| Source of record | UK Co-ordinating Committee on Cancer Research (UKCCCR) |
| Serial number at source | EBMT LYM1 |
| Title of trial | A Randomised Study of Rituximab (Mabthera) in patients with Relapsed or Resistant Follicular Lymphoma prior to High Dose Therapy as In Vivo purging and to maintain remission following high dose therapy. |
| Disease or condition | Lymphoma (non-Hodgkin's) |
| Current status of trial | Open |
| Objectives | 1. To evaluate the effects of in vivo purging with rituximab and maintenance rituximab on time to disease progression in patients with relapsed follicular NHL undergoing high dose therapy.
2. To evaluate the effects of in vivo purging with rituximab and maintenance rituximab on response rate and overall survival in patients with relapsed or resistant follicular lymphoma undergoing high dose therapy
3. To evaluate the effect of in vivo purging with rituximab on molecular remission rates in the haemopoetic product and the patients
4. To evaluate the safety of rituximab in the transplant setting. |
| Eligibility criteria | 1. Relapsed or resistant follicular lymphoma.
2. CD20 positive with no evidence of transformation. Previous treatment with anti-CD20 antibody (MabThera) is permitted if given >12 months prior to study randomisation.
3. Achievement of CR or VGPR following re-induction chemotherapy (any standard regimen acceptable). Including patients failing to respond to first line chemotherapy who proceed directly to second line chemotherapy (induction) and consequently acheive CR/VGPR.
4. 18 years of age or older.
5. Adequate bone marrow function: platelets>100x10(9)/L
6. WHO performance status 0 or 1
7. Pathological material must be available for central review and PCR analysis of t(14:18).
8. Patient information and written consent according to the rules of the respective centre. |
| Sample size | Current accrual: 126 |
| Randomised interventions | All patients receive a stem cell transplant.
Group 1: Receive Mabthera purging prior to transplant and maintenance Mabthera
Group 2: Receive Mabthera purging before transplant but no maintenance Mabthera
Group 3. Receive no Mabthera purging prior to transplant but receive maintenance Mabthera after transplant.
Group 4. No Mabthera purging and no maintenance Mabthera after transplant (Control group). |
| 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 |
