NCT00046488

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2002

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

September 16, 2013

Status Verified

May 1, 2010

Enrollment Period

1.6 years

First QC Date

September 30, 2002

Last Update Submit

September 12, 2013

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphoblastic LeukemiaLeukemia, Lymphoblastic, ChronicChronic Lymphocytic LeukemiaCLL

Outcome Measures

Primary Outcomes (2)

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

    48 months

  • Characterize the safety profile of IDEC-152

    48 months

Secondary Outcomes (2)

  • Evaluate the pharmacokinetics and pharmacodynamics of IDEC-152 in patients with relapsed or refractory CLL

    48 months

  • Evaluate the efficacy of IDEC-152 in patients with relapsed or refractory CLL

    48 months

Interventions

IDEC-152DRUG

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

Also known as: Lumiliximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

La Jolla, California, United States

Location

Research Site

Baltimore, Maryland, United States

Location

Research Site

New Hyde Park, New York, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Columbus, Ohio, United States

Location

Research Site

Houston, Texas, United States

Location

Related Publications (2)

  • 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.

    PMID: 17671129BACKGROUND

  • 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.

    PMID: 18032710BACKGROUND

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

lumiliximab

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 30, 2002

First Posted

October 2, 2002

Study Start

September 1, 2002

Primary Completion

April 1, 2004

Study Completion

March 1, 2010

Last Updated

September 16, 2013

Record last verified: 2010-05

Locations

US(6)