Transcript Studies open voor inclusie

Studies open voor inclusie – Afdeling Hematologie
Acute Lymfatische Leukemie
Externe code
HOVON100
Titel
Onderzoeker
Clofarabine added to prephase and consolidation therapy in acute lymphoblastic
Velden, van der
leukemia in adults
W.J.F.M.
Acute Myeloïde Leukemie
Externe code
Titel
Onderzoeker
Randomized study with a run-in dose-selection phase to assess the added value
of lenalidomide in combination with standard remission-induction chemotherapy
HOVON132
and post-remission treatment in patients aged 18-65 years with previously
untreated acute myeloid leukemia (AML) or high risk myelodysplasia (MDS)
Velden, van der
W.J.F.M.
(IPSS-R risk score > 4.5)
A program of randomized phase II multicenter studies to assess the tolerability
HOVON135
and efficacy of the addition of new drugs to 10-day decitabine in unfit (i.e.HCT-
Velden, van der
CI>=3) AML and high risk myelodysplasia (MDS)(IPSS-R>4.5) patients aged >=
W.J.F.M.
66 years
InDACtion vs. induction: 10-day decitabine versus conventional chemotherapy
EORTC1301 -
(3+7) followed by allografting in AML patients ≥ 60 years: a randomized phase III
Velden, van der
AML21
study of the EORTC Leukemia Group, CELG, GIMEMA and German MDS Study
W.J.F.M.
Group
PLMA34
10-day decitabine, fludarabine and 2 gray TBI as conditioning strategy for poor
Velden, van der
and very poor risk AML in CR1
W.J.F.M.
A randomized, open label, phase 2 study of the selective inhibitor of nuclear
SOPRA
export (SINE) selinexor (KPT-330) versus specified physician's choice in
Velden, van der
KCP-330-008
patients ≥ 60 years old with relapsed/refractory acute myeloid leukemia (AML)
W.J.F.M.
who are ineligible for intensive chemotherapy and/or transplantation
Studies open voor inclusie – Afdeling Hematologie – Radboudumc
Oktober 2016
1
Chronische Myeloïde Leukemie
Externe code
Titel
Bosutinib
A retrospective observational research study to describe the real world use of
registry
bosutinib in the UK and Netherlands B1871052
Onderzoeker
Blijlevens, N.M.A.
MDS
Externe code
EU-MDS NL
Titel
Onderzoeker
A prospective, multicenter European registry for newly diagnosed patients with
Langemeijer,
myelodysplastic syndromes of IPSS low and intermediate-1 subtypes
S.M.C.
A phase 3, multicenter, randomized, double-blind study to compare the efficacy
AZA-MDS-003
and safety of oral azacitidine plus best supportive care versus placebo plus best
Langemeijer,
supportive care in subjects with red blood cell transfusion-dependent anemia
S.M.C.
and thrombocytopenia due to IPSS lower-risk myelodysplastic syndromes
IMerge
MDS3001
INCLUSION
ON HOLD
A study to evaluate imetelstat (JNJ-63935937) in transfusion-dependent subjects
with IPSS low or intermediate-1 risk myelodysplastic syndrome (MDS) that is
relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment
Langemeijer,
S.M.C.
Lymfomen
Externe code
Titel
Onderzoeker
Efficacy of alternating immunochemotherapy consisting of R-CHOP + RHAD
HOVON 119
versus R-CHOP alone, followed by maintenance therapy consisting of additional
lenalidomide with rituximab versus rituximab alone for older patients with mantle
Stevens, W.B.C.
cell lymphoma
HOVON127
HOVON 900
Phase III study comparing R-CODOX-M/R-IVAC versus dose-adjusted EPOCHR (DA-EPOCH-R) for patients with newly diagnosed high risk Burkitt lymphoma
A national MYC screening study in relation to the HOVON 130 protocol
Studies open voor inclusie – Afdeling Hematologie – Radboudumc
Oktober 2016
Stevens, W.B.C.
Stevens, W.B.C.
2
Multipel Myeloom
Externe code
Titel
Onderzoeker
Pomalidomide combined with carfilzomib and dexamethasone (PCd) for
induction and consolidation followed by pomalidomide combined with
HOVON 114
dexamethasone vs pomalidomide maintenance for patients with multiple
Croockewit, A.J.
st
myeloma in first relapse after prior 1 line treatment with lenalidomide and
bortezomib
Study of daratumumab (JNJ-54767414 (Humax CD38)) in combination with
HOVON 131
velcade, thalidomide and dexamethasone (VTD) in the first line treatment of
Croockewit A.J.
transplant eligible subjects with newly diagnosed Multiple Myeloma
A phase II, open-label, study in subjects with BRAF V600E mutated rare
BRF117019
cancers with several histologies to investigate the clinical efficacy and safety of
Croockewit, A.J.
the combination therapy of dabrafenib and trametinib
Myeloproliferatieve ziekten
Externe code
Titel
Onderzoeker
A phase 2, prospective study of PRM-151 in subjects with primary myelofibrosis
PRM-151G-101
(PMF), post-polycythemia vera MF (post-PV MF), or post-essential
Schaap, N.P.M.
thrombocythemia MF (post-ET MF)
Stamceltransplantatie
Externe code
Titel
Onderzoeker
Vaccination with PD-L1/L2-silenced minor histocompatibility antigen-loaded
PSCT19
donor DC vaccines to boost graft-versus-tumor immunity after allogeneic stem
Schaap, N.P.M.
cell transplantation (a phase I/II study)
Supportive Care
Externe code
ORASTEM
Titel
Oral complications in patients treated with hematopoietic stem cell
transplantation
Studies open voor inclusie – Afdeling Hematologie – Radboudumc
Oktober 2016
Onderzoeker
Blijlevens, N.M.A.
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SC29
Enteral versus parenteral nutrition in adult stem cell transplantation patients with
chemotherapy-induced gastro-intestinal mucositis
Blijlevens, N.M.A.
Stolling
Externe code
Titel
Onderzoeker
PRO-RBDD
Prospective data collection on patients with rare bleeding disorders
Laros, B.A.P.
Multicenter, open-label, parallel-arm, multiple-dose study to investigate
CSL689_1002
pharmacokinetics, efficacy and safety of rVIIa-FP (CSL689) in subjects with
Laros, B.A.P.
congenital factor VII deficiency
OPTI-CLOT
Peri-operative pharmacokinetic-guided dosing of clotting factor in hemophilia
Laros, B.A.P.
EUHASS
European haemophilia safety surveillance system registry
Laros, B.A.P.
A phase 1, prospective, open label, two periode, fixed sequence, doseBAX826
escalation study of the PK and safety of BAX826 (PSA-rFVIII) in previously
Laros, B.A.P.
treated patients with severe (FVIII<1%) haemophilia A
PNH
Externe code
Titel
RPNH01
Paroxysmal nocturnal hemoglobinuria (PNH) registry
AK study 578
Onderzoeker
Langemeijer,
S.M.C.
Coversin in paroxysmal nocturnal haemoglobinuria (PNH) in patients with
Langemeijer,
resistance to eculizumab due to complement C5 polymorphisms
S.M.C.
Indien u nadere informatie wenst over een studie van afdeling Hematologie, dan kunt u contact
opnemen met het Trialbureau Hematologie – Oncologie, bereikbaar via telefoonnummer 024 –
3614794 en/of e-mail [email protected].
Studies open voor inclusie – Afdeling Hematologie – Radboudumc
Oktober 2016
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