Zevalin-BEAM/BEAC With Autologous Stem Cell Support as Consolidation in First Line Treatment of Mantle Cell Lymphoma

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine if outcome for patients with mantle cell lymphoma is improved by adding radioimmunotherapy to high-dose regimen before auto-transplant in patients who are not in CR after induction therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion criteria:

1. Age 18 - 65 years.

2. Histologically confirmed (according to the WHO classification) mantle cell lymphoma stage II-IV at time point of diagnosis. The diagnosis has to be confirmed by phenotypic expression of CD5, CD20 and cyclin-D1 and most cases will have t(11;14) translocation.

3. No previous treatment for lymphoma except radiotherapy or one cycle of any regimen and except patients treated in the previous phase II study who can be transferred to NLG-MCL-III before evaluation at week 15.

4. WHO performance status of 0 - 3.

5. Life expectancy of more than 3 months.

6. Written informed consent.

Exclusion Criteria:

1. Severe cardiac disease: cardiac function grade 3-4 (Appendix 1).

2. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment.

3. Pregnancy/lactation

4. Men or woman of reproductive potential not agreeing to use acceptable method of birth control during treatment and for six moths after completion of treatment.

5. Known HIV positivity

6. Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma.

7. Known seropositivity for HCV, HbsAg or other active infection uncontrolled by treatment.

8. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.