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Clinical picture: CLL (Chronical Lymfatic Leukemia)

Trial: HOVON-associated Acerta CL-006


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


HOVON-associated Acerta CL-006 news

More information with regards to this study can be found on ClinicalTrials.gov:

Acerta006


1. Overview



Summary

ACE-CL-006: A Randomized, Multicenter, Open-Label, Non-inferiority, Phase 3 Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects with High Risk CLL


Status

open


Members

Open in:
Academisch Medisch Centrum Amsterdam (Amsterdam) Arnon Kater (.p.kater@amc.uva.nl)
Ikazia Ziekenhuis (Rotterdam) Francien Croon-de Boer (f.de.croon@ikazia.nl)
Flevoziekenhuis (Almere) Koen de Heer
Erasmus MC (Rotterdam) Jeanette Doorduijn (j.doorduijn@erasmusmc.nl)
Spaarne Ziekenhuis (Hoofddorp) Anita Griffioen-Keijzer
Kennemer Gasthuis (Haarlem) Inge Houtenbos
Albert Schweitzer Ziekenhuis (Dordrecht) Mark-David Levin (m-d.levin@asz.nl)
Universitair Medisch Centrum Utrecht (Utrecht)Rogier Mous (R.Mous@umcutrecht.nl)
Universitair Medisch Centrum Groningen (Groningen) Marcel Nijland (m.nijland@umcg.nl)
Reinier de Graaf Gasthuis (Delft) Ward Posthuma (E.Posthuma@rdgg.nl)
Gelre Ziekenhuizen (Apeldoorn) Cees Schaar
Tergooiziekenhuizen (Blaricum) Matthijs Silbermann (msilbermann@tergooi.nl)
Slotervaartziekenhuis (Amsterdam) Marcel Soesan
Gelre Ziekenhuizen (Zutphen) Leonie Strobbe
Wilhelmina Ziekenhuis (Assen) Janneke Swart-Heikens
MC Haaglanden (Den Haag) Liane te Boome (l.te.boome@mchaaglanden.nl)
Onze Lieve Vrouwe Gasthuis (Amsterdam) Wim Terpstra
Maxima Medisch Centrum (Veldhoven) Lidwine Tick (L.Tick@mmc.nl)
Amphia Ziekenhuis (Breda) Marjolein van der Klift (Mvanderklift@amphia.nl)
Maastricht University Medical Center (Maastricht)
Michel van Gelder (m.van.gelder@mumc.nl)
Orbis Medisch Centrum (Sittard) Roel van Kampen (r.vankampen@orbisconcern.nl)
Leids Universitair Medisch Centrum (Leiden)Hendrik Veelken (J.H.Veelken@lumc.nl)
Ziekenhuis Gelderse Vallei (Ede) Shulamit Wittebol
(WittebolS@zgv.nl)



Study details



2. Patient eligibility criteria



Inclusion criteria

Men and women ≥ 18 years of age.
ECOG performance status of 0 to 2.
Diagnosis of CLL.
Must have ≥ 1 of the following high-risk prognostic factors:
- Presence of 17p del by central laboratory.
- Presence of 11q del by central laboratory.
Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment
Must have received ≥ 1 prior therapies for CLL.
Measurable nodal disease by CT.
Meet the following laboratory parameters:
- ANC ≥ 750 cells/μL or ≥ 500 cells/μL in subjects with documented bone marrow involvement, and independent of growth factor support 7 days before assessment.
- Platelet count ≥ 30,000 cells/μL without transfusion support 7 days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded
- Serum AST/SGOT and ALT/SGPT < 3.0 x ULN.
- Total bilirubin ≤ 2.5 x ULN.
- Estimated creatinine clearance ≥ 30 mL/min.


Exclusion criteria

Known CNS lymphoma or leukemia.
Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.
Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura
Prior exposure to ibrutinib or to a BCR inhibitor or a BCL-2 inhibitor.
Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days before first dose of study drug.
Prior radio- or toxin-conjugated antibody therapy.
Prior allogeneic stem cell or autologous transplant.
Major surgery within 4 weeks before first dose of study drug.
Prior malignancy, except for adequately treated lentigo maligna melanoma, non-melanomatous skin cancer, in situ cervical carcinoma or other malignancy treated with no evidence of active disease > 3 years before Screening and at low risk for recurrence.
Currently active clinically significant cardiovascular disease within 6 months before first dose with study drug.
Known history of infection with HIV.
History of stroke or intracranial hemorrhage within 6 months before randomization.
History of bleeding diathesis.
Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 28 days of first dose of study drug.
Requires treatment with a strong CYP3A4 inhibitor/inducer.


3. Registration (& randomization) of patients



4. Participating parties



5. Participating sites



6. Instruction videos



7. Download documentation / forms




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