HOVON HO69

Archived

Main info

Identifier:
HOVON 69 T-NHL
Sponsor:
HOVON
Included patients:
20
Active sites:
19
(of 19)
Title:

A phase II study of anti-CD52 monoclonal antibody (Alemtuzumab, MabCampath) with 2-weekly CHOP chemotherapy (Camp-CHOP 14) in patients with mature T-cell non-Hodgkin's lymphoma.

Timeline

Scheduled
Actual
2005
16 Nov
Activated
2007
01 Nov
CloseoutInProgressLastPtOutActualStart
2017
01 Nov
Archived

Flow

Flow

Details

Phase:
Prospective Phase II study
Monitoring Type:
Objectives:

Eligibility

Inclusion Criteria:
  • Patients with a confirmed histologic diagnosis of T-NHL according to the WHO classification:

a. Extranodal NK/T cell lymphoma, nasal type;
b. Enteropathy-type T-cell lymphoma (EATL), if measurable disease;
c. Subcutaneous panniculitis-like T-NHL;
d. Angioimmunoblastic T-cell lymphoma;
e. Peripheral T-cell lymphoma, unspecified (T-NHL NOS);

  • Age 18-65 years inclusive;
  • Ann Arbor stage II or more;
  • WHO performance status 0, 1 or 2;
  • Measurable disease;
  • Written informed consent
Exclusion Criteria:
  • Patients with NK/T-NHL of the following type:

a. Precursor T cell lymphoblastic lymphoma/leukemia;
b. All mature T cell leukemias (T-PLL, ATLL, NK cell leukemia, T-LGL);
c. Anaplastic large cell lymphoma;
d. Hepatosplenic T cell lymphoma;
e. Enteropathy-type T cell lymphoma without measurable disease;
f. Blastic NK cell lymphoma;

  • Intolerance of exogenous protein administration;
  • Severe cardiac dysfunction (NYHA classification II-IV) or LVEF < 45 %;
  • Significant renal dysfunction (serum creatinine >= 150 mmol/l), unless related to NHL;
  • Significant hepatic dysfunction (total bilirubin >= 30 mmol/l or transaminases >= 2.5 times normal level), unless related to NHL;
  • Suspected or documented Central Nervous System involvement by NHL;
  • Patients known to be HIV-positive;
  • Patients with active, uncontrolled infections;
  • Patients with uncontrolled asthma or allergy, requiring steroid treatment;
  • Prior treatment with chemotherapy, radiotherapy or immunotherapy for this lymphoma, except local radiotherapy in case of (potential) organ dysfunction by localized lymphoma mass or infiltration;
  • History of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma;

Participating Sites

Site
19 results
Order by
Accrual rate
Activation date
NL-Zwolle-ISALA
5
NL-Groningen-UMCG
4
NL-Rotterdam-ERASMUSMC
3
NL-Den Haag-HAGA
2
NL-Amsterdam-AMC
1
NL-Nieuwegein-ANTONIUS
1
NL-Maastricht-MUMC
1
NL-Leiden-LUMC
1
NL-Roosendaal-BRAVIS
1
NL-Amsterdam-VUMC
1
NL-Leeuwarden-MCL
NL-Amstelveen-AMSTELLAND
NL-Amsterdam-AVL
NL-Utrecht-UMCUTRECHT
NL-Amsterdam-OLVG
NL-Enschede-MST
NL-Amersfoort-MEANDERMC
NL-Rotterdam-EMCDANIEL
NL-Utrecht-DIAKONESSENUTRECHT
= Active hospitals
= Inactive hospitals

Participating Parties

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