Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL)
This study has been completed.
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00046488
First received: September 30, 2002
Last updated: June 7, 2012
Last verified: May 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia |
Drug: IDEC-152 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| 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 |
Resource links provided by NLM:
Further study details as provided by Biogen Idec:
Primary Outcome Measures:
- Determine a recommended Phase II dose for the treatment of patients with relapsed or refractory CLL [ Time Frame: 48 months ] [ Designated as safety issue: No ]
- Characterize the safety profile of IDEC-152 [ Time Frame: 48 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL [ Time Frame: 48 months ] [ Designated as safety issue: No ]
- Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL [ Time Frame: 48 months ] [ Designated as safety issue: No ]
| Enrollment: | 70 |
| Study Start Date: | September 2002 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: IDEC-152
6 Dosing groups: 125mg/m2 weekly x 4, 250mg/m2 weekly x 4, 375mg/m2 weekly x 4, 500mg/m2 weekly x 4, 500mg/m2 3 times first week then weekly x 3, 500mg/m2 3 times per week x 4
Other Name: Lumiliximab
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00046488
Locations
| United States, California | |
| Research Site | |
| La Jolla, California, United States | |
| Research Site | |
| LaJolla, California, United States | |
| United States, Maryland | |
| Research Site | |
| Baltimore, Maryland, United States | |
| United States, New York | |
| Research Site | |
| New Hyde Park, New York, United States | |
| Research Site | |
| New York, New York, United States | |
| United States, Ohio | |
| Research Site | |
| Columbus, Ohio, United States | |
| United States, Texas | |
| Research Site | |
| Houston, Texas, United States | |
Sponsors and Collaborators
Biogen Idec
More Information
Publications:
| Responsible Party: | Study MD, Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00046488 History of Changes |
| Other Study ID Numbers: | 152-20 |
| Study First Received: | September 30, 2002 |
| Last Updated: | June 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Biogen Idec:
|
Chronic Lymphoblastic Leukemia Leukemia, Lymphoblastic, Chronic Chronic Lymphocytic Leukemia CLL |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms |
Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013