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Etudes en cours: Hématologie Adulte

 

LNH indolent

 

1ère ligne

Sub-cutaneous Rituximab-miniCHOP versus Sub-cutaneous Rituximab-miniCHOP + lenalidomide (R2-miniCHOP) in Diffuse Large B Cell lymphoma for patients of 80 years old or more. A multicentric phase III study of the LYSA. SENIOR

Contact: G. Dembour 02/764 18 38

 

Efficacy and Safety of Rivaroxaban Prophylaxis Compared with Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism. Cassini

Contact:K. Van Renterghem 02/764 18 79 


≥ 2ème ligne

Efficacy and Safety of Rivaroxaban Prophylaxis Compared with Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism. Cassini

Contact:K. Van Renterghem 02/764 18 79 

 

LNH haut grade

 

≥ 2ème ligne

A randomized multicenter Study comparing Pixantrone + Rituximab in Patients with agressive B-cell non-hodgkin Lymphoma who have relapsed after therapy with CHOP-R or an equivalent and are ineligible for stem cell transplant. PIX 306 

Contact: C. Pedreira 02/764 18 10 

 

A phase 2b Open-label, Randomized Two-arm Study Comparing High and Low Doses of Selinexor (KPT-330) in Patients with Relapsed/ Refractory Diffuse Large B-Cell Lymphoma (DLBCL). KCP-330-009

Contact:K. Van Renterghem 02/764 18 79 

 

A multicenter, open-label phase 1b/2 study of the Bruton's tyrosine kinase (BTK) inhibitor, Ibrutinib, in combination with lenalidomide and rituximab in subject with R/R diffuse large B cell lymphoma. PCYC1123-CA

Contact: A. Bourgois 02/764 18 10

 

A phase 1A/1B, multi-center, open-label, dose finding study to assess the safety, tolerability, pharmacokibetics and preliminary efficacy of the pleiotropic pathway modifier CC-122 administered orally to subjects with advanced solid tumors, non-hodkin's lymphoma or multiple myeloma (analog of thaledomide). CC-122-ST-001

Contact: A. Moxhon 02/764 42 17

 

A phase 4, open-label, single-arm study of Brentuximab Vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. C25006

Contact: A. Bourgois 02/764 18 10

 

A Retrospective and Prospective Observational Study of Ibrutinib Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice. BIRD (Registre)

Contact:K. Van Renterghem 02/764 18 79 

 

Hodgkin

 

1ère ligne

A prospective phase II study of bendamustine in patients aged over 60 years with classical Hodgkin lymphoma treated by prednisone, vinblastine and doxorubicin. PVAB

Contact: A. Bourgois 02/764 18 10

 

LMA MDS

Randomized study with a run-in dose-selection phase to assess the added value of lenalidomide in combination with standard remission-induction chemotherapy and post-remission treatment in patients aged 18-65 years with previously untreated acute myeloid leukemia (AML) or high-risk myelodysplasia (MDS) (IPSS-R risk score > 4,5). HOVON 132

Contact:K. Van Renterghem 02/764 18 79 

 

A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral lenalidomide to standard induction therapy in AML and RAEB ≥ 66 years and very poor risk AML ≥ 18 years. HOVON 103

Contact: A. Charlot 02/764 18 09

 

A randomized, double-blind phase 3 study of vadastuximab talirine (SGN-CD33A) versus placebo in combination with azacitidine or decitabine in the treatment of older patients with newly diagnosed acute myeloid leukemia (AML). Cascade (SGN33A-005)

Contact: C. Pedreira 02/764 18 10

 

Wilms'tumor antigen-targeded dendritic cell vaccination to prevent relapse in patients older than 65 years with acute myeloid leukemia : a multicenter randomized phase II trial. WT1 (Widea)

Contact: C. Pedreira 02/764 18 10

 

A randomized, multicenter, open-label,phase 2 study evaluating the efficacy and safety of azacitidine subcutaneous in combination with durvalumab (MEDI4736) in previously untreated subjects with highter-risk myelodysplastic syndromes (MDS) or in elderly (>=65 years) acute myeloid leukemia ( AML) subjects not eligible for hematopoietic stem cell transplantation (HSCT). Fusion

