Intensive induction treatment with B-cell antibody (rituximab), chemotherapy (Ara-C) and steroids (dexamethasone or Bethamethasone) followed by high dose chemotherapy and autologous transplantation in aggressive mantle cell lymphoma patients 18-65 years.
- Conditions
- Mantle cell lymphomaMedDRA version: 14.1Level: LLTClassification code 10026799Term: Mantle cell lymphoma NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2011-001557-85-DK
- Lead Sponsor
- ordic Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method