LLPC geassocieerde studies

Open studies

Naam	ZUMA 23
Titel	KT-US-484-0136: An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel versus Standard of Care Therapy as First-Line Therapy in Subjects with High-Risk Large B-Cell Lymphoma.
Status	Open in Amsterdam UMC, UMCG, UMCU, LUMC, MUMC
Populatie	Nieuwe diagnose DLBCL (mag getransformeerd) met IPI 4 of 5. Mag na 1 kuur R-CHOP ook nog geincludeerd worden.

Naam	Athena-1 (Regeneron)
Titel	A Phase 1 Study to Assess Safety and Tolerability of REGN5837, an Anti-CD22 X anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination with Odronextamab, an Anti-CD20 X Anti-CD3 Bispecific Monoclonal Antibody, in Patients with Aggressive B-Cell Non-Hodgkin Lymphomas (ATHENA-1)
Status	Open in Erasmus MC and Amsterdam UMC
Medicatie	Odronextamab combined with REGN5837
Populatie	Relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (DLBCL) after two lines including CAR T-cell therapy
Documenten	In en exclusiecriteria

Naam	OLYMPIA-4
Titel	A Phase 3, Randomized, Open Label Study Evaluating the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 x Anti-CD3 Bispecific Antibody, versus Standard of Care Therapy in Participants with Relapsed/Refractory Aggressive B-cell non[1]Hodgkin Lymphoma (OLYMPIA-4)
Status	Open in het ErasmusMC (Mutsaers)
Medicatie	Odronextamab versus Standard of Care (ASCT)
Populatie	DLBCL, not otherwise specified (de novo or transformed indolent NHL), high-grade B-cell lymphoma with MYC and BCL2 ± BCL6 rearrangements with diffuse LBCL histology (DHL/THL), PMBCL, T/HRBCL, or FL3b. Primary refractory or relapse ≤ 12 months from initiation of frontline therapy. Transplant eligible.
Study docs	In- en exclusie criteria

Naam	CD19/CD20 biCAR
Titel	Phase 1b Multicenter, Open-label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Status	Open in UMCU & EMC
Medicatie	JNJ-90014496 Autologous CD19/CD20 Bi-specific CAR-T
Populatie	2 cohorten: Cohort 1: R/R DLBCL of Folliculair lymfoom gr3b na 2 lijnen systeemtherapie of na 1 lijn systeemtherapie in transplant-ineligible patienten. Cohort voor CART-exposed patienten is voorlopig dicht. Cohort 2: Folliculair lymfoom gr 1-3a en marginale zone lymfoom na 2 of meer lijnen systeemtherapie (inclusief een anti CD20 antilichaam) - open
Study docs	In- and exclusion criteria

Naam	Magnaz
Titel	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
Medicatie	Rituximab (4 maal) als standaardbehandeling, gecombineerd met 6 tot 12 mnd zanubrutinib
Populatie	patienten met IgM MGIS en anti MAG polyneuropathie
Study docs	In- and exclusion criteria

Naam	CA1231000
Titel	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)
Medicatie	BMS-986458; BCl6 degrader
Populatie	relapsed/refractory DLBCL and FL
Study docs	In- en exclusiecriteria

Naam	KT-US-499-0150
Titel	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)
Medicatie	KITE-363; Autologous anti-CD19/CD20 chimeric antigen receptor [CAR] T-cell product
Populatie	Relapsed and/or Refractory B-cell Lymphoma
Study info	Study informatie
Documenten	In- en exclusie criteria

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); Part 2 (expansion): To evaluate the objective tumor response rate (ORR).
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) and RadboudUMC (W. Stevens), UMCU (Utrecht) (R.Mous), UMCG (Groningen) (M.Nijland)
Medicatie	BTK-degrader (oral)
Populatie	R/R CLL/SLL; DLBCL; tFL; Richter; high-grade B-cell lymphoma; FL; MCL; MZL; MW; PCNSL. Voor alle indicaties tenminste 2 eerdere behandellijnen. Uitzondering: PCNSL kan geincludeerd worden na 1 eerdere behandellijn.
Documenten	In- en exclusiecriteria Advertentie tekst (goedgekeurd door EC)

Naam	Atalanta-1 (CP0201-NHL)
Titel	Een fase I/II multicenterstudie ter evaluatie van de haalbaarheid, veiligheid en werkzaamheid van op point-of-care geproduceerde GLPG5101 (19CP02) bij patiënten met recidiverend of refractair B-cel non-Hodgkinlymfoom
Status	Open in Amsterdam UMC (location AMC), LUMC
Medicatie	anti CD19 CAR-T product GLPG5101
Populatie	Relapsed/refractory B-cell non-Hodgkin lymphoma; DLBCL (ook met CZS-lokalisatie), Richterse Transformatie, MCL, BL en PCNSL (FL en MZL cohorten zijn helaas vol)
Documenten	In en exclusiecriteria

M22-132

GCT3014-01

R/R CLL (GCT3013-03)

DALY 2-EU

EPCORE NHL-2

ZUMA-2 cohort 3

GEN3009

Valentine study

Lym1002

EDO-S101-1001

TRANSCEND WORLD (Celgene JCAR017-BCM-001)

CDK9

ACT15320

BELINDA (CCTL019H2301)

TRANSFORM (Celgene JCAR017-BCM-003)

Harbour