Mantle cell lymphoma MedDRA version: 14.1 Level: LLT Classification code 10026799 Term: Mantle cell lymphoma NOS System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Mabthera
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Trade Name: Cytara
Sponsors
Nordic Lymphoma Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age 18-65 years. 2.Histologically confirmed (according to the WHO classification) mantle cell lymphoma stage II-IV at time of diagnosis. The diagnosis has to be confirmed by phenotypic expression of CD5, CD20 and cyclin D1 or the t(11;14) translocation. 3.High-risk patients defined by Mantle Cell Lymphoma International Prognostic Index Biological (MIPI) or MIPI Biological (MIPI-B) 4.No previous treatment for lymphoma except one cycle of any chemotherapy regimen. 5.WHO performance status of 0 – 2. 6.Life expectancy of more than 3 months. 7.Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1.Severe cardiac disease: NYHA grade 3-4. 2.Impaired liver-, renal-(GFR<50ml/min) or other organ function not caused by lymphoma, which will interfere with the treatment. 3.Pregnancy/lactation 4.Men or women of reproductive potential not agreeing to use acceptable method of birth control during treatment and for six moths after completion of treatment. 5.Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma. 6.Known seropositivity for HIV, HCV, HBsAg or other active infection uncontrolled by treatment. 7.Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study. 8. Treatment with any experimental compound within 30 days of start of MCL5 protocol treatment. 9. Patients with known allergies towards murine protiens. 10. Recent vaccination with live virus vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To increase the complete response rate pretransplant in aggressive mantle cell lymphoma by intensified immunochemotherapy with rituximab, high dose Ara-C and dexamethasone. In the Nordic area only high risk patients (MIPI-B or MIPI) are included. The result in all patients will be compared to a historic control of corresponding patients in the Nordic MCL2 trial.;Secondary Objective: Time to treatment failure Progression free survival Overall survival Toxicity Evaluation of response with FDG-PET Evaluation of response with MRD Stem cell harvest yield Evaluation of biomarkers for biology and prediction of response and response duration To establish a biobank ;Primary end point(s): Complete remission pretransplant;Timepoint(s) of evaluation of this end point: week 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Over all survival Time to treatment failure Time to progression Evaluation of response with FDG-PET and MRD Stem cell harvest yield Evaluation of biomarkers for biology and prediction of response and response duration ;Timepoint(s) of evaluation of this end point: Every 3 months for 2 years and then every 6 months to 5 years. FDG-PET evaluation week 15 and 3 months post transplant MRD evaluation Week 9 and 15 and 3, 6 months posttransplant and then every 6months to 5 years | — |
Countries
Denmark, Finland, Sweden
Contacts
Public ContactDept of Haematology L4042
Rigshospitalet
Outcome results
None listed