HOVON HO47

Archived

Main info

Identifier:
HOVON 47 NHL
Sponsor:
HOVON
Included patients:
15
Active sites:
0
(of 1)
13 sites are pending
Title:

Chlorambucil versus 2 x 2 Gy involved field radiotherapy in stage III/IV previously untreated follicular lymphoma patients. A prospective, randomized phase III clinical trial.

Timeline

Scheduled
Actual
2001
04 Oct
Activated
2014
04 Oct
Archived

Flow

Flow

Details

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

Eligibility

Inclusion Criteria:
  • Previously untreated Ann Arbor stage III and IV follicular lymphoma patients, grade I � III. (see appendices A and C)
  • Age 65 years or more, no upper limit.
  • WHO Performance Status 0 - 2. (see appendix E)
  • Nodal and extranodal sites, measurable bidimensionally on physical examination or diagnostic imaging.
  • Adequate haematological parameters at diagnosis: Hb >= 6.0 mmol/l, leukocytes >= 4.0 x 109 /l, thrombocytes >= 100 x 109 /l.
  • Written informed consent.
Exclusion Criteria:
  • Severe cardiac, pulmonary, neurologic, psychiatric or metabolic disease precluding either Chlorambucil chemotherapy or radiotherapy.
  • Patients with prior malignancies except basal cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Patients unable to fulfil regular outpatient appointments both for treatment and follow-up.
  • Known HIV-positivity.
  • Known central nervous system or orbital NHL localisation.
  • Use of systemic corticosteroid medication (inhalation and topical corticosteroids are allowed).

Participating Sites

Site
13 results
Order by
Accrual rate
Activation date
NL-Breda-AMPHIA
3
BE-Antwerpen-ZNAMIDDELHEIM
1
NL-Roermond-LZR
1
NL-Haarlem-SPAARNEHAARLEM
1
NL-Leidschendam-HMCANTONIUSHOVE
1
NL-Delft-RDGG
1
NL-Heerlen-ATRIUMMC
1
NL-Rotterdam-MAASSTADZIEKENHUIS
1
NL-Amsterdam-AVL
1
NL-Amsterdam-OLVG
1
NL-Leiden-LUMC
1
NL-Den Haag-HAGA
1
NL-Tilburg-VERBEETEN
1
= Active hospitals
= Inactive hospitals

Participating Parties

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