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HOVON 68

HOVON 68. A randomized phase III study in previously untreated patients with biological high-risk CLL: Fludarabine + cyclophosphamide (FC) versus FC + low-dose alemtuzumab. Arm-A: FC FC every 4 weeks for 6 cycles. ARM-B: FC + Alemtuzumab (Total dose 240 mg).

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HOVON 68

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  1. HOVON 68 A randomized phase III study in previously untreated patients with biological high-risk CLL: Fludarabine + cyclophosphamide (FC) versus FC + low-dose alemtuzumab

  2. Arm-A: FCFC every 4 weeks for 6 cycles

  3. ARM-B: FC + Alemtuzumab(Total dose 240 mg)

  4. Type of study: A Phase III Study • Target number of patients:300 patients registered and randomized • Date of activation:05 December 2005 • Date closed:- • Approval:- • Czech Republic:-- • Denmark:26 August 2005- • Finland:-- • The Netherlands CKTO:08 September 2005- The Netherlands METC:24 November 2005 • Norway:23 June 2005- • Poland:13 February 2006- • Sweden:

  5. Patient Eligibility Criteria: Inclusion Criteria • Biological high-risk CLL*; • Patients with symptomatic** stage A, symptomatic** stage B or stage C (see appendix B); • Age 18-75 years inclusive; • Written informed consent. • * Biological high risk is defined as: >= 98 % homology of IgVH genes with germ-line sequences and/or FISH with 17p deletions and/or 11q deletions and/or trisomy 12.** Symptomatic CLL is defined according to the NCI criteria for active disease (Cheson et al. 1996, see appendix A).

  6. Exclusion Criteria • WHO performance status >= 3 (see appendix E), unless related to CLL; • Intolerance of exogenous protein administration; • Severe cardiac dysfunction (NYHA classification III-IV, see appendix F); • Significant renal dysfunction (serum creatinine >= 150 µmol/l or creatinine clearance < 30 ml/min); • Significant hepatic dysfunction (total bilirubin or transaminases > 2 times ULN), unless related to CLL; • Suspected or documented CNS involvement by CLL; • Known HIV positivity; • Active, uncontrolled infections; • Uncontrolled asthma or allergy requiring systemic steroid treatment;

  7. Exclusion Criteria II • Previously treated with chemotherapy, radiotherapy or immunotherapy for CLL; • History of active cancer during the past 5 years, except non-melanoma skin cancer or stage 0 cervical carcinoma; • Clinically significant auto-immune hemolytic anemia (AIHA); • Female patients who are pregnant or nursing; • 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.

  8. Registration and Randomization of Patients: • Central registration at the HOVON Data Center: Erasmus MC - Daniel den Hoed P.O.Box 5201 3008 AE ROTTERDAM The Netherlands Tel: +31.10.4391568 (working days 9.00-17.00) Fax: +31.10.4391028 TOP: https://www.hdc.hovon.nl/top

  9. The following information will be requested: • Protocol number • Institution name • Name of caller/responsible investigator • Patient’s initials or code • Patient’s hospital record number • Sex • Date of birth • Date of diagnosis CLL • Eligibility criteria

  10. Study Coordinators:Christian Geisler (christian.geisler@rh.hosp.dk) Rien van Oers (m.h.vanoers@amc.uva.nl) Statistician:Wim van Putten (w.vanputten@erasmusmc.nl) Central Datamanagement:Christel van Hooije (c.vanhooije@erasmusmc.nl)

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