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Clinical picture: Benign

Trial: HOVON 64 ITP


News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


HO64 news

Closure of the HOVON 64 ITP study

At this moment 156 patients have been included in the HOVON 64 ITP study.

As agreed, the study will be closed as soon as the 156th patient is included.

This means that you wil not be able to include any more ITP patients into the HOVON 64 ITP study, from this moment. We thank you for participating in this trial.

 


1. Overview



Summary

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


Status

closed



Study details



Type of study

Prospective randomized Phase II study


Target number of patients

150


Date of activation

29-Aug-2005


Approved by

METC AMC, June 9, 2005;
amendment 1: May 16, 2006;
amendment 2: January 29, 2008


Change history / amendement

Amendment 2 is active


Study 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.


2. Patient eligibility criteria



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.


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



Protocol number
Institution name
Name of caller/responsible investigator
Patients initials or code
Sex
Date of birth
Patients hospital record number
WHO performance status
Date of ITP diagnosis
Eligibility criteria
Splenectomy status


4. Participating parties



Principal investigator

J.J. Zwaginga (j.j.zwaginga@lumc.nl)


Coordinating investigator(s)

H.R. Koene
G. Vreugdenhil
P.C. Huijgens
B. Biemond


Statistician(s)

B. van der Holt (b.vanderholt@erasmusmc.nl)


Trial manager

M. Luten (m.luten@erasmusmc.nl)


Central data management

R. Hollestein (r.hollestein@erasmusmc.nl)


Other functions

Central Laboratory Analysis (Sanquin Research)
M. de Haas (m.dehaas@sanquin.nl)
L. Porcelijn (l.porcelijn@sanquin.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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