Intensive induction treatment with B-cell antibody (rituximab), chemotherapy (Ara-C) and steroids (dexamethasone) followed by high dose chemotherapy and autologous transplantation in aggressive mantle cell lymphoma patients younger than 66 years.
- Conditions
- Mantle cell lymphomaMedDRA version: 13.1Level: LLTClassification code 10026799Term: Mantle cell lymphoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2011-001557-85-SE
- Lead Sponsor
- ordic Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
1.Age <66 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.Nordic countries: high-risk patients defined by Mantle Cell Lymphoma International Prognostic Index Biological (MIPI-B), in UK all patients in need of treatment.
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) are included, while in the UK all pteints in need of treatment 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<br>Progression free survival<br>Overall survival<br>Toxicity<br>Evaluation of response with FDG-PET<br>Evaluation of response with MRD<br>Stem cell harvest yield<br>Evaluation of biomarkers for biology and prediction of response and response duration<br>To establish a biobank <br><br> ;Primary end point(s): Complete remission pretransplant;Timepoint(s) of evaluation of this end point: week 15
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Over all survival<br>Time to treatment failure<br>Time to progression<br>Evaluation of response with FDG-PET and MRD<br>Stem cell harvest yield<br>Evaluation of biomarkers for biology and prediction of response and response duration<br>;Timepoint(s) of evaluation of this end point: Every 3 months for 2 years and then every 6 months to 5 years.<br>FDG-PET evaluation week 15 and 3 months post transplant<br>MRD evaluation Week 9 and 15 and 3, 6 months posttransplant and then every 6months to 5 years