Novembre 2014 Pathologie Etude Spécifications Remarques Sponsor N°protocol Bordet Age ≥ 18yo Untreated AML (except M3-M7) Age ≥ 18yo Induction + Eltrombopag vs placebo Erasm Brugm Ste ann Pierre MontGodinne ER AML de novo or secondary AML Vaccination in consolidation for T-cell depleted patients (Acute Myeloid Leukemia ) AML in CR1 not eligible for alloHSCT (favourable genetics are excluded) Anti-wt-1 LAL IJB CHUB WT1 overexpression at diagnosis or first relapse Arsenic trioxide +/- ATRA LA promyélocytaire AML relapse/refactory-FLT3 pos AC220 vs salvage therapy Clofarabine added to induction and consolidation First line No symptomatic cardiac disease-no previous myocardial infarction Age ≥ 18yo T(15;17) and/or PML-RARA No QT prolongation Eltrombopag vs placebo Age 18-70 yo Untreated T cell or B cell ALL AML or MDS with thrombocytopenia First line and pretreated APL2006 IJB Ambit Ø Ø Ø MYDY IJB AML in CR2 or CR3 not eligible for alloHSCT LANL Ø Ø HOVON IJB GSK IJB Age ≥ 18yo Platelets < 25000 due to BM insufficiency Platelets ≥ 25000 due to transfusion Ø Platelet transf or symptom bleeding or platelets < 10000 within weeks Ø No systemic treatment Ø ER Stable disease No MDS IPSS low risk or intermediate-1 risk Spleen size < 16 cm (sonography) Age ≥ 18yo LMC en Mol PR-ENEST Path LMC MYELOFIBROSE LLC A Phase IIIb, Multicentre, Open-label Study of Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome and/or BCR-ABL Positive CML in Chronic Phase First line Glivec ≥ 2 years PERSIST-2 Pacritinib vs Best therapy pour les myélofibrose (pas plus de 6 mois de Ruxolitinib antérieurement) 1ère ligne - observationnel IPI145 per os (inhib PI3K) vs ofatumumab Rechute R-benda vs R-ABT199(inh BCL2) Rechute Ø ≥ 2nd line therapy Ø Cross over possible Ø Age ≥ 18 yo Ø CLL Rituximab 2g/month for 4 months Ø 2nd line to 4th therapy Ø Age ≥ 18yo Etude de l’impact de différents facteurs pronostiques de l’interaction avec le microenvironnement médullaire et du CLL/LLC : Envoi d'échantillons de mécanisme pro-apoptotique du valproate sur les lymphocytes sang B de patients atteints de Leucémie Lymphoïde Chronique (LLC) Ritux-Benda + Idélalisib(inh PI3K) vs placebo ER Novartis CAMN107 EIC01 CHUB Cell Therapeutics PAC-326 CHUB Ø Age ≥ 18 yo Ø First line Ø Stage Binet B or C Ø Not eligible for Fludarabine treatment Ø Age ≥ 18 yo Ø CLL/SLL LEVACT MRD after chemo Novartis Mol PR (MR <4.0) Suivi de réponse moléculaire A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, PostPolycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis A MULTICENTER, PHASE III, OPEN-LABEL, RANDOMIZED STUDY IN RELAPSED/REFRACTORY PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA TO EVALUATE THE BENEFIT OF GDC-0199 (ABT-199) PLUS RITUXIMAB COMPARED WITH BENDAMUSTINE PLUS RITUXIMAB 2/11/14 Tasigna for 2 years – rando if molCR: Tasigna 1 year vs stop IJB IPI-07-Infinity Roche Ø Age ≥ 18 yo Ø 1 lymph node ≥ 2cm x 1cm Etudes cliniques.xls IJB IJB HYDRIC-UCL ER IJB MURANO : GDC-0199+Ritux vs Bendamustine+Ritux en 2ème à 4ème ligne ER IJB F. Hoffmann-La Roche Ltd/ AbbVie Inc GO28667 Gilead GS-0123 CHUB CHUB IJB 1 Pathologie Etude Spécifications Ritux+Len vs Ritux+chemo and Ritux maintenance 1ère ligne Folliculaires Rituximab refractory-OMB110918 Rechute/réfractaire Benda +/- ofatumumab SLL, MZL, Fol Rituximab sensitive-OMB113676 Rechute/réfractaire Ofatumumab vs rituximab Folliculaires LEVACT Rechute/réfractaire Observationnel A Phase IIa, Open-label, Multicenter Study of Single-Agent 2éme L et + (Après traitement par MOR00208, an Fc-optimized Anti-CD19 Antibody in Patients Ritux) Pas de limtation de ligne With Relapsed or Refractory Non-Hodgkin´s Lymphoma (NHL) LYMPHOMES NON-HK INDOLENTS Alternating R-CHOP or R-HAD - R-CHOP + maintenance Ritux1ère ligne Len vs Ritux GA101+lenalidomide Rechute/réfractaire R-benda or R-CHOP + ibrutinib vs placebo Rechute/réfractaire IPI-145+ritux vs ritux Rechute/réfractaire A Phase III, randomized, double-blind, placebo controlled study evaluating the efficacy and safety of copanlisib in combination with rituximab in patients with relapsed indolent B-cell non Hodgkin's lymphoma (iNHL). Ø CD20+ follicular NHL gr 1-2-3a Ø Age ≥ 18 yo Ø St II -III- IV Ø follicular gr 1-3a–small lymphocytic–lymphoplasmacytic–marginal zone Ø St I to IV Ø ≥ 18 yo Ø follicular gr 1-3a Ø PD following response to rituximab treatment Ø Age ≥ 18 yo Ø St I to IV Ø Age ≥ 18 yo Ø Refractory (NR or PD < 6 months) after Rituximab Ø All indolent NHL Ø Age ≥ 18 yo Ø 2nd to 5th line therapy Ø Fol Ø Age ≥ 18 yo Ø ≥ 2nd line Ø Relapse or refractory after θ anti CD20 Ø MZL Ø Age ≥ 60 yo Ø Cyclin D1 pos or t(11 ;14)(q13 ;32) Ø Ineligible for intensive treatment Ø Follicular-MCL-DLBCL Ø Age ≥ 18 yo Ø ≥ 2nd line – anterior rituximab containing regimen Ø Age ≥ 18 yo Ibrutinib (max 3 years) Single agent therapy PCYC-1121 Remarques Ø ≥ 2th line therapy (including anti CD20 θ) Ø ≥ 1 lymph node ≥ 1.5 cm(long axis) Ø Age ≥ 18 yo Ø Follicular NHL Lymphomes non Hodgkininens indolents. 2° ligne. Combinaison copanlisib et rituximab. Sponsor 1ère ligne IPI 0 Randomized Phase III Study Using a Pet-driven Strategy and Comparing GA101 OR Rituximab Associated to a Chemotherapy Delivered Every 14 Days (ACVBP or CHOP) in DLBCL CD20+ Lymphoma Untreated Patients From 18 to 60 Presenting With 1 or More Adverse Prognostic Factors of the Age-adjusted IPI GA101 versus Ritux avec ACVBP ou CHOP-14 en 1ère Ligne. Patient 18 - 60 ans entre 18 et 60 ans avec au moins 1 Au moins un facteur de mauvais pronostic à l'IPI facteur de mauvais pronostic à l' IPI. R-CHOP + ibrutinib vs placebo 1ère ligne 18 - 80 ans Bordet GELA RELEVANCE IJB GSK IJB GSK IJB IJB MorphoSys MOR208C201 IJB Pharmacyclics PCYC-1121 IJB LYSA MCL-R2 IJB GELA GALEN IJB SELENE J&J IJB