The hypothesis to be tested is that the outcome in arm B is better than in arm A.
ID
Bron
Verkorte titel
Aandoening
Chronic Lymphocytic Leukemia
Ondersteuning
Rigshospitalet
Dept. of Hematology (L 4042)
Blegdamsvej 9
DK-2100 Copenhagen
Denmark
Tel: 0045 35451146
Fax: 0045 35454283
e-mail:geisler@rh.dk
HOVON receives unrestricted grants and/or financial support from Amgen, Johnson&Johnson-Orthobiotech, Roche and Novartis for the execution of investigator sponsored trials. In addition HOVON is supported by the Dutch Cancer Society.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Progression free survival (i.e. time from registration to disease progression, relapse or death due to CLL whichever occurs first).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The hypothesis to be tested is that the outcome in arm B is better than in arm A.
Onderzoeksproduct en/of interventie
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.
Publiek
Department of Hematology,
P.O. Box 22660
M.H.J. Oers, van
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665785
m.h.vanoers@amc.uva.nl
Wetenschappelijk
Department of Hematology,
P.O. Box 22660
M.H.J. Oers, van
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665785
m.h.vanoers@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL487 |
| NTR-old | NTR529 |
| Ander register | : HO68 |
| ISRCTN | ISRCTN25180151 |