Condition category
Cancer
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
14/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof M.H.J. Oers, van

ORCID ID

Contact details

Academic Medical Center
Department of Hematologie
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5665785
m.h.vanoers@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HO68

Study information

Scientific title

Acronym

HOVON 68 CLL

Study hypothesis

The hypothesis to be tested is that the outcome in arm B is better than in arm A.

Ethics approval

Not provided at time of registration

Study design

Prospective, multicenter, randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Chronic Lymphocytic Leukemia (CLL)

Intervention

All eligible patients will be randomized on entry between:
Arm A: 6 cycles of oral FC
Arm B: 6 cycles of oral FC combined with sc alemtuzumab

Intervention type

Drug

Phase

Phase III

Drug names

Fludarabine and cyclophosphamide (FC) and low-dose alemtuzumab

Primary outcome measures

Progression free survival (i.e. time from registration to disease progression, relapse or death due to CLL whichever occurs first)

Secondary outcome measures

1. Event free survival (i.e. time from registration to induction failure, progression, relapse or death whichever occurs first); the time to failure of patients with induction failure is set at one day
2. Clinical, flow cytometric and molecular response rate
3. Overall survival
4. Disease free survival (i.e. time from CR to relapse)
5. Toxicity

Overall trial start date

05/12/2005

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Biological high-risk CLL
2. Patients with symptomatic stage A, symptomatic stage B or stage C
3. Age 18-75 years inclusive
4. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. WHO performance status >/= 3, unless related to CLL
2. Intolerance of exogenous protein administration
3. Severe cardiac dysfunction (New York Heart Association [NYHA] classification III-IV)
4. Significant renal dysfunction (serum creatinine >/= 150 micromol/l or creatinine clearance <30 ml/min)
5. Significant hepatic dysfunction (total bilirubin or transaminases >2 times upper limit of normal [ULN]), unless related to CLL
6. Suspected or documented central nervous system (CNS) involvement by CLL
7. Known HIV positivity
8. Active, uncontrolled infections
9. Uncontrolled asthma or allergy requiring systemic steroid treatment
10. Previously treated with chemotherapy, radiotherapy or immunotherapy for CLL
11. History of active cancer during the past 5 years, except non-melanoma skin cancer or stage 0 cervical carcinoma
12. Clinically significant auto-immune hemolytic anemia (AIHA)
13. Female patients who are pregnant or nursing
14. Male and female patients of reproductive potential who are not practicing effective means of contraception, these include oral contraceptives, intrauterine device, depot injection of gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot plaster. These methods must be applied for the entire protocol treatment period, and for patients treated with alemtuzumab until at least 6 months after the end of alemtuzumab administration.

Recruitment start date

05/12/2005

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Rigshospitalet (Denmark)

Sponsor details

Department of Hematology
Copenhagen
DK-2100
Denmark

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Dutch Cancer Society and Schering AG (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes