Trials

Behandelschema patiënt Carthadex 45 mg Behandelschema patiënt Carthadex 56 mg NB: doseringen afhankelijk van cohort. Inclusion Criteria Patients with a confirmed diagnosis of multiple myeloma stage I to III according to the ISS criteria (see appendix I); Age 18-65 years inclusive; WHO performance status 0-3 (WHO=3 is allowed only when… Lees meer >

Patients with Multiple Myeloma, ISS stage I -III age 18-65 yrs (must be transplant candidates) at first presentation; 145 patients. Study design: For patient numbers 111 to 145: Induction treatment (before HDM/ASCT): Carfilzomib 20mg/m2 for days 1,2, then 56mg/m2 days 8,9,15,16 of cycle 1, then 56mg/m2 throughout next cycles. Thalidomide… Lees meer >

Inclusiecriteria CD20/CD22 positief folliculair of diffuus grootcellig B-cel lymfoom volgens WHO classificatie, met progressie na 1 of 2 lijnen chemotherapie. In tenminste een lijn rituximab. Geen progressie tijdens rituximab of binnen 6 maanden na de laatste gift. ≥ 18 jaar. ECOG performance status ≤ 2. Levensverwachting ≥ 12 weken. Neutrofielen… Lees meer >

Inclusiecriteria Klassiek Hodgkin lymfoom. Stadium I en II boven het diafragma, favourable en unfavourable. Leeftijd 15-70 jaar. FDG-PET scan prospectief gepland na 2 cycli ABVD. WHO performance status graad 0,1,2 of 3. Afwezigheid ernstige cardiale, pulmonale, neurologische, psychiatrische of metabole ziekten. Written informed consent. Exclusiecriteria Nodulaire lymfocyten-predominante Hodgkin lymfoom. Zwangerschap… Lees meer >

Inclusiecriteria Patiënten met cytologisch of histologisch bevestigde diagnose Hodgkin’s of non-Hodgkin’s lymfoom volgens de WHO-classificatie. Patiënten die tenminste 1 eerder behandelingsschema voor Hodgkin’s of non-Hodgkin’s lymfoom hebben gehad, en momenteel behandeling vereisen ivm refractaire ziekte, recidief of progressie. Aanwezigheid van SS receptoren op de bekende tumorlesies, aangetoond met OctreoScan binnen… Lees meer >

Originele protocol Schema HOVON 101 protocol Inclusie criteria CR of PR na 2de/3de lijns behandeling de behandeling voor inclusie is in ieder geval 4 maanden monotherapie alkylerend middel en/of tenminste 4 cycli polychemotherapie (bijv. CVP), fludarabine-bevattende chemotherapie of immunochemotherapie WHO PS 0-2 informed consent Exclusie criteria primair of secundair fludarabine-refractaire… Lees meer >

Originele protocol Inclusion criteria Age 18-65 years, inclusive Subjects with a cytopathologically confirmed diagnosis of AML according WHO classification (excluding acute promyelocytic leukaemia) or a diagnosis of refractory anemia with excess of blasts (RAEB) and IPSS score >=1.5 or patients with therapy-related AML/RAEB or patients with biphenotypic leukemia (Appendices A1… Lees meer >

Originele protocol Inclusion criteria  Patients eligible for standard chemotherapy.  Patients 66 years and older   Patients with a diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML, or acute leukemia’s of… Lees meer >

Inclusion criteria Biopsy proven, systemic, untreated AL amyloidosis requiring systemic chemotherapy, Age 18 -70 years inclusive at the time of signing the informed consent form, Measurable plasma cell dyscrasia, defined as a detectable M-protein with serum electrophoresis and/or level of involved FLC > 50 mg/L, Life expectancy > 3 months,… Lees meer >

Originele protocol Inclusion criteria Patients with a histologically confirmed diagnosis of CD20 positive DLBCL based upon a representative histology specimen of brain biopsy according to the WHO classification (see appendix A):OR Patients with a diagnosis of PCNSL based on MRI evidence of brain parenchymal lesion showing homogeneous contrast enhancement suspect… Lees meer >

