LLPC Associated studies

Open studies

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);
Part 2 (expansion): To evaluate the objective tumor response rate (ORR).

Study docs

In- and exclusion criteria

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)
Medication BTK-degrader (oral)
Population

R/R CLL/SLL; DLBCL; tFL; Richter; high-grade B-cell lymphoma; FL; MCL; MZL; MW; PCNSL
For all indications at least 2 prior therapies. Exception: PCNSL can be included after 1 previous therapy. 

Study Docs

In- en exclusiecriteria
Advertentie text (approved by EC)

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

In- en exclusiecriteria

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)
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.

Study Docs

In and exclusion criteria
Physician fact sheet

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.nlhematol@amsterdamumc.nl)
UMCU (r.mous@umcutrecht.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)
Will be opened at: Universitair Medisch Centrum Groningen,  Maastricht University Medical Center 

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  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 Planned
Study docs will follow
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

 

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