HOVON HO45

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Main info

Identificatie:
HOVON 45 MCL
Sponsor:
HOVON
Included patients:
88
Active sites:
15
(of 17)
Title:

High dose chemotherapy with cytoreduction and in vivo purging of the peripheral stem cell transplant by anti-CD20 (MabThera) in the treatment of mantle cell lymphoma.

Timeline

Scheduled
Actual
2001
15 mrt.
Activated
2004
15 nov.
ClosedForInclusionActualStart
2010
21 jul.
Archived

Flow

Flow

Details

Phase:
Prospective Phase II study
Monitoring Type:
Not any more
Objectives:

Eligibility

Inclusion Criteria:
  • Patients with histologically and immunologically proven mantle cell lymphoma (CD19+, CD5+, CD23-, Ig-light chain monoclonal, Cyclin-D1protein+)
  • Ann Arbor stage II - IV
  • CD20 positive
  • Age 18-65 years inclusive
  • WHO performance status 0 - 2
  • Written informed consent
Exclusion Criteria:
  • Prior treatment
  • Severe organ dysfunction not due to the lymphoma
  • Bilirubin > 2.5 x normal
  • Creatinine > 150 ��mol/l (not due to lymphoma)
  • History of active cancer during the past 5 years, except basal carcinoma of the skin or carcinoma in situ of the cervix
  • Uncontrolled infection
  • Central nervous system involvement of lymphoma
  • Pregnancy
  • HIV positivity

Participating Sites

Site
15 results
Order by
Accrual rate
Activation date
NL-Rotterdam-ERASMUSMC
17
NL-Nijmegen-RADBOUDUMC
15
NL-Groningen-UMCG
13
NL-Amsterdam-AMC
12
NL-Amsterdam-VUMC
10
NL-Den Haag-HAGA
7
NL-Zwolle-ISALA
4
NL-Rotterdam-EMCDANIEL
4
NL-Utrecht-UMCUTRECHT
1
NL-Utrecht-DIAKONESSENUTRECHT
1
NL-Nieuwegein-ANTONIUS
1
NL-Enschede-MST
1
NL-Amersfoort-MEANDERMC
1
NL-Leiden-LUMC
1
NL-Roosendaal-BRAVIS
= Active hospitals
= Inactive hospitals

Participating Parties

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