Contact: C. Pedreira 02/764 18 10

 

A phase 2/3 Multicenter, Open-label, 3-arm, 2-stage Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy. LACEWING

Contact:K. Van Renterghem 02/764 18 79 

Temporairement fermé à l'inclusion

 

≥ 2ème ligne

A phase 3 open-label randomized study of quizartinib (AC220) monotherapy versus salvage chemotherapy in subjects with FLT3-ITD positive acute myeloid leukemia (AML) refractory to or relapsed after first-line treatment with or without hematopoietic stem cell transplantation (HSCT) consolidation. AMBIT

Contact: C. Pedreira 02/764 18 10

 

Première étude chez l'homme avec MEN1112, un anticorps monoclonal dirigé contre le CD-157, dans la leucémie myeloïde aiguë récidivante ou réfractaire. MENARINI/ARMY 

Contact: A. Bourgois 02/764 18 10

(recrutement en suspend actuellement- comité d'éthique en cours, ré-ouverture dans les prochaines semaines)

 

Une étude pilote de phase II pour évaluer la présence de facteurs moléculaires afin de déterminer lesquels sont prédictifs pour une réponse hématologique chez les patients atteints du syndrome myelodysplasique traités par le déférasinox dans les centres hématologiques en Belgique par profilage d'expression des gènes sur des échantillons de moelle osseuse. EXPHAR

Contact: C. Pedreira 02/764 18 10

 

A randomized, open-label, phase II study of  the selective inhibitor of nuclear export (sine) selinexor (KCP-330) versus specified physician's choice in patients >=60 years old with relapsed/refractory acute myeloÏd leukemia who are ineligible for intensive chemotherapy and/or transplantation. KCP-330-008

Contact: A. Bourgois 02/764 18 10

 

MDS

 

1ère ligne

ÉTUDE DE PHASE I-II DE L’ASSOCIATION DEFERASIROX VITAMINE D ET D’AZACITIDINE DANS LE TRAITEMENT DES SYNDROMES MYELODYSPLASIQUES DE HAUT RISQUE (IPSS INT-2 et ÉLEVÉ). GFM-EXVD-AZA

Contact: G. Dembour 02/764 18 38

 

≥ 2ème ligne

ÉTUDE DE PHASE I-II DE L’ASSOCIATION DEFERASIROX VITAMINE D ET D’AZACITIDINE DANS LE TRAITEMENT DES SYNDROMES MYELODYSPLASIQUES DE HAUT RISQUE (IPSS INT-2 et ÉLEVÉ). GFM-EXVD-AZA

Contact: G. Dembour 02/764 18 38

 

LLA

 

1ère ligne

Clofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults. HOVON 100

Contact: A. Bourgois 02/764 18 10

 

Multicenter trial for the treatment of Acute Lymphoblastic Leukemia (ALL) in younger adluts (18-59 YO). GRAALL 2014

Contact: A. Bourgois 02/764 18 10

 

A phase II multicenter study (CTL019) with CD19 CAR T cells for patients with relapsed or refractory B_ALL patients. CAR T

 

LLC

 

1ère ligne

A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination with Chlorambucil, ACP-196 in Combination with Obinutuzumab, and ACP-196 Monotherapy in Subjects with Previously Untreated Chronic Lymphocytic Leukemia. ACE-CL-007                   

Contact: A. Charlot 02/764 18 09

(fin recrutement février 2017)

 

A Retrospective and Prospective Observational Study of Ibrutinib Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice. BIRD (Registre)

Contact:K. Van Renterghem 02/764 18 79 

 

≥ 2ème ligne

A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase 3 Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia. ACE-CL-006

Contact: A. Charlot 02/764 18 09

 

A Retrospective and Prospective Observational Study of Ibrutinib Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice. BIRD (Registre)

Contact:K. Van Renterghem 02/764 18 79 

 

A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy. ACE-CL-208

Contact:K. Van Renterghem 02/764 18 79 

 

Open-label, single arm, Phase 3b, multi-center study evaluating the efficacy of Venetoclax (ABT-199) in relapsed/refractory subjects with chronic lymphocytic leukemia (CLL) including those with the 17p deletion or TP53 mutation or those who are refractory or intolerant to B-cell receptor inhibitors. VENICE 1 ( M15-550)

