NCT00344825

Brief Summary

300 patients, starting a new pharmacological treatment for B-CLL, were enrolled by 36 Italian Centres for assessing the Quality of Life (QoL). A descriptive analysis of QoL and the correlation of the age, sex, stage of disease, Time from first B-CLL diagnosis, Number of previous B-CLL treatments, reason of starting of the new B-CLL treatment: therapeutic Regimen, type of Centre, B-CLL treatment lasting, response to B-CLL treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Typical duration for all trials

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

January 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

December 4, 2013

Status Verified

December 1, 2013

Enrollment Period

2.8 years

First QC Date

June 26, 2006

Last Update Submit

December 2, 2013

Conditions

Leukemia, B-Cell, Chronic

Keywords

B- Chronic Lymphocytic Leukemia

Study Arms (1)

Group 1

Drug: Alemtuzumab (MabCampath, BAY86-5045) and Fludarabine Phosphate (Fludara, BAY86-4864)

Interventions

Alemtuzumab (MabCampath, BAY86-5045) and Fludarabine Phosphate (Fludara, BAY86-4864)DRUG

Descriptive statistical methods applied for the whole study cohort and for subgroups according to QoL and the correlation of the following parameters: Age, Sex, Stage of disease, Time from first B-CLL diagnosis, number of previous B-CLL treatments, Reason of starting of the new B-CLL treatment (progression disease, relapse, no-response to the previous treatment, previous treatment toxicity), Therapeutic Regimen (Day Hospital, Hospital Admission, etc.), Type of Centre, B-CLL treatment lasting, Response to B-CLL treatment. QoL at baseline, Change in QoL over time evaluated using an analysis of Variance.

Group 1

Eligibility Criteria

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

Patients, aged \>/= 18 years, either sex with B-CLL, who are starting a new pharmacological treatment for B-CLL (1st, 2nd, 3rd, 4th), duration of CLL therapy \</= 6 months, WHO Performance Status \&#8804; 2, life expectancy \>/= 6 months

You may qualify if:

  • Aged \>/=18 years
  • Patients of either sex with B-CLL, who are starting a new pharmacological treatment for B-Chronic Lymphocytic Leukemia (1st, 2nd, 3rd, 4th)
  • Foreseen duration of CLL therapy \</= 6 months
  • B-Chronic Lymphocytic Leukemia progressive stage A, stage B or C (according to Binet system), or II-IV (according to Rai system)
  • WHO Performance Status \</= 2
  • Life expectancy \</= 6 months
  • Signed Informed consent for personal data's treatment and availability to fill in the QoL questionnaire

You may not qualify if:

  • Patients with any other tumour disease
  • Chronic Lymphocytic Leukemia therapy in the last 30 days before V0
  • More than 3 previous CLL treatments (the therapy is defined by the drug and/or the treatment period)
  • Previous stem cells transplantation
  • Concurrent or in the last 30 days participation to any other clinical trial
  • Any medical or psychological conditions that might compromise the capacity to sign the consent for personal data's treatment or to fill in the QoL questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Italy

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLeukemia, B-Cell

Interventions

Alemtuzumabfludarabine phosphate

Condition Hierarchy (Ancestors)

Leukemia, 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

Study Record Dates

First Submitted

June 26, 2006

First Posted

June 27, 2006

Study Start

January 1, 2004

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

December 4, 2013

Record last verified: 2013-12

Locations

IT(1)