Mid-term report 2013 - The European LeukemiaNet
Mid-term report 2013 - The European LeukemiaNet
Mid-term report 2013 - The European LeukemiaNet
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<strong>European</strong> <strong>LeukemiaNet</strong> <strong>Mid</strong><strong>term</strong> Report, 08-RNP-071<br />
7.4. Appendix IV – <strong>European</strong> added value and ELN visibility<br />
7.4.1. New trials in the ELTR<br />
UKALL 14<br />
MARALL<br />
AMLSG 16-10<br />
EuroSKI<br />
HOMB 114242<br />
ARD12042<br />
BUM-5/GVH<br />
C AMN107 Y 2101<br />
JAKARTA<br />
HCT vs CT<br />
B1931022<br />
ARCADE<br />
ENESTFreedom<br />
EPIC<br />
RELIEF<br />
I3X-MC-JHTB<br />
JAKARTA2<br />
PIRON01<br />
OCEAN<br />
A Randomized Trial for Adults With Newly Diagnosed Acute Lymphoblastic Leukemia<br />
Phase I/II study combining humanised anti-CD20 (veltuzumab), anti-CD22 (epratuzumab) or both<br />
monoclonal antibodies with chemotherapy in adults with recurrent B-precursor acute lymphoblastic leukaemia<br />
(ALL) – MARALL<br />
Phase-II study evaluating midostaurin in induction, consolidation and maintenance therapy also after allogeneic<br />
blood stem cell transplantation in patients with newly diagnosed acute myeloid leukemia exhibiting a FLT3<br />
internal tandem duplication<br />
Molecular and Functional Characterisation of Bone Marrow Function in Normal Subjects, Myelodysplastic<br />
Syndrome and Secondary Disorders of Haematopoiesis<br />
Multicenter prospective trial estimating the persistence of molecular remission in chronic myeloid leukemia after<br />
stopping TKI<br />
An open-label, multi-center study investigating the safety and efficacy of Ofatumumab therapy versus physicians'<br />
choice in patients with bulky Fludarabine refractory chronic lymphocytic leukaemia (CLL)<br />
A Randomized Phase II, Open-Label Study of the Efficacy and Safety of Orally Administered SAR302503 in<br />
Patients With Polycythemia Vera (PV) or Essential Thrombocythemia (ET) Who Are Resistant or Intolerant to<br />
Hydroxyurea<br />
Double-blind, Randomised, Placebo-controlled Multicentre Phase III Clinical Study Followed by Open-label Phase<br />
on the Efficacy and Tolerability of Budesonide 3 mg Effervescent Tablet in Patients With Resistant Oral Chronic<br />
GvHD<br />
A Single-arm Dose-finding Phase Ib Multicenter Study of the Oral Smoothened Antagonist LDE225 in<br />
Combination With Nilotinib in Chronic Phase Chronic Myeloid Leukemia Patients Who Have Failed Prior<br />
<strong>The</strong>rapy With Other BCR-ABL Tyrosine-kinase Inhibitors<br />
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients<br />
with In<strong>term</strong>ediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential<br />
Thrombocythemia Myelofibrosis with Splenomegaly<br />
Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based<br />
Conditioning and HCT From Related and Unrelated Donors as Consolidation <strong>The</strong>rapy for Older Patients With<br />
AML in 1st Complete Remission<br />
An Open-Label, Randomized Phase 3 Study Of Inotuzumab Ozogamicin Compared To A Defined Investigator's<br />
Choice In Adult Patients With Relapsed Or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL)<br />
A Multicenter, Randomised, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of<br />
Anaemic Subjects With Low or In<strong>term</strong>ediate-1 Risk Myelodysplastic Syndrome (MDS)<br />
A Single-arm, Multicenter, Nilotinib Treatment-free Remission Study in Patients With BCR-ABL1 Positive<br />
Chronic Myelogenous Leukemia in Chronic Phase Who Have Achieved Durable Minimal Residual Disease<br />
(MRD) Status on First Line Nilotinib Treatment<br />
A Phase 3 Randomized,Open-Label Study of Ponatinib Versus Imatinib in Adult Patients With Newly Diagnosed<br />
Chronic Myeloid Leukemia in Chronic Phase<br />
Polycythemia Vera Symptom Study Evaluating Ruxolitinib Versus Hydroxyurea in a Randomized, Multicenter,<br />
Double-Blind, Double-Dummy, Phase 3 Efficacy and Safety Study of Patient Reported Outcomes<br />
A Phase 2 Study of LY2784544 in Patients With Myeloproliferative Neoplasms<br />
A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated With<br />
Ruxolitinib and With a Current Diagnosis of In<strong>term</strong>ediate or High-Risk Primary Myelofibrosis, Post-Polycythemia<br />
Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis<br />
Iron overload in MDS patients: <strong>The</strong> value of new iron parameters and MRI T2* of heart and liver as predictor of<br />
iron overload<br />
A non-interventional observational post authorisation study to evaluate safety and efficacy in patients receiving<br />
azacitidine in daily clinical practice in the Netherlands<br />
22
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