NCT00089154

Brief Summary

This phase II trial is studying how well apolizumab works in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Monoclonal antibodies such as apolizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

2 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

August 1, 2004

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Last Updated

July 16, 2013

Status Verified

June 1, 2013

Enrollment Period

1.2 years

First QC Date

August 4, 2004

Last Update Submit

July 15, 2013

Conditions

Noncontiguous Stage II Small Lymphocytic LymphomaRecurrent Small Lymphocytic LymphomaRefractory Chronic Lymphocytic LeukemiaStage III Small Lymphocytic LymphomaStage IV Small Lymphocytic Lymphoma

Outcome Measures

Primary Outcomes (3)

  • Response rate (CR+PR)

    Up to 3 years

  • Progression-free survival rate

    Up to 3 years

  • Frequency and severity of treatment-related adverse events

    Up to 30 days

Secondary Outcomes (1)

  • Pharmacokinetic clearance

    Days 1, 2, 3, 5, 8, 15, 22, 26, 27, 29 and 1, 2, 3, and 6 months

Study Arms (1)

Treatment (apolizumab)

EXPERIMENTAL

Patients receive apolizumab IV over 2-4 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 in the absence of disease progression or unacceptable toxicity.

Biological: apolizumabOther: laboratory biomarker analysisOther: pharmacological study

Interventions

apolizumabBIOLOGICAL

Given IV

Also known as: 1D1O Anti-lymphoma Antibody, MOAB 1D10, MoAb Hu1D10, Monoclonal antibody 1D10, Monoclonal Antibody Hu1D10
Treatment (apolizumab)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (apolizumab)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (apolizumab)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed hematologic malignancy of 1 of the following histologies:
  • Chronic lymphocytic leukemia (CLL)
  • Small lymphocytic lymphoma (SLL)
  • Noncontiguous stage II or stage III or IV disease
  • Received \>= 1 form of prior immunotherapy or chemotherapy
  • Completed therapy at least 4 weeks ago
  • Requires therapy (unless early bone marrow transplantation is planned), as indicated by 1 of the following criteria:
  • Progressively worsening disease (symptoms increasing in severity by 1 toxicity criterion over a period of \>= 2 weeks)
  • Progressively worsening anemia or thrombocytopenia
  • Progressively worsening lymphadenopathy
  • Massive splenomegaly or hypersplenism
  • Hyperlymphocytosis (WBC \> 200,000/mm\^3) OR lymphocyte doubling time \< 12 months
  • Marrow failure due to marrow infiltration by leukemia or lymphoma
  • Leukemia cells must express 1D10 antigen \> 2 times mean fluorescent intensity of the control by flow cytometry of blood or bone marrow cells
  • Performance status - ECOG 0-2
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chronic Lymphocytic Leukemia Research Consortium (CRC)

La Jolla, California, 92093-0820, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

apolizumab

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 Officials

  • John Byrd

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2004

First Posted

August 5, 2004

Study Start

August 1, 2004

Primary Completion

October 1, 2005

Last Updated

July 16, 2013

Record last verified: 2013-06

Locations

US(2)