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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 35 NHL / EORTC 20963


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

Marrow-Ablative Chemo-Radiotherapy and Autologous Stem Cell Transplantation followed by Interferon-Alpha Maintenance Treatment versus Interferon-Alpha Maintenance Treatment alone after a Chemotherapy-Induced Remission in Patients with Stages III or IV Follicular Non-Hodgkin�s Lymphoma: A Prospective, Randomized, Phase III Clinical Trial - Intergroup collaborative study (EORTC 20963).


Status

closed


Members

Hovon 35 is an Intergroup Study, with the following centers participating: EORTC, BNLI(UK), HOVON



Study details



Type of study

Prospective randomized Phase III study


Target number of patients

469


Date of activation

04-Apr-1997


Date closed

05-Apr-1999


Change history / amendement

HOVON 35 was closed on account of there only having been 30 randomised patients in two-and-a-half years.


2. Patient eligibility criteria



Inclusion criteria

Previously untreated patients with follicular NHL presenting with stages III or IV, including nodal, Waldeyer�s ring and extranodal localisations.
Follicular NHL according to the: - REAL classification (follicle center lymphoma, follicular provisional cytologic grades: I, II, III) - International Working Formulation (Groups B, C, D) - Kiel Classification (malignant lymphoma)
Age above 18 years and below 66 years.
WHO performance Status grade 0, 1 or 2.
Patient information and informed consent according to the rules of the respective country.


Exclusion criteria

Patients with severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease.
Serum creatinine, BUN, alkaline phoshatase or bilirubin: = 2.5 times the upper limit of the normal value, unless clearly related to NHL.
Pregnant women.
Patients with prior malignancies except non-melanoma skin tumors or stage 0 cervical carcinoma.
Patients with HIV positivity.
Patients who are unable to attend regular outpatient appointments for treatment and treatment evaluation.


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�s name/number
Patients�s identification: - initials - date of birth - sex - optional: hospital record number
Checklist of inclusion/exclusion criteria
Date of last course CVP
Response to CVP
�Immediate treatment� or �wait and see� policy
Projected date of treatment start
Name of investigator and location of trial center


4. Participating parties



Principal investigator

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


Coordinating investigator(s)

R Marcus


Statistician(s)

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


Trial manager

MMC Steijaert (steijaert@stah.azr.nl)


Central data management

HOVON Data Manager:
MMC Steijaert (steijaert@stah.azr.nl)
EORTC Data Manager:
I Teodorovic (E-mail Address: ite@eortc.be)


Other functions

EORTC Statistician:
M van Glabbeke

Please contact monitors at hdcmonitorteam@erasmusmc.nl


5. Participating sites



6. Instruction videos



7. Download documentation / forms




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