|- candidate number||1873|
|- NTR Number||NTR529|
|- Date ISRCTN created||14-feb-2006|
|- date ISRCTN requested||13-jan-2006|
|- Date Registered NTR||30-nov-2005|
|- Secondary IDs||HO68 |
|- Public Title||A randomized phase III study in previously untreated patients with biological high-risk CLL: Fludarabine + cyclophosphamide (FC) versus FC + low-dose alemtuzumab.|
|- Scientific Title||A randomized phase III study in previously untreated patients with biological high-risk CLL: Fludarabine + cyclophosphamide (FC) versus FC + low-dose alemtuzumab.|
|- ACRONYM||HOVON 68 CLL|
|- hypothesis||The hypothesis to be tested is that the outcome in arm B is better than in arm A.|
|- Healt Condition(s) or Problem(s) studied||Chronic Lymfocytic Leukemia (CLL)|
|- 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.
|- Exclusion criteria||1. WHO performance status >= 3, unless related to CLL;|
2. Intolerance of exogenous protein administration;
3. Severe cardiac dysfunction (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 ULN), unless related to CLL;
6. Suspected or documented 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||5-dec-2005|
|- planned closingdate||31-dec-2008|
|- Target number of participants||300|
|- Interventions||All eligible patients will be randomized on entry between:|
1. Arm A: 6 cycles of oral FC;
2. Arm B: 6 cycles of oral FC combined with s.c. alemtuzumab.
|- Primary outcome||Progression free survival (i.e. time from registration to disease progression, relapse or death due to CLL whichever occurs first).|
|- Secondary outcome||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);
|- Trial web site||http://www.hovon.nl|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. M.H.J. Oers, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. C.H. Geisler|
|- Sponsor/Initiator ||Rigshospitalet|
(Source(s) of Monetary or Material Support)
|Dutch Cancer Society, Schering AG|
|- Brief summary||Study phase: Phase III|
Study objectives: Determination of the efficacy and safety of oral fludarabine and cyclophosphamide plus concomitant s.c. alemtuzumab compared to fludarabine and cyclophosphamide alone in terms of progression free survival, event free survival, clinical, flow cytometric and molecular response rates, overall survival and disease free survival.
Patient population: Patients with biological high-risk CLL in symptomatic stage A or B or stage C, irrespective of duration of disease, age 18-75 years inclusive.
Study design: Prospective, multicenter, randomized
Duration of treatment: Expected duration of treatment is 24 weeks.
|- Main changes (audit trail)|
|- RECORD||30-nov-2005 - 6-mrt-2006|