HOVON 68 CLL: A randomized phase III study in prevously untreated patients with biological high risk CLL: Fludarabine + cyclophosphamide (FC) versus FC + low-dose alemtuzumab. - HOVON68

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000309-75-FI

Enrollment

300

Registered

2005-08-31

Start date

2006-06-26

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic lymphocytic leukaemia (CLL) in biological high-risk group: Unmutated and/or with deletion 17p and/or deletion 11q and/or trisomy 12.

Interventions

Trade Name: MabCampath Product Name: MabCampath Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Alemtuzumab CAS Number: 216503-57-0 Concentration unit: mg/ml milligram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Biological high-risk CLL* Patients with symptomatic ** stage A, symptomatic** stage B or stage C Age 18-75 years inclusive Written informed consent * Biological hig risk CLL 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: WHO performance status >= 3 unless related to CLL Intolerance of exogenous protein asministration severe cardiac dysfunction significant renal dysfunction (serum creatinine >= 150 micromol/l or creatinine clearance 2 times ULN) unless related to CLL Suspected or documented CNS involvement by CLL

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effect of addition of alemtuxumab s.c. to 6 courses of oral FC in terms of progression-free survival;Secondary Objective: To assess the effect of addition of alemtuxumab s.c. to 6 courses of oral FC in terms of: - event-free survival - clinical, flow cytometric and molecular response rate - Overall survival - Disease-free survival - Toxicity To assess the effect of addition of alemtuxumab s.c. to 6 courses of oral FC with respect to the incidence of severe opportunistic infections (CMV reactivation, CMV disease, Herpes simplex and Herpes zoster infections, EBV ractivation, deep mycosis, mycobacterial infections, other infections) and infections due to neutropenia.;Primary end point(s): Progression-free survival	—

Measure

Time frame

Main Objective: To assess the effect of addition of alemtuxumab s.c. to 6 courses of oral FC in terms of progression-free survival;Secondary Objective: To assess the effect of addition of alemtuxumab s.c. to 6 courses of oral FC in terms of: - event-free survival - clinical, flow cytometric and molecular response rate - Overall survival - Disease-free survival - Toxicity To assess the effect of addition of alemtuxumab s.c. to 6 courses of oral FC with respect to the incidence of severe opportunistic infections (CMV reactivation, CMV disease, Herpes simplex and Herpes zoster infections, EBV ractivation, deep mycosis, mycobacterial infections, other infections) and infections due to neutropenia.;Primary end point(s): Progression-free survival

—

Countries

Belgium, Czech Republic, Denmark, Finland, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026