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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25345

Enrollment

300

Registered

2005-11-30

Start date

2005-12-05

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Chronic Lymphocytic Leukemia

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.

Eligibility

Inclusion criteria

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

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 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.

Design outcomes

Primary

Measure	Time frame
Progression free survival (i.e. time from registration to disease progression, relapse or death due to CLL whichever occurs first).	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactM.H.J. Oers, van

Academic Medical Center (AMC), Department of Hematology, P.O. Box 22660

m.h.vanoers@amc.uva.nl+31 (0)20 5665785

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)