Originele protocol Summary A randomized phase II study for evaluation of T cell depleted non-myeloablative allogeneic stem cell transplantation followed by early consolidation with lenalidomide or lenalidomide combined with bortezomib and subsequent DLI for patients with multiple myeloma in progression or relapse following first line therapy Inclusion criteria Patients with… Lees meer >

Originele protocol Summary Efficacy and toxicity of lenalidomide and rituximab with or without bendamustine in patients ≥ 18 years with relapsed follicular lymphoma Inclusion criteria Relapsed FL grade 1, 2, 3a; Ann Arbor stage II-IV at relapse; The lymphoma at relapse must be CD20+. To establish this, and to exclude… Lees meer >

Originele protocol Inclusion criteria Grade II-IV acute GvHD with gut and/or liver involvement, confirmed by histology of involved tissues (in case of gut and liver involvement histology of either one of these tissues is considered sufficient); N.B. if the patient is otherwise eligible but histological confirmation at randomization is lacking,… Lees meer >

Originele protocol Pomalidomide combined with Carfilzomib and Dexamethasone (PCd) for induction and consolidation followed by Pomalidomide combined with Dexamethason vs Pomalidomide maintenance for patients with Multiple Myeloma in first relapse after prior 1st line treatment with Lenalidomide and Bortezomib Inclusion criteria Included in EMN02/HO95 trial The subject must understand and… Lees meer >

Originele protocol Eligibility for registration All patients must be registered before start of the second cycle of chemotherapy (either re-induction or first consolidation) and must meet all of the following eligibility criteria. Inclusion criteria Patients with poor-risk or very poor-risk AML or RAEB with IPSS ≥ 1.5 , (see appendix… Lees meer >

Originele protocol Inclusion criteria Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria (see appendix A) Age ≥ 75 years WHO performance status 0-3, WHO 4 performance status is allowed when related to MM (see appendix E) Measurable disease as defined by the presence… Lees meer >

Originele protocol Inclusion criteria Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria Measurable disease according to the IMWG criteria Age>65 years or patients ≤65 not eligible for ASCT Performance status 0-3 for patients <75 years and WHO performance status 0-2 for patients ≥… Lees meer >

Originele protocol Carfilzomib and lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patientsA European Intergroup Trial of the European Myeloma Network EMN (EMN12/HO129 PCL) Inclusion criteria Patients with diagnosis of symptomatic pPCL (see appendix A) Measurable disease as defined by the presence of M-protein in serum… Lees meer >

Originele protocol Inclusion criteria Age 18-65 years, inclusive Patients with a diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML), or acute leukemia’s of ambiguous lineage according to WHO 2008… Lees meer >

Originele protocol Inclusion criteria Patients with: a diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML, or acute leukemia’s of ambiguous lineage according to WHO 2008 or a diagnosis of… Lees meer >

Originele protocol Inclusion criteria Informed consent Women or men with a newly diagnosed APL by cytomorphology, confirmed by molecular analysis* Age ≥18 and ≤ 65 years ECOG performance status 0-3 WBC at diagnosis > 10 GPt/l Serum total bilirubin ≤ 3.0 mg/dl (≤ 51 μmol/l) Serum creatinine ≤ 3.0 mg/dl… Lees meer >

Originele protocol Inclusiecriteria Histologisch bevestigd mantelcellymfoom volgens de WHO classificatie, bij voorkeur voor inclusie bevestigd door centrale PA-review. Klinisch stadium II, III, of IV. Tevoren onbehandeld. 65 jaar of ouder, of patiënten tussen 60 en 65 jaar die niet in aanmerking komen voor hoge dosis therapie. WHO performance status ≤… Lees meer >

Originele protocol Schema HOVON 68 protocol Inclusie criteria Leeftijd 18-75 jaar Biologisch hoog risico CLL (ongemuteerde IgVH genen en/of gemutateerde CLL met VH3-21 en/of FISH met 17p deletie en/of 11q deletie en/of trisomie 12. Patiënten met symptomatische CLL, Binet A of B of Binet C (zie tabel criteria actieve ziekte)… Lees meer >

