LLPC Associated studies
Open studies
| Short name | Magnaz |
| Study title | A multi-center, open-label, phase II study involving Zanubrutinib is being studied in combination with standard treatment (Rituximab or similar) in patients with MGUS (monoclonal gammopathy of unknown significance) in combination with anti-MAG (Myelin Associated Gycoprotein) neuropathy – MAGNAZ study |
| Status | Open in UMCU |
| Medication | Rituximab (4 x) as standard treatment, combined with 6 to 12 mnd zanubrutinib |
| Population | patients with IgM MGIS and anti MAG polyneuropathy |
| Study docs | In- and exclusion criteria |
| Short name | CA1231000 |
| Study title | A Phase 1/2, Multi-Center, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BMS-986458, Alone and in Combination with Anti-lymphoma Agents in Participants with Relapsed/Refractory Non-Hodgkin Lymphomas (R/R NHL) |
| Status | Open in MUMC (marjolein.vander.poel@mumc.nl) and in UMCG (m.nijland@umcg.nl) |
| Medication | BMS-986458; BCl6 degrader |
| Population | relapsed/refractory DLBCL and FL |
| study docs | In- and exclusion criteria |
| Short name | KT-US-499-0150 |
| Study title | A Phase 1 Open-label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy, in Subjects With Relapsed and/or Refractory B-cell Lymphoma |
| Status | Open in Amsterdam UMC, location VUMC (m.j.kersten@amsterdamumc.nl, ilse.kuipers@amsterdamumc.nl, hemat.trial@amsterdamumc.nl) |
| Medication | KITE-363; Autologous anti-CD19/CD20 chimeric antigen receptor [CAR] T-cell product |
| Population | Relapsed and/or Refractory B-cell Lymphoma |
| Study info | Study information |
| Study docs | In- and exclusion criteria |
| Short name | BYON4228 |
| Study title | 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, location VUMC (m.chamuleau@amsterdamumc.nl) and Nijmegen (wendy.stevens@radboudumc.nl) |
| Medication | SIRPa inhibitor |
| Population | 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); |
| Study docs |
| Short name | M22-132 |
| Study title | 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) |
| Medication | Epcoritamab (bispecific CD3xC20 antibody) |
| Population | 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 |
| Study docs | In- and exclusion criteria |
| Short name | NX-5948-301 |
| Study title |
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) and RadboudUMC (W. Stevens) and UMCU (Utrecht) (R.Mous) |
| Medication | BTK-degrader (oral) |
| Population |
R/R CLL/SLL; DLBCL; tFL; Richter; high-grade B-cell lymphoma; FL; MCL; MZL; MW; PCNSL |
| Study Docs |
|
Short name |
GCT3014-01 |
| Study title | 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) |
| Medication | HexaBody®-CD38 |
| Population | Relapsed or refractory DLBCL, both de novo or histologically transformed and RRMM patients |
| Study Docs |
| Short name | DALY 2-EU |
| Study title | 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 |
| Medication | anti-CD19/CD20 CAR-T product MB-CART2019.1 |
| Population |
relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL) |
| Study Docs |
| Short name | Atalanta-1 (CP0201-NHL Cellpoint) |
| Study title | 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 | Activated in Amsterdam UMC (location AMC), LUMC |
| Medication | anti-CD19 CAR-T product 19CP02 |
| Population | Relapsed/refractory B-cell non-Hodgkin lymphoma (DLBCL, FL, MZL, MCL) |
| Study docs | In and exclusion criteria |
| Short name | EPCORE NHL-2 |
| Study title |
A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination with Other Agents in Subjects with B-cell Non-Hodgkin Lymphoma |
| Status | Open |
| Participants |
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) |
| Study info |
The study is open for arm 9 epcoritamab plus lenalidomide in rrFL POD24 |
| Study docs | Subject Eligibility |
| Short name | EPCORE NHL-1 |
| Study title | 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 |
| Participants | 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) |
| Study info | The study is in the optimization part and only open for rr MCL. |
