No registrations found.
ID
Source
Brief title
Health condition
MCL (WHO classification)
Ann Arbor stage II ¨C IV
CD20 positive
Sponsors and support
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
Intervention
Outcome measures
Primary outcome
Event free survival (EFS).
Secondary outcome
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.
Background summary
Study phase: II
Study objective:
Primary objective:To study the efficacy and toxicity of bortezomib maintenance after induction with HD Ara-C and stem cell transplantation.
Secondary objective:To study the value of FDG-PET, flow cytometry and IGVH–PCR for defining the quality of remission after induction with high dose chemotherapy and Rituximab, after auto PSCT and during maintenance treatment with bortezomib, in comparison to conventional definitions.
Patient population:
Patients with newly diagnosed mantle cell lymphoma who reached PR or CR after chemotherapy combined with rituximab and high dose treatment followed by autologous stem cell transplantation.
Study design:
Prospective, multicenter, phase II.
Duration of treatment:
Expected duration of induction, intensification and BEAM with Auto PSCT is 7 months. Maintenance therapy with bortezomib will be given for 2 years.
Study objective
The objective of this phase II study is to determine whether there is an indication that bortezomib maintenance might result in a better event free survival.
Study design
1. Event Free Survival: Hazard ratio and difference in 2 year EFS with 95% confidence intervals;
2. Overall Survival: Hazard ratio and difference in 2 year OS with 95% confidence intervals;
3. Development of quantifiable residual disease, as assessed by FDG-PET, flow cytometry and molecular studies during bortezomib maintenance in comparison without further treatment.
Intervention
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 will go off study. Patients in CR or PR will continue with an autologous stem cell transplantation after BEAM conditioning. After this, patients will be randomized for treatment with bortezomib maintenance therapy or no further treatment, unless there is progression or relapse.
Afd. Hematologie
Postbus 5201
J.K. Doorduijn
Rotterdam 3008 AE
The Netherlands
010 7041598
j.doorduijn@erasmusmc.nl
Afd. Hematologie
Postbus 5201
J.K. Doorduijn
Rotterdam 3008 AE
The Netherlands
010 7041598
j.doorduijn@erasmusmc.nl
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
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
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 | NL1671 |
| NTR-old | NTR1772 |
| Other | METC Erasmus MC : 2006-086 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |