HOVON HO35 NHL

Gearchiveerd

Main info

Identificatie:
HO35 NHL / EORTC 20963
Sponsor:
HOVON
Included patients:
65
Active sites:
0
(of 27)
27 sites are pending
Title:

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).

Timeline

Scheduled
Actual
1997
27 feb.
Activated
1999
05 apr.
ClosedForInclusionActualStart
2009
05 apr.
Archived

Flow

Flow

Details

Phase:
Prospective randomized Phase III study
Monitoring Type:
Objectives:

Eligibility

Inclusion Criteria:
  • Previously untreated patients with follicular NHL presenting with stages III or IV, including nodal, Waldeye'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.

Participating Sites

Site
27 results
Order by
Accrual rate
Activation date
NL-Nijmegen-RADBOUDUMC
8
NL-Rotterdam-ERASMUSMC
8
NL-Amersfoort-MEANDERMC
7
NL-Rotterdam-EMCDANIEL
5
BE-Leuven-UZLEUVEN
4
NL-Enschede-MST
4
NL-Zwolle-ISALA
4
NL-Groningen-UMCG
3
NL-Delft-RDGG
2
NL-Amsterdam-AMC
2
NL-Roosendaal-BRAVIS
2
NL-Sittard-Geleen-ZUYDERLAND
1
NL-Goes-ADRZ
1
NL-Hilversum-TERGOOI
1
NL-Tilburg-TWEESTEDEN
1
NL-Rotterdam-IKAZIA
1
NL-Spijkenisse-SPIJKENISSEMC
1
NL-Dirksland-VANWEELBETHESDA
1
NL-Amsterdam-SLAZLUCAS
1
NL-Heerlen-ATRIUMMC
1
NL-Schiedam-FRANCISCUSVLIETLAND
1
NL-Rotterdam-MAASSTADZIEKENHUIS
1
NL-Utrecht-UMCUTRECHT
1
NL-Nieuwegein-ANTONIUS
1
NL-Eindhoven-MAXIMAMC
1
NL-Den Bosch-JBZ
1
NL-Vlaardingen-VLIETLANDVLARDINGEN
1
= Active hospitals
= Inactive hospitals

Participating Parties

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