| Study docs | In- and exclusion criteria |
| Short name | R/R CLL (GCT3013-03) |
| Study title | Phase 1b/2 GEN3013 Monotherapy Study Design |
| Study drug | Epcoritamab (subcutaneous CD3xCD20) |
| Population | Relapsed Refractory CLL and Richter |
| Participants |
Currently open in: Amsterdam UMC, AMC (a.p.kater@amsterdamumc.nl) & UMC Utrecht (R.Mous@umcutrecht.nl) |
| Study 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). |
| Study docs | In- and exclusion criteria |
Planned trials
| Short name | NP39461 |
| Study title | 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 | Planned |
| Study docs | Protocol synopsis Eligibility criteria |
Closed Studies
| Short name | ZUMA-2 cohort |
| Study title | 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 (A MC), EMC & UMCG |
| Medication | KTE-X19 |
| Population | r/r MCL BTKi-naive (i.e. Ibrutinib, Acalabrutinib) |
| Study docs | Subject eligibility |
| Short name | GEN3009 |
| Study title | 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 |
| Participants | VUMC (m.chamuleau@amsterdamumc.nl), Utrecht, Rotterdam en Maastricht |
| Study docs | In- and exclusion criteria |
| Short name | Valentine study |
| Study title | 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 |
| Medication | Valemetostat |
| Population | R/R PTCL and R/R ATl |
| Study docs | In and exclusion criteria |
| Short name | Lym1002 |
| Study title | 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 |
| Medication | BTK-inhibitor i.c.m. MALT-inhibitor |
| Study 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). |
| Study docs | In and exclusion criteria |
| Short name | EDO-S101-1001 |
| Study title | 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 | Closed |
| Particpants | ErasmusMC and VUMC |
| Study 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 |
| Study docs | In- and exclusion criteria |
| Short name | TRANSCEND WORLD (Celgene JCAR017-BCM-001) |
| Study title | A phase 2, single-arm, multi-cohort, multicenter trial to determine the efficacy and safety of JCAR017 (CAR-T-cell) in adult subjects with aggressive B-Cell non-Hodgkin lymphoma. |
| Status | Closed |
| Participants | The study is open at Erasmus MC (p.lugtenburg@erasmusmc.nl; p.mutsaers@erasmusmc.nl; RNhema.ctc@erasmusmc.nl). |
| Study info | Now open are cohort 4 (firstline therapy high grade B-cell lymphoma with MYC and BCL2 and / or BCL6 translocations) and cohort 5 (PCNSL who failed therapy with high dose chemotherapy and ASCT; no prior WBRT) Also open is cohort 7, third line CAR T-cell therapy, given in the outpatient department, for the same indication as axi-cel. |
| Study docs | Additional inclusion and exclusion criteria Please inform first if a slot is available for the different cohorts! |
| Short name | CDK9 |
| Study title | 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 |
| Participants | The study is open in AMC and the Antonius Hospital Nieuwegein |
| Study docs | Eligibility criteria |
| Short name | ACT15320 |
| Study title | 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 |
| Participants | MUMC |
| Short name | BELINDA (CCTL019H2301) |
| Study title | 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 |
| Participants | AMC and UMCUtrecht |
| Study docs | Study flow and eligibility criteria |
| Short name | TRANSFORM (Celgene JCAR017-BCM-003 |
| Study title | 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 |
| Participants | Erasmus MC (p.lugtenburg@erasmusmc.nl; p.mutsaers@erasmusmc.nl; RNhema.ctc@erasmusmc.nl ) |
| Study docs | In- and exclusion criteria |
| Short name | Harbour |
| Study title | Phase 1b study with blinatumumab in combination with pembrolizumab treatment in 3th line DLBCL |
| Status | Closed |
| Participants | 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) |
| Study info | The study is on hold in the dose escalation phase.The dose expansion phase will probably start 01-01-2021 |
| Study docs | In- and exclusion criteria |