NCT00058396

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

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

October 1, 2002

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Last Updated

May 30, 2013

Status Verified

December 1, 2009

Enrollment Period

2 years

First QC Date

April 7, 2003

Last Update Submit

May 29, 2013

Conditions

LeukemiaLymphoma

Keywords

refractory chronic lymphocytic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemianoncontiguous stage II small lymphocytic lymphomarecurrent small lymphocytic lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomacontiguous stage II small lymphocytic lymphoma

Interventions

lumiliximabBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed chronic lymphocytic leukemia OR small lymphocytic lymphoma * Stage III-IV OR * Stage I-II, if determined to have disease progression evidenced by 1 of the following characteristics: * Rapid doubling of peripheral lymphocyte count * Progressive lymphadenopathy * Progressive splenomegaly * B symptoms * Grade 2 or 3 fatigue * CD23+ disease * Progressive disease after at least 1 prior chemotherapy course PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 Life expectancy * At least 6 months Hematopoietic * Platelet count at least 50,000/mm\^3 Hepatic * Bilirubin no greater than 2.0 mg/dL * AST/ALT no greater than 1.5 times upper limit of normal (ULN) Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * No New York Heart Association class III or IV cardiac disease * No myocardial infarction within the past 6 months * No unstable arrhythmia * No evidence of ischemia on EKG within the past 14 days Pulmonary * FEV\_1 at least 60% of predicted * DLCO at least 55% of predicted Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study treatment * HIV negative * No secondary malignancy requiring active treatment (except hormonal therapy) * No serious nonmalignant disease that would preclude study participation * No active uncontrolled bacterial, viral, or fungal infection * No clinically active autoimmune disease PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior anticancer biologic therapy * More than 4 weeks since prior anticancer radioimmunotherapy * No prior exposure to IDEC-152 or anti-CD23 antibodies Chemotherapy * See Disease Characteristics * More than 4 weeks since prior anticancer chemotherapy Endocrine therapy * Concurrent hormonal therapy allowed for second malignancy Radiotherapy * More than 4 weeks since prior anticancer radiotherapy Surgery * More than 4 weeks since prior major surgery (except for diagnostic surgery) Other * More than 4 weeks since prior anticancer investigational therapy * No other concurrent anticancer therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

lumiliximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mark Adam Weiss, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2003

First Posted

April 9, 2003

Study Start

October 1, 2002

Primary Completion

October 1, 2004

Last Updated

May 30, 2013

Record last verified: 2009-12

Locations

US(1)