IPI-145-08 / Infinity Bayer LNH09-1B N°protocol GAINED MontGodinne ER ER CHUB IJB BAY 806946/17067 LYSA LYSARC Erasm Brugm Ste ann Pierre CHUB IJB ER IJB ER CHUB Age ≥ 18 yo Non GCB DLBCL IPI ≥1 J&J PHOENIX IJB MORPHOSYS IJB GELA-GALEN IJB Stage AA II-III-IV LYMPHOMES NON-HK DIFFUS A GRANDES CELLULES B 2/11/14 MOR00208 Rechute/réfractaire anti CD19 MoAB GA101+lenalidomide Rechute/réfractaire modified Age ≥ 18 yo 2nd to 5th line therapy Follicular-MCL-DLBCL Age ≥ 18 yo CHUB ≥ 2nd line – anterior rituximab containing regimen A Comparative, Randomized, Parallel-group, Multi-centre, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20 Positive Diffuse Large B-cell Lymphoma (DLBCL) Ritux SC versus Ritux IV avec CHOP-14 en 1ère Ligne. Roche Mab Ease Double Blind Randomized Phase III Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP in First Line Lymphomes B diffus à grandes cellules: patient de + de 60 ans : entretien par lenalidomide vs placebo après 1ère ligne après RC ou RP Gelarc Remarc LNH 2009-6B SENIOR - LYSA SC-miniCHOP vs Ritux SC-miniCHOP+len 1ère ligne Ritux Etudes cliniques.xls LYSARC ER CHUB CHUB IJB 2 Pathologie Etude SENIOR - LYSA SC-miniCHOP vs Ritux SC-miniCHOP+len Spécifications Ritux Ibrutinib-lenalidomide ± rituximab LYMPHOME NON-HK ANAPLASIQUE LYMPHOME NON-HK T LYMPHOME DE HODGKIN MYELOME MULTIPLE Remarques 1ère ligne Rechute/réfractaire Crizotinib Romidepsin esc + CHOP 1ère ligne Brentuximab vedotin vs methotrexate or bexarothene Rechute/réfractaire ABVD+RXθ vs AVD+SGN-35 (brentuximab vedotin) Stage I-II unfavourable LEVACT 1ère ligne Observationnel Len-DEX ± MLN9708/placébo 1ère ligne Autologous Dentritic Cell Vaccination 1ère ligne Dex ± plitidepsin Rechute/réfractaire Daratumumab IV (anti CD38) Rechute/réfractaire 1ère ligne A Randomized, Open-Label Phase 3 Study of Filanesib (ARRY- Effet du carfilzomib+filanesib vs 520) + Carfilzomib Versus Single Agent Carfilzomib in Patients carfilzomib en 2ème ligne ou + with advanced multiple myeloma. (après velcade et Ib) Filanesib (inh SKP) Rechute/réfractaire 2/11/14 DREPANOCYTOSE Bordet Pharmacyclics PCYC-1123 IJB Ø Tumor block for central review is mandatory) Ø Incurable disease by conventional therapy EORTC 90101 IJB Ø Peripheral T cell lymphoma Ø Age 18-70 yo Ø Pas HTLV-1 NHL-ALK+PTCL-cutaneous TCL Ø pcALCL:≥2e line(θ syst) or post RXθ Ø MF:≥2eline (θ syst) Ø Age ≥18 yo Ø CD30pos (to confirm by central lab on biopsy) Ø Age >18-70yo Ø CD30+ Ø Supra-diaphragmatic stage I-II unfavourable HD Ø Age > 65 yo Ø Front line Ø Staging DS II-III Ø No neuropathy Ø Not eligible for ASCT Ø Age ≥ 18 yo Ø Not eligible for intensive treatment Ø Age ≤ 65 yo Ø VGPR after first-line ASCT Ø Age ≥ 18 yo Ø 4nd to 7th line therapy Ø Relapse after Velcade and Revlimid Ø Age ≥ 18 yo Ø ≥ 2nd line (at least PR at 1 line) Ø Not refactory or intolerant to lenalidomide Ø Light chain involvement