LLPC geassocieerde studies
Open studies
Naam | BYON4228 |
Titel | A first-in-human dose escalation and expansion study with the SIRPα-directed monoclonal antibody BYON4228 alone and in combination with rituximab to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy in patients with relapsed/refractory CD20 positive B-cell Non-Hodgkin’s Lymphoma (NHL) |
Status | Open in Amsterdam UMC, locatie VUMC (m.chamuleau@amsterdamumc.nl) and Nijmegen (wendy.stevens@radboudumc.nl) |
Medicatie | SIRPa inhibitor |
Populatie | relapsed/refractory CD20 positive B-cell Non-Hodgkin’s Lymphoma (NHL) |
Study info |
Part 1 (dose escalation): To evaluate the safety of BYON4228 alone and in combination with rituximab to determine the maximum tolerated dose (MTD), or optimal biological dose (OBD) if the MTD is not reached, and recommended combination dose regimen for expansion (RDE); |
Documenten |
Naam | M22-132 |
Titel | Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin Lymphoma |
Status | Open in Amsterdam UMC, locatie VUMC (m.chamuleau@amsterdamumc.nl), Groningen (m.nijland@umcg.nl), Maastricht (marjolein.vander.poel@mumc.nl) Leiden (j.s.p.vermaat@lumc.nl), Rotterdam (p.mutsaers@erasmusmc.nl) |
Medicatie | Epcoritamab (bispecific CD3xC20 antibody) |
Populatie | relapsed/refractory CD20 positive B-cell Non-Hodgkin’s Lymphoma (DLCBL, FL and MCL) |
Study info | Epcoritamab in Combination with Arm 1: Lenalidomide for R/R DLBCL Arm 2: Ibrutinib and lenalidomide for R/R DLBCL (post-CAR-T) Arm 3: Polatuzumab, rituximab, cyclophosphamide, doxorubicin HCl, and prednisone (pola-R-CHP) for treatment-naïve DLBCL Arm 4: CC-99282 for R/R DLBCL Arm 5: CC-99282 for R/R FL Arm 6: 6A: Ibrutinib; 6B: Ibrutinib and venetoclax for R/R MCL Arm 7: Ibrutinib and venetoclax for treatment-naïve MCL NB arm 3 and 7 not open in the Netherlands |
Documenten | In- en exclusiecriteria |
Naam | NX-5948-301 |
Titel |
A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton’s Tyrosine Kinase (BTK) Degrader, in Adults with Relapsed/Refractory B-cell Malignancies |
Status | open in ErasmusMC (j.doorduijn@erasmusmc.nl) en RadboudUMC (W. Stevens) |
Medicatie | BTK-degrader (oral) |
Populatie |
R/R CLL/SLL; DLBCL; tFL; Richter; high-grade B-cell lymphoma; FL; MCL; MZL; MW; PCNSL. |
Documenten |
In- en exclusiecriteria |
Naam | GCT3014-01 |
Titel | An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies (DLBCL and AML) |
Status | open in UMCU (m.jak@umcutrecht.nl) ,EMC (a.broyl@erasmusmc.nl) en MUMC (janine.van.elssen@mumc.nl) |
Medicatie | HexaBody®-CD38 |
Populatie | Relapsed or refractory DLBCL, both de novo or histologically transformed and RRMM patients |
Documenten | In- en exclusiecriteria |
Naam | DALY 2-EU |
Titel | A pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL), who are not eligible for high-dose chemotherapy and autologous stem cell transplantation |
Status |
open in UMCG, Amsterdam UMC (location AMC), ErasmusMC, LUMC |
Medicatie | anti-CD19/CD20 CAR-T product MB-CART2019.1 |
Populatie | relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL) Optional for SOC group: Cross-over to MB-CART2019.1 treatment (3rd line) at relapse or progression at any time within 1 year after randomization or Failure to achieve PR or CR at or beyond Week 8 after randomisation (4 cycles of R-GemOx or 3 cycles of BR plus polatuzumab vedotin) and the start of a new anti-lymphoma therapy is warranted. |
Documenten | In en exclusiecriteria Physician fact sheet |
Naam | Atalanta-1 (CP0201-NHL CellPoint) |
Titel | A phase I/II, multicenter study evaluating the feasibility, safety, and efficacy of point-of-care manufactured 19CP02 in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma |
Status | Open in Amsterdam UMC (location AMC), LUMC |
Medicatie | anti CD19 CAR-T product 19CP02 |
Populatie | Relapsed/refractory B-cell non-Hodgkin lymphoma (DLBCL, FL, MZL, MCL) |
Documenten | In en exclusiecriteria |
Naam | EPCORE NHL-2 |
Titel |
A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; |
Status | Open |
Deelnemers |
The study is open at Erasmus MC (p.lugtenburg@erasmusmc.nl; p.mutsaers@erasmusmc.nl; RNhema.ctc@erasmusmc.nl); UMCG (m.nijland@umcg.nl) LUMC (j.s.p.vermaat@lumc.nl); MUMC (marjolein.vander.poel@mumc.nl); VUMC (m.chamuleau@amsterdamumc.nl; hematol@amsterdamumc.nl), |
Studie info |
The study is open for arm 9 epcoritamab plus lenalidomide in rrFL POD24 |
Documenten | Subject Eligibility |
Naam | EPCORE NHL-1 |
Titel | A phase 1-2, open-label, dose-escalation and expansion trial of GEN3013 (bispecific antibody CD20xCD3, epcoritamab) in patients with relapsed, progressive or refractory B-Cell lymphoma. |
Status | Open |
Deelnemers | The study is open at Erasmus MC (p.lugtenburg@erasmusmc.nl; p.mutsaers@erasmusmc.nl; RNhema.ctc@erasmusmc.nl); VUMC (m.chamuleau@amsterdamumc.nl; hematol@amsterdamumc.nl), UMCU (r.mous@umcutrecht.nl; hemat-research@umcutrecht.nl) and MUMC (marjolein.vander.poel@mumc.nl) |
Studie info | The study is in the optimization part and only open for rr MCL. |
Documenten | In- en exclusie criteria |
Naam | R/R CLL (GCT3013-03) |
Studie title | Phase 1b/2 GEN3013 Monotherapy Study De |
Studie drug | Epcoritamab (subcutaneous CD3xCD20 |
Populatie | Relapsed Refractory CLL en richter |
Deelnemers |
Currently open in: Amsterdam UMC, AMC (a.p.kater@amsterdamumc.nl) & UMC Utrecht (R.Mous@umcutrecht.nl) |
Studie info | R/R CLL after receiving at least 2 prior lines of systemic antineoplastic therapy, including treatment with (or intolerance of) a BTK inhibitor and with active CLL disease that needs treatment per iwCLL2018. Also for Richter's Syndrome (please see in- and exclusion criteria) |
Studie docs | In- and exclusion criteria |
Planned trials
Naam | MAGNAZ |
Titel |
Een multi-center, open-label, fase II studie waarbij Zanubrutinib wordt onderzocht in combinatie met de standaardbehandeling (Rituximab of soortgelijk) bij patiënten met een MGUS (monoclonal gammopathy of unknown significance) in combinatie met anti-MAG (Myelin Associated Gycoproteine) neuropathie – MAGNAZ studie |
Status | Gepland |
Documenten | volgt |
Naam | NP39461 |
Titel | Open-label, dose escalation/expansion phase IB study to evaluate the safety, pharmacokinetics, and clinical activity of the combination of RO6870810 and venetoclax, with or without rituximab, in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). |
Status | Gepland |
Documenten | Protocol synopsis In- en exclusiecriteria |
Gesloten Studies
Naam | ZUMA-2 cohort 3 |
Titel | A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2) |
Status | Open in AUMC (AMC), EMC & UMCG |
Medicatie | KTE-X19 |
Populatie | r/r MCL BTKi-naive (i.e. Ibrutinib, Acalabrutinib) |
Documenten | Subject eligibility |
Naam | GEN3009 |
Titel |
Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma – A First-in-Human, Open-label, Phase I/IIa Dose Escalation Trial with Dose Expansion Cohorts |
Status | Closed |
Deelnemers | VUMC (m.chamuleau@amsterdamumc.nl), Utrecht, Rotterdam en Maastricht |
Documenten | In- en exclusiecriteria |
Naam |
Valentine study |
Titel | Single-Arm, Phase 2 Study of Valemetostat Tosylate Monotherapy in Subjects with Relapsed/Refractory Peripheral T-Cell Lymphoma (Valemetostat tosylate [DS-3201b], an enhancer of zeste homolog [EZH] 1/2 dual inhibitor, for R/R PTCL) |
Status | Closed |
Medicatie | Valemetostat |
Populatie | R/R PTCL and R/R ATl |
Documenten | In en exclusiecriteria |
Naam | Lym1002 |
Titel | A Phase 1b, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Combination with JNJ-67856633 in Participants with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia |
Status | Closed |
Medicatie | BTK-inhibitor i.c.m. MALT-inhibitor |
Studie info | DLBCL (> 1ste lijn; ook post CAR-T); FL (> 2de lijn; ook getransformeerd/ 3B); CLL, MCL, MZL en WM (> 2 lijn), Eerdere behandeling met BTK-i toegestaan (tenzij progressie de reden van staken was). |
Documenten | In- en Exclusie criteria |
Naam | EDO-S101-1001 |
Titel | Phase 1 study to investigate the safety, pharmacokinetic profiles and efficacy of EDO-S101 (tinostamustine), a first-in-class alkylating histone deacetylase inhibition (HDACi) fusion molecule in relapsed/refractory hematological malignancies. |
Status | Gesloten |
Deelnemers | Erasmus MC en VUMC |
Studie info | The study is in stage 2 = expansion phase and is open for: Cohort 2: rr Hodgkin lymphoma after ≥ 2 prior lines therapy Cohort 4: rr CTCL (MF; SS), ≥ 1 and ≤ 4 prior lines of systemic therapy |
Documenten | In- en Exclusie criteria |
Naam | TRANSCEND WORLD (Celgene JCAR017-BCM-001) |
Titel | A phase 2, single-arm, multi-cohort, multicenter trial to determine the efficacy and safety of JCAR017 in adult subjects with aggressive B-Cell non-Hodgkin lymphoma. |
Status | Closed |
Deelnemers | De studie is open in het Erasmus MC (p.lugtenburg@erasmusmc.nl; p.mutsaers@erasmusmc.nl; RNhema.ctc@erasmusmc.nl). |
Studie info | Open zijn nu cohort 4 (firstline therapy high grade B-cell lymphoma with MYC and BCL2 and / or BCL6 translocations) en cohort 5 (PCNSL who failed therapy with high dose chemotherapy and ASCT; no prior WBRT) Open is ook cohort 7, derdelijns poliklinische behandeling met CAR T-cells, voor zelfde indicatie als axi-cel |
Documenten | Aanvullende in- en exclusie criteria Informeer eerst of er een slot beschikbaar is voor de verschillende cohorten! |
Naam | CDK9 |
Titel | A Phase 1, Open-Label, Multicentre, Non-Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AZD4573, a Potent and Selective CDK9 Inhibitor, in Subjects with Relapsed or Refractory Haematological Malignancies. |
Status | Closed |
Deelnemers | De studie is open in het AMC en het Antonius Ziekenhuis Nieuwegein |
Documenten | Eligibility criteria |
Naam | ACT15320 |
Titel | A Phase 1/2 open-label, multi-center, safety, preliminary efficacy and pharmacokinetic (PK) study of isatuximab in combination with other anti-cancer therapies in participants with lymphoma. |
Status | Closed |
Deelnemers | MUMC |
Naam | BELINDA (CCTL019H2301) |
Titel | Tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial |
Status | Closed |
Deelnemers | AMC en UMCUtrecht |
Documenten | Flow en inclusie criteria |
Naam | TRANSFORM (Celgene JCAR017-BCM-003) |
Titel | A global randomized multicenter phase 3 trial to compare the efficacy and safety of JCAR017 (Car-T-cell) to standard of care (autologous SCT) in adult subjects with high-risk, transplant-eligible relapsed or refractory aggressive B-cell non-Hodgkin lymphomas |
Status | Closed |
Deelnemers | Erasmus MC (p.lugtenburg@erasmusmc.nl; p.mutsaers@erasmusmc.nl; RNhema.ctc@erasmusmc.nl) |
Documenten | In- en exclusie criteria |
Naam | Harbour |
Studie title | Phase 1b study with blinatumumab in combination with pembrolizumab treatment in 3th line DLBCL |
Status | Closed |
Deelnemers | The study is open at Erasmus MC (p.lugtenburg@erasmusmc.nl; p.mutsaers@erasmusmc.nl; RNhema.ctc@erasmusmc.nl); MUMC (marjolein.vander.poel@mumc.nl) and Radboudumc (wendy.stevens@radboudumc.nl) |
Studie info | The study is on hold in the dose escalation phase. The dose expansion phase will probably start 01-01-2021 |
Studie docs | In- and exclusion criteria |