A randomized phase III study in previously untreated patients with biological high-risk CLL: fludarabine and cyclophosphamide (FC) versus FC and low-dose alemtuzumab
| ISRCTN | ISRCTN25180151 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25180151 |
| Secondary identifying numbers | HO68 |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 14/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof M.H.J. Oers, van
Scientific
Scientific
Academic Medical Center
Department of Hematologie
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5665785 |
|---|---|
| m.h.vanoers@amc.uva.nl |
Study information
| Study design | Prospective, multicenter, randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HOVON 68 CLL |
| Study objectives | The hypothesis to be tested is that the outcome in arm B is better than in arm A. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Fludarabine and cyclophosphamide (FC) and low-dose alemtuzumab |
| Primary outcome measure | 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 study start date | 05/12/2005 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 300 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 05/12/2005 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Rigshospitalet (Denmark)
Hospital/treatment centre
Hospital/treatment centre
Department of Hematology
Copenhagen
DK-2100
Denmark
"ROR" |
https://ror.org/03mchdq19 |
|---|
Funders
Funder type
Industry
Dutch Cancer Society and Schering AG (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
