The hypothesis to be tested is that the outcome in arm B is better than in arm A.
ID
Bron
Verkorte titel
Aandoening
Non Hodgkin’s Lymphoma.
Ondersteuning
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 4391568
Fax: 010 4391028
e-mail: hdc@erasmusmc.nl
Koningin Wilhelmina Fonds (KWF)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
CR rate and overall survival.
Achtergrond van het onderzoek
Study phase:
phase III.
Study objective:
evaluation of the effect of intensified CHOP q 2 weeks + G-CSF with respect to CR rate and disease-free and overall survival.
Patient population:
patients with primary NHL (groups D,E,F,G,H), intermediate risk, age 15-65 years inclusive.
Study design: prospective, multicenter, randomized.
Duration of treatment:
expected duration of treatment is 24 weeks for arm A and 12 weeks for arm B.
Doel van het onderzoek
The hypothesis to be tested is that the outcome in arm B is better than in arm A.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Patients will be randomized between:
Arm A:
3 courses of standard CHOP q 3 weeks.
Arm B:
3 courses of intensified CHOP q 2 weeks plus G-CSF.
Patients with less than PR will go off protocol. Patients in PR or CR will proceed to another 5 courses of standard CHOP or another 3 courses of intensified CHOP plus G-CSF.
Publiek
Department of Hematology,
P.O. Box 85500
L.F. Verdonck
Utrecht 3508 GA
The Netherlands
+31 (0)30 2507230
l.f.verdonck@azu.nl
Wetenschappelijk
Department of Hematology,
P.O. Box 85500
L.F. Verdonck
Utrecht 3508 GA
The Netherlands
+31 (0)30 2507230
l.f.verdonck@azu.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Previously untreated patients with a primary NHL of intermediate- or high-grade malignancy according to the Working Formulation (group D,E,F,G,H);
2. Belonging to the intermediate risk group: stage II, LDH >=1.5x normal; stage III, LDH >1.5x normal; stage IV, LDH <1.5x normal;
3. Age >=15 <=65 years.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Patients with prior malignancies, except stage 1 cervix carcinoma and basocellular carcinoma;
2. Patients with severe cardiac (means severe heart failure requiring symptomatic treatment or a cardiac ejection fraction of < 45%) pulmonary, neurologic or metabolic disease- Inadequate liver or renal function, i.e. serum creatinine or bilirubin > 2.5x the upper normal value, except when related to the lymphoma;
3. HIV positivity;
4. Inability to give informed consent;
5. Involvement of the central nervous system by the NHL.
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 | NL202 |
| NTR-old | NTR239 |
| Ander register | : Ho26 |
| ISRCTN | ISRCTN11397785 |