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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 27 NHL 94


News
1. Overview
Study details
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


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1. Overview



Summary

Triple High-Dose Chemotherapy with Autologous Stem Cell Support as First Line Treatment for High-Risk Non Hodgkin?s Lymphoma: A Phase II Study.


Status

closed



Study details



Type of study

Prospective Phase II study


Target number of patients

50


Date of activation

15-Jan-1996


Approved by

CKVO November 1995 Approved
NKB-CKVO 94-13


2. Patient eligibility criteria



Inclusion criteria

Biopsy proven NHL of high or intermediate histology according to the Working Formulation.
No prior treatment.
Belonging to the high risk group.
Ages between 15 and 65 years.


Exclusion criteria

HIV positivity.
Prior malignancy, except skin (non-melanoma) or cervix carcinoma stage I.
Severe major organ dysfunction or metabolic disease.
Inadequate liver or renal function, unless due to NHL.
WHO performance > 2.
Inability to give informed consent.
CNS involvement of NHL.
Acute lymphoblastic leukemia.
WF groups I,J, stage I non-bulky and LDH < 1.5 x normal.


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:



Name institute
Name caller/physician who treats the patient
(coded) initials of patient
Hospital record number
Sex
Date of birth
Pathological diagnosis
Stage
LDH


4. Participating parties



Principal investigator

GW van Imhoff (g.w.vanimhoff@int.azg.nl)


Coordinating investigator(s)

LF Verdonck (l.f.verdonck@digd.azu.nl)


Statistician(s)

W.L.J. van Putten (w.vanputten@erasmusmc.nl)
B. van der Holt (b.vanderholt@erasmusmc.nl)


Trial manager

M van os (os@stah.azr.nl)


Central data management

M van os (os@stah.azr.nl)


Other functions

Central Pathologist:
S Poppema

Please contact monitors at hdcmonitorteam@erasmusmc.nl


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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