HOVON HO64

Archived

Main info

Identifier:
HOVON 64 ITP
Sponsor:
HOVON
Included patients:
156
Active sites:
34
(of 35)
Title:

Anti-CD20 treatment of relapsed or refractory Immune Thrombocytopenic Purpura (ITP) after first line corticosteroid treatment.

Timeline

Scheduled
Actual
2005
29 Aug
Activated
2020
23 Oct
Archived

Flow

Flow

Details

Phase:
Prospective randomized Phase II study
Monitoring Type:
Objectives:
  • The main objective of the current study is to investigate the effectiveness of three different dosing schedules rituximab in refractory or relapsed ITP patients, whether or not already splenectomized.
  • Furthermore, stratification for splenectomy will be performed to reliably assess whether treatment of non-splenectomized patients with rituximab results in avoidance of splenectomy after 1 year follow up.

Eligibility

Inclusion Criteria:
  • Age minimal 18 years
  • Subjects with relapsed or refractory ITP (fulfilling the diagnostic criteria given in appendix A) and platelet numbers <30 x 10^9/l
  • Having completed first line treatment with corticosteroids
  • Written informed consent
  • WHO performance status <= 2
Exclusion Criteria:
  • The presence of an accessory spleen in splenectomized patients.
  • Use of anticoagulants or chemotherapy or known other disorders and/or treatments influencing the platelet number within 3 months of randomization date (tranexaminic acid (Cyklokapron) treatment is allowed).
  • Pulsed or high dose corticosteroids, IVIG or splenectomy within 3 weeks prior to randomization. Maintenance corticosteroid therapy is allowed.
  • Prior therapy with rituximab.
  • ITP treatments (other than corticosteroids, IVIG or splenectomy) within 3 months prior to randomization (e.g. cyclosporine, vincristine). Stable treatment with non-immunosuppressive medication (i.e. danazol, dapson, vitamin C) is permitted.
  • Inadequate renal and liver function, i.e. creatinin or bilirubin >2.5 x the upper normal value
  • Neutrophil count <1.5 x 10^9/l and hemoglobin level <6.2 mmol/l.
  • Active bleeding (defined by grade 3 or 4 according to NCI CTCAE v3.0)
  • Pregnant or lactating
  • Systemic infections: active viral infections, including HIV
  • Seriously immunocompromised patients
  • Systemic autoimmune disorders (e.g. Systemic lupus erythematosus (SLE))
  • Current malignant disease
  • Any experimental therapy within 30 days prior to randomization.

Participating Sites

Site
34 results
Order by
Accrual rate
Activation date
NL-Rotterdam-ERASMUSMC
29
NL-Amsterdam-AMC
17
NL-Dordrecht-ASZ
12
NL-Utrecht-DIAKONESSENUTRECHT
9
NL-Leiden-LUMC
8
NL-Den Bosch-JBZ
7
NL-Maastricht-MUMC
7
NL-Amsterdam-VUMC
7
NL-Nieuwegein-ANTONIUS
6
NL-Enschede-MST
6
NL-Amersfoort-MEANDERMC
6
NL-Nijmegen-RADBOUDUMC
5
NL-Eindhoven-MAXIMAMC
5
NL-Den Haag-HAGA
5
NL-Hoorn-DIJKLANDERHOORN
5
NL-Hilversum-TERGOOI
4
NL-Hoofddorp-SPAARNEGASTHUIS
3
NL-Ede-ZGV
3
NL-Purmerend-DIJKLANDERPURMEREND
2
NL-Heerlen-ATRIUMMC
2
NL-Roosendaal-BRAVIS
2
NL-Amsterdam-OLVG
1
NL-Winterswijk-SKBWINTERSWIJK
1
NL-Rotterdam-MAASSTADZIEKENHUIS
1
NL-Amsterdam-SLOTERVAART
1
NL-Lelystad-STJANSDALLELYSTAD
NL-Sittard-Geleen-ZUYDERLAND
NL-Beverwijk-RKZ
NL-Alkmaar-NWZ
NL-Dirksland-VANWEELBETHESDA
NL-Almere-FLEVOZIEKENHUIS
NL-Goes-ADRZ
NL-Amstelveen-AMSTELLAND
NL-Amsterdam-SLAZANDREAS
= Active hospitals
= Inactive hospitals

Participating Parties

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