Contact: C. Pedreira 02/764 18 10

 

LMC

 

≥ 2ème ligne

A Randomized, Open-label Study of Ponatinib versus Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase following Resistance to Imatinib Chronic Myeloid Leukemia in Chronic Phase following Resistance to Imatinib. Optic-2L 

Contact:K. Van Renterghem 02/764 18 79 

 

SMP

A Randomized, Single-Blind, Multicenter Phase 2 Study to Evaluate the Activity of 2 Dose Levels of Imetelstat in Subjects with Intermediate-2 or High-Risk Myelofibrosis (MF) Relapsed/Refractory to Janus Kinase (JAK) inhibitor. MYF 2001

Contact:K. Van Renterghem 02/764 18 79 

 

Myelome

 

1ère ligne

Etude du daratumumab (JNJ-54767414 (HuMax® CD38)) en association avec le bortézomib (Velcade®), la Thalidomide, et la Dexaméthasone (VTD) dans le traitement de première ligne de patients atteints d?un myélome multiple nouvellement diagnostiqué et éligibles à une greffe. CASSIOPEIA

Contact: A. Bourgois 02/764 18 10

 

A phase 3 study comparing Daratumumab, Lenalidomide and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in subjects with previously untreated Multiple Myeloma who are ineligible for high dose therapy. MAIA

Contact: A. Bourgois 02/764 18 10

 

≥ 2ème ligne

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation. C16021

Contact:K. Van Renterghem 02/764 18 79

 

A phase 1A/1B, multi-center, open-label, dose finding study to assess the safety, tolerability, pharmacokibetics and preliminary efficacy of the pleiotropic pathway modifier CC-122 administered orally to subjects with advanced solid tumors, non-hodkin's lymphoma or multiple myeloma (analog of thaledomide). CC-122-ST-001

Contact: A. Moxhon 02/764 42 17 

A. Charlot 02/764 18 09

 

Greffes

 

Busulfan dosage in allogeneic stem cell transplant recipients receiving PO Busulfan containing conditioning regimens.TJB1122

Contact: C. Pedreira 02/764 18 10

 

Allogeneic hematopoietic cell transplantation from HLA-matched donors after reduced-intensity conditioning: a phase II randomized study comparing 2 GVHD pophylaxis regimen.TJB1016

Contact: C. Pedreira 02/764 18 10

 

Randomized double-bind study of mesenchymal stem cells (MSC) in patients undergoing matched unrelated allogeneic bone marrow or peripheral blood stem cell transplantation - A European multicenter study. TJB0603

Contact: C. Pedreira 02/764 18 10

 

Co-transplantation of mesenchymal stem cells and HLA mismatched allogeneic hematopoietic cells after reduced intensity conditioning: a phase II randomized double-bind study. TJB0909

Contact: C. Pedreira 02/764 18 10

 

Allogeneic hematopoietic cell transplantation with HLA-matched donors: a phase II randomized study comparing 2 non myeloablative conditionings, TJB0702

Contact: C. Pedreira 02/764 18 10

 

Sequential administration of 5-azacytidine and donor lymphocyte infusion for patients with acute myelogenous leukemia and myelodysplastic syndrome in relapse after allogeneic stem cell transplantation. BHS-TC-10 (TJB1302)  (Reste 1 place)

Contact: C. Pedreira 02/764 18 10

 

A phase II study to assess the safety and the efficacy of extracorporeal photopheresis using the Theraflex ECP for patients with refractory chronic GVHD. PHOTOPHERESE THERAFLEX

Contact: A. Charlot 02/764 18 09

 

Divers

 

Etude observationnelle des facteurs responsables de néphropathie des patients drépanocytaires. Drépano Biobanque

Contact: C. Pedreira 02/764 18 10

 

Etude phase 3 double aveugle, testant l'efficacité et la securité du Caplacizumab chez les patient qui ont un Purpura  Thrombotique Thrombocytopenique. Ablynx

Contact:K. Van Renterghem 02/764 18 79

 

Efficacy and Safety of Rivaroxaban Prophylaxis Compared with Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism. Cassini

Contact:K. Van Renterghem 02/764 18 79

 

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