timeFrame: 48 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Research Site
state: California
city: LaJolla
country: United States
facility: Research Site
state: California
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: New Hyde Park
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Houston
country: United States
facility: Research Site
state: Texas
Study officials:
References:
citation: Byrd JC, O'Brien S, Flinn IW, Kipps TJ, Weiss M, Rai K, Lin TS, Woodworth J, Wynne D, Reid J, Molina A, Leigh B, Harris S. Phase 1 study of lumiliximab with detailed pharmacokinetic and pharmacodynamic measurements in patients with relapsed or refractory chronic lymphocytic leukemia. Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4448-55. doi: 10.1158/1078-0432.CCR-06-1463.
citation: Pathan NI, Chu P, Hariharan K, Cheney C, Molina A, Byrd J. Mediation of apoptosis by and antitumor activity of lumiliximab in chronic lymphocytic leukemia cells and CD23+ lymphoma cell lines. Blood. 2008 Feb 1;111(3):1594-602. doi: 10.1182/blood-2007-03-082024. Epub 2007 Nov 21.