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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 45 MCL


News
1. Overview
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


No news


1. Overview



Summary

High dose chemotherapy with cytoreduction and in vivo purging of the peripheral stem cell transplant by anti-CD20 (MabThera) in the treatment of mantle cell lymphoma


Status

closed



Type of study

Prospective Phase II study


Target number of patients

40


Date of activation

15-Mar-2001


Approved by

CKTO: CKTO 2000-04, 5 October 2000
MEC: METc EUR/AZR, 23 January 2001


2. Patient eligibility criteria



Inclusion criteria

Patients with histologically and immunologically proven mantle cell lymphoma (CD19+, CD5+, CD23-, Ig-light chain monoclonal, Cyclin-D1protein+)
Ann Arbor stage II - IV
CD20 positive
Age 18-65 years inclusive
WHO performance status 0 - 2
Written informed consent


Exclusion criteria

Prior treatment
Severe organ dysfunction not due to the lymphoma
Bilirubin > 2.5 x normal
Creatinine > 150 ƒİmol/l (not due to lymphoma)
History of active cancer during the past 5 years, except basal carcinoma of the skin or carcinoma in situ of the cervix
Uncontrolled infection
Central nervous system involvement of lymphoma
Pregnancy
HIV positivity


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



Protocol number
Institution name
Name of caller/responsible investigator
Patient's initials or code
Patient's hospital record number
Sex
Date of birth
Date of diagnosis of mantle cell lymphoma
Eligibility criteria


4. Participating parties



Principal investigator

M.B. van 't Veer (Veer@hemh.azr.nl)


Coordinating investigator(s)

A. Hagenbeek (a.hagenbeek@lab.azu.nl)


Statistician(s)

W.L.J. van Putten (w.vanputten@erasmusmc.nl)


Trial manager

P. Cornelisse (p.cornelisse@erasmusmc.nl)


Central data management

P. Cornelisse (p.cornelisse@erasmusmc.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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