MCL (WHO classification) Ann Arbor stage II ¨C IV CD20 positive
Conditions
Interventions
All registered patients will be treated with three courses of R-CHOP followed by two courses of HD Ara-C plus Rituximab. Patients with SD or PD (conventional criteria) after the second HD Ara-C course
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 7041560
Fax: 010 7041028
e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with histologically and immunologically proven diagnosis of MCL (WHO classification); 2. Ann Arbor stage II ¨C IV; 3. CD20 positive; 4. Age 18 - 65 years (inclusive); 5. WHO performance ¡Ü 2; 6. Measurable disease (also patients with isolated bone marrow disease are accepted) (appendix B); 7. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Renal failure (creatinine clearance < 50 ml/min); 2. Known hypersensitivity to murine antibodies, boron or mannitol; 3. Any other organ dysfunction or failure that may present a risk to the patient during any phase of protocol treatment; 4. Presence of CNS involvement by NHL; 5. Known HIV and hepatitis B or C seropositivity; 6. Pregnancy or lactation; 7. Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of (potential) organ dysfunction by localized lymphoma mass or infiltration; 8. Other active malignancy (less than 5 years in complete remission) except skin (non-melanoma) or cervix carcinoma stage 1; 9. Active systemic infection requiring treatment; 10. Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3; 11. Uncontrolled or severe cardiovascular disease, including MI within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis; 12. Serious medical condition (such as severe hepatic impairment, pericardial disease, acute diffuse pulmonary disease, systemic infections etc) or psychiatric illness likely to interfere with participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival (EFS). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Residual disease (quality of remission) as measured with FDG-PET, flow cytometry and molecular studies; 2. Toxicity of bortezomib maintenance therapy after high dose treatment; 3. Overall survival. | — |
Contacts
Public ContactJ.K. Doorduijn
Erasmus MC - Daniel den Hoed Afd. Hematologie Postbus 5201
Outcome results
None listed