Originele protocol Inclusiecriteria Patiënten met histologische en immunologisch bewezen diagnose mantelcellymfoom (WHO classificatie). Ann Arbor stadium II-IV. CD20 positief. Leeftijd 18 t/m 65 jaar. WHO performance ≤ 2. Meetbare ziekte (geïsoleerde beenmerglokalisatie is geen contraindicatie). Schriftelijk informed consent. Exclusiecriteria Nierinsufficiëntie (kreatinineklaring < 50 ml/min). Bekende overgevoeligheid voor muizenantistoffen of mannitol…. Lees meer >

Originele protocol Schema

Originele protocol Inclusiecriteria > 65 jaar (of ≥ 60 jaar indien niet geschikt voor auto-PSCT). WHO performance status 0-2. Levensverwachting tenminste 3 maanden. Histologisch bevestigd CD20 positief diffuus grootcellig B-cel lymfoom (DLBCL) volgens de WHO classificatie. Eerstelijns inductietherapie met R-CHOP of R-CHOP-like chemotherapie (alleen CHOP met rituximab; CHOP 14 en… Lees meer >

Originele protocol Inclusiecriteria Leeftijd 18 – 65 jaar. Nieuw gediagnostiseerde patiënten met CML in eerste chronische fase ≤ 2 maanden. Philadelphia chromosoom of BCR-ABL positief. WHO performance status ≤ 2. Informed consent. Exclusiecriteria CML in geaccelereerde fase dan wel blastaire crise. Cardiale dysfunctie (NYHA classificatie II-IV). Pulmonaire insufficiëntie. Neurologische aandoening…. Lees meer >

Originele protocol Inclusion criteria Age 18-75 years ECOG performance status ≤ 3. Morphological diagnosis of APL (FAB-M3 or M3 variant). Those cases without typical morphology but with PML-RARa rearrangement should also be included. Genetic diagnosis: t(15;17) demonstrated by conventional karyotyping, PML-RARa rearrangement detected by RT-PCR or FISH, microspeckled PML protein… Lees meer >

Originele protocol Inclusiecriteria Agressief maligne B-cel lymfoom gebaseerd op een representatief histologisch biopt volgens WHO classificatie: folliculair lymfoom graad III; diffuus grootcellig B-cel lymfoom (DLBCL); tevoren laaggradig lymfoom met histologisch bewezen transformatienaar folliculair lymfoom graad III of DLBCL kan ook geïncludeerd worden. CD20 positief. Eerste progressie of relapse met CZS… Lees meer >

Originele protocol Randomized phase III study on the effect of early intensification of rituximab in combination with 2-weekly CHOP chemotherapy followed by rituximab maintenance in patients with diffuse large B-cell lymphoma Inclusion criteria Patients with a confirmed histologic diagnosis of diffuse large B-cell lymphoma (DLBCL) based upon a representative histology… Lees meer >

Originele protocol Klik hier voor flowschema.

Originele protocol Inclusiecriteria HOVON-86 Leeftijd 60-75 jr. 1e recidief MM. Meetbare ziekte. Niet eerder Bortezomib of Lenalidomide. NB: De doseringen in het fase 2 deel zijn nog tentatief: raadpleeg HOVON Datacentrum. Schema HOVON-86 trial Klik hier voor flowschema.

