No registrations found.
ID
Source
Brief title
Health condition
Non Hodgkin’s Lymphoma.
Sponsors and support
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)
Intervention
Outcome measures
Primary outcome
CR rate and overall survival.
Secondary outcome
1. Disease-free survival;
2. Relapse rate;
3. Assessment of value of risk factors at diagnosis in relation to dose intensity of the treatment;
4. Morbidity, nr of days in hospital, treatment-related mortality, duration of leucopenia and other aspects in relation to dose intensity.
Background summary
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.
Study objective
The hypothesis to be tested is that the outcome in arm B is better than in arm A.
Study design
N/A
Intervention
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.
Department of Hematology,
P.O. Box 85500
L.F. Verdonck
Utrecht 3508 GA
The Netherlands
+31 (0)30 2507230
l.f.verdonck@azu.nl
Department of Hematology,
P.O. Box 85500
L.F. Verdonck
Utrecht 3508 GA
The Netherlands
+31 (0)30 2507230
l.f.verdonck@azu.nl
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL202 |
| NTR-old | NTR239 |
| Other | : Ho26 |
| ISRCTN | ISRCTN11397785 |