NCT00836043

Brief Summary

This study will collect data on safety, effectiveness and patient acceptance of MabCampath treatment under daily life conditions.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 for all trials

Geographic Reach
3 countries

3 active sites

Status
terminated

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, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

December 3, 2013

Status Verified

December 1, 2013

Enrollment Period

6 months

First QC Date

February 2, 2009

Last Update Submit

December 2, 2013

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLLalemtuzumab

Outcome Measures

Primary Outcomes (1)

  • Efficacy related variables are patient's condition, physician's assessment of efficacy and tolerability, information whether application could be completed, clinical and laboratory findings. Safety Variables.

    After first cycle of treatment, e.g. 12 weeks, then after 9 months

Study Arms (1)

Group 1

Drug: Alemtuzumab (MabCampath)

Interventions

Alemtuzumab (MabCampath)DRUG

Intravenous therapy according to product information.

Also known as: BAY86-5045
Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients,who are suffering from chronic lymphocytic leukemia (CLL) and are treated with alemtuzumab (MabCampath)

You may qualify if:

  • In- and outpatients suffering from CLL, who are treated with Mab Campath, and are routinely monitored with PCR (Polymerase Chain Reaction) for CMV infection during MabCampath treatment and for at least 2 months following completion of treatment.

You may not qualify if:

  • In accordance with Summaries of Product Characteristics (SPC).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Many Locations, Bosnia and Herzegovina

Location

Unknown Facility

Many Locations, Israel

Location

Unknown Facility

Many Locations, North Macedonia

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Alemtuzumab

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Medical Monitor

    Genzyme, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 4, 2009

Study Start

October 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

December 3, 2013

Record last verified: 2013-12

Locations

IL(1)BO(1)NO(1)