Originele protocol Doelstelling Onderzoeken waarde van Lenalidomide + MP vs standaard MPT. Inclusiecriteria Leeftijd > 65 jaar. Nieuw gediagnosticeerd symptomatisch multipel myeloom: monoklonale plasmacellen in BM of plasmacytoom; M-proteine in serum en/of urine; ROTI. Karnofsky score ≥ 60. Exclusiecriteria Eerdere chemotherapie, behalve een korte behandeling met corticosteroiden (equivalent met 4… Lees meer >

Originele protocol Inclusie criteria leeftijd 18-70 jaar fludarabine refractair (geen response of < 1 jaar na laatste fludarabine behandeling weer behandelindicatie) of refractair/recidief en behandelindicatie en 17p deletie of Refractair of recidief < 2 jaar na laatste fludarabine toediening in combinatie met monoclonaal antilichaam en behandelindicaite WHO performance status ≤… Lees meer >

Originele protocol Inclusion criteria Patients with MDS classified as RA, RARS and RAEB (with <10% myeloid blasts), CMML (with <10% myeloid blasts), according to FAB (see appendix A3) or RA, RARS, RCMD, RCMD-RS, RAEB-1, MDS-U according to WHO (see appendix A1) or patients with MPD/MDS (CMML-1 according to WHO) with… Lees meer >

Originele protocol Inclusion criteria Previously untreated patients with newly diagnosed peripheral T-cell lymphoma of stage I bulk (>= 7.5 cm) and stages II to IV. Patients with a confirmed histologic diagnosis of peripheral T-cell NHL according to the WHO classification (Appendix C): Peripheral T-cell lymphoma, unspecified (PTCL NOS) Angioimmunoblastic T-cell… Lees meer >

Originele protocol Inclusion criteria Age: 61 – 80 years Risk group: All risk groups, including stage I with bulk (≥ 7.5 cm) and stages II to IV, except stage I N without bulk and with no IPI risk factor besides the age over 60 Histology: Diagnosis of aggressive non-Hodgkin’s lymphoma,… Lees meer >

Originele protocol Randomized study to assess the added value of Laromustine in combination with standard remission-induction chemotherapy in patients aged 18-65 years with previously untreated acute myeloid leukaemia (AML) or myelodysplasia (MDS) (RAEB with IPSS ≥ 1.5). Inclusiecriteria Leeftijd 18 t/m 65 jaar. Patiënten met een door cytopathologie bevestigde diagnose… Lees meer >

Originele protocol Inclusion criteria Age ≥ 60years and ≤ 75 years AML as defined by WHO Refractory anaemia with excess of blasts (RAEB) primary and secondary AML First complete remission following one or two cycles of induction chemotherapy, according to current participating cooperative group protocols Karnofsky score > 70% (see… Lees meer >

Originele protocol Behandelschema patiënt Inclusion criteria Patients with a confirmed diagnosis of symptomatic multiple myeloma stage I to III according to the International Staging System ISS (see appendix A), i.e. at least one of the CRAB criteria should be present; Measurable disease as defined by the presence of M-protein in… Lees meer >

Originele protocol Inclusion criteria Age 60 years or more Subjects with a cytopathologically confirmed diagnosis of(a) AML (M0-M2 and M4-M7, FAB classification, appendix A), or(b) refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of blasts in transformation (RAEB-t) with an IPSS score of >1.5 (appendix C)… Lees meer >

Summary Originele protocol A phase III, parallel group, randomised, registration trial of ofatumumab versus rituximab in addition to salvage chemotherapy. Inclusion criteria CD20 positive DLBCL. Biopsies performed after termination of first-line treatment must confirm CD20 positive DLBCL. Refractory to, or relapsed following, first-line treatment with rituximab combined with anthracycline-based chemotherapy…. Lees meer >

Alle patiënten met verdenking longembolie kunnen worden geïncludeerd. De belangrijkste exclusie criteria zijn leeftijd < 18 jaar, levensverwachting < 3 maanden, behandeling met heparine meer dan 24 uur of gebruik van vitamine K antagonisten, contraïndicatie voor CT en zwangerschap. Na inclusie kan op de website van de studie (www.msbi.nl/prometheus, kies… Lees meer >

Selvedex trial Open label fase II studie (Inclusie in overleg met research-verpleegk. Erasmus MC hematologie) Inclusie Progressief of refractair symptomatisch Multipel  Myeloom Minimaal 1 voorgaande behandeling Exclusie Prior resistance/refractory disease to bortezomib Target number of patients: Part I: 6 patients per dose level of selinexor (MTD) Part II: 31 patients… Lees meer >