permitted Ø Age ≥ 65 yo Ø Clearance creatinine >30ml/min Ø Age ≥ 18 yo Ø 3th to 7th line (including Velcade & IMiD) Ø Light chain involvement permitted Ø Age ≥ 18 yo Ø 3th line (including ≥ 2 cycles Velcade & ≥ 2 cycles Revlimid regimen) Ø Refractory to carfilzomib and/or pomalidomide Ø Light chain involvement permitted Etudes cliniques.xls Erasm Brugm Ste ann Pierre CHUB LYSA IJB ER Millenium IJB ER LYSA BREACH IJB IJB Millenium MontGodinne IJB Ø Phase 1 : DLBCL Ø Phase 2 : DLBCL non-GCB Ø ≥ 2nd line – ineligible for intensive treatment Ø 1 lymph node ≥ 1.5cm A Phase III, randomized, double-blind, placebo controlled Lymphomes non Hodgkininens study evaluating the efficacy and safety of copanlisib in indolents. 2° ligne. Combinaison combination with rituximab in patients with relapsed indolent copanlisib et rituximab. B-cell non Hodgkin's lymphoma (iNHL). Anomalies du strain longitudinal, évalué par speckle tracking, chez les patients drépanocytaires Prise en charge en urgence de la douleur des crises vasoocclusive Evaluation du potentiel hémostatique chez les adultes drepanocytaires N°protocol LYSARC Phase III Study of Lenalidomide and Dexamethasone With or Récidive ou réfractaire (2ème à Without Elotuzumab to Treat Relapsed or Refractory Multiple 4ème ligne) Myeloma (ELOQUENT - 2) Melphalan - Prednisone– Carfilzomib induction carfilzomib 1 year maintenance Sponsor C-16014 IJB MYVAC2 IJB ER IJB IJB BMS CA2004004 CHUB IFM 2012-03 IJB Array BioPharma ARRAY-520311 IJB Array Biopharma ARRAY-5203215 IJB Bayer BAY 806946/17067 CHUB CHUB CHUB CHUB CHUB CHUB CHUB CHUB 3 Pathologie DREPANOCYTOSE HPN NUTRITION MEDICAL NEED PROGRAM Etude Spécifications Remarques Qualité de la transition entre service enfant et adulte Sponsor N°protocol Bordet CHUB Erasm Brugm Ste ann Pierre CHUB HUDER F / CHUB Comparaison transplantation de cellules souches HLA matché versus HLA-haploïde identique IJB NAC Réduction de la douleur journalière par la NAC dans la drépanocytose Pays-Bas BHS NAC CHUB Quantification des microvésicules Hémoglobinurie paroxystique nocturne UCL MontGodinne HPN CHUB IRIS IRIS JFN2014 Comparison of outcomes after stem cell transplantation in HLA matching vs HLA haploid identical Evaluation du risque de dénutrition et de la dénutrition dans un hôpital de Jour oncologique. RITUXIMAB VALACYCLOVIR BRENTUXIMAB VEDOTIN EVOLTRA (clofarabine) BLINOTUMUMAB LENALIDOMIDE GEMCITABINE OFATUMUMAB IBRUTINIB AHAI, EBV+, NHL, ITP, autres Greffe allogène HK, ATCL AML ALL 5qBMS CLL, NHL MCL, LLC POMALIDOMIDE MM double réfractaire ou intolérant BOSUTINIB MAB CAMPATH LMC après une ligneTKI IJB IJB MontGodinne CHUB HSP BHS BHS Takeda Janssen Amgen Celgène GSK Janssen Pfizer Sanofi Etude en cours et recrutante Etude en cours mais fermée à l'inclusion Etude en cours d'ouverture 2/11/14 Etudes cliniques.xls 4
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