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
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