| Source of record | UK Co-ordinating Committee on Cancer Research (UKCCCR) |
| ISRCTN | ISRCTN65655917 |
| Serial number at source | EORTC 20981 |
| Title of trial | Chimeric anti-CD20 monoclonal antibody (Mabthera) in remission induction and maintenance treatment of relapsed follicular non-Hodgkin's lymphoma - a phase III randomised clinical trial (Intergroup Collaborative Study). |
| Disease or condition | Lymphoma (non-Hodgkin's) |
| Current status of trial | Open |
| Objectives | To establish in a prospective randomised clinical trial the effect of addition of chimeric anti-CD20 monoclonal antibody to CHOP chemotherapy on the response rate and quality (partial remission, complete remission, molecular complete remission) in relapsed low-grade non-Hodgkin's Lymphoma.
To establish in a prospective randomised clinical trials the effect of maintenance treatment with chimeric anti-CD20 monoclonal antibody on progression free survival in relapsed low grade non-Hodgkin's lymphoma in remission after CHOP+/- Mabthera. |
| Eligibility criteria | 1. Patients with Ann Arbour stages III or IV follicular NHL (at initial diagnosis) who have relapsed after a minimum of two adequate non-anthracycline containing systemic chemotherapy regimens. Patients pre-treated with other chemotherapy regimens are not eligible for this trial.
2. Patients should have achieved remission on at least one of the prior regimens (i.e. either on the first or second regimen).
3. Remission duration upon one of the prior regimens should have been at least 3 months.
4. Previous treatment should have been at least 4 month of single agent therapy (e.g. chlorambucil) and/or at least 4 consecutive cycles of polychemotherapy (e.g. CVP) or purine analogues. Patients treated with chemotherapy not fulfilling these criteria are not eligible.
5. Follicular NHL according to the REAL classification (19) i.e. follicle centre lymphoma, follicular (provisional cytological grades I(small cell) II (mixed small cell and large cell) III (large cell)).
6. Must be CD20 positive lymphoma
7. At least one mass should be present measurable by 2 perpendicular diameters by either physical or radiological examination.
8. Aged 18 years or above.
9. WHO performance status 0,1 or 2
10. Patient information and written informed consent according to the rules of the respective country. |
| Sample size | Current accrual: 266 |
| Randomised interventions | Arm 1: CHOP will be given at 3-week intervals. After 3 cycles patients will be evaluated for response. Patients with stable or progressive disease will go off study. A total of 6 cycles will be given.
Arm 2: CHOP plus Mabthera. Mabthera (iv) given on first day of each cycle of CHOP. Stable or progressive patients after 3 cycles will go off the study. A total of 6 cycles will be given. |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
LONDON NW1 2DA
Tel: +44 (0) 20 7670 4723
Fax: +44 (0) 20 7670 4818
|
| Further information | Further information about this trial may be obtained from UKCCCR Register's own website, which contains full trial reports. |
| General information | Please visit the UKCCCR Register website for further general information. |
| Date live in mRCT | 01 April 2007 |
