NCT00162851

Brief Summary

This is a Phase II trial to study the safety and tolerability of subcutaneous alemtuzumab administered without dose escalation to patients with advanced B-cell chronic lymphocytic leukemia (B-CLL).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2003

Typical duration for phase_2

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

April 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

July 25, 2007

Status Verified

August 1, 2005

First QC Date

September 8, 2005

Last Update Submit

July 23, 2007

Conditions

B-CLL

Interventions

alemtuzumabDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • B-CLL that has failed fludarabine

You may not qualify if:

  • Performance status grade 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Hematology, Karolinska University Hospital

Stockholm, SE-171 76, Sweden

Location

MeSH Terms

Interventions

Alemtuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Anders C Osterborg, Professor

    Dept. of Hematology, Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 13, 2005

Study Start

April 1, 2003

Study Completion

July 1, 2006

Last Updated

July 25, 2007

Record last verified: 2005-08

Locations

SE(1)