NCT00593944

Brief Summary

The purpose of this study is to see at what dose MDX-1342, a monoclonal antibody, is safe and tolerable for patients with chronic lymphocytic leukemia (CLL). Information on any responses that patients may have to the drug will also be collected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 22, 2013

Status Verified

May 1, 2013

Enrollment Period

1.7 years

First QC Date

January 3, 2008

Last Update Submit

May 21, 2013

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLLChronic Lymphocytic LeukemiaB cellleukemialymphocyteantibodymonoclonalcancerblood

Outcome Measures

Primary Outcomes (1)

  • incidence and severity of treatment-emergent adverse events

    all events will be followed to resolution

Secondary Outcomes (6)

  • response

    12 weeks

  • clinical laboratory tests

    study duratation - each visit

  • physical examination

    study duration - each visit

  • electrocardiogram

    at screening and study completion

  • diagnostic testing

    at screening and study completion

  • +1 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

Patients will receive active MDX-1342.

Biological: MDX-1342

Interventions

MDX-1342BIOLOGICAL

MDX-1342 is given as a 90 minute i.v. infusion. Patients will receive one of the following dose levels, 0.7, 7, 40, 200, 1000, 2000 mg/dose.

1

Eligibility Criteria

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

You may qualify if:

  • relapsed/refractory CD19-positive CLL
  • At least 28 days since prior treatment for CLL
  • ECOG PS 0-2
  • Screening laboratory values must be met

You may not qualify if:

  • No prior anti-CD19 antibody tx
  • No active, uncontrolled infection
  • No prior allogeneic bone marrow transplant
  • No autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Oncology Consultants, PA

Houston, Texas, 77024, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLeukemiaNeoplasms

Interventions

MDX-1342 antibody

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 15, 2008

Study Start

August 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 22, 2013

Record last verified: 2013-05

Locations

US(3)