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LLPC geassocieerde studies

Open studies

 

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)
Medicatie BTK-degrader (oral)
Populatie

Relapsed/Refractory B-Cell Malignancies
Phase 1a: CLL/SLL, DLBCL, FL, MCL, MZL, or WM who have received at least 2 prior systemic therapies (1 prior therapy for WM), and for whom no other therapies are known to provide clinical benefit.
Phase 1b: Same as Phase 1a with addition of primary central nervous system lymphoma or secondary central nervous system involvement with disease progression on 1 prior therapy.
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
planned in LUMC
Medicatie anti-CD19/CD20 CAR-T product MB-CART2019.1
Populatie relapsed/refractory diffuse large B-cell lymphoma (R-R DLBCL)
Documenten In en exclusiecriteria
Studie overzicht
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 April in AMC
Medicatie anti CD19 CAR-T product 19CP02
Populatie Relapsed/refractory B-cell non-Hodgkin lymphoma (DLBCL, FL, MZL, MCL)
Documenten In en exclusiecriteria
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 EPCORE NHL-2
Titel

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
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), 
UMCU (r.mous@umcutrecht.nl) 
Studie info

De studie is open voor arm 9 rr FL in second line POD24 patients.
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 Open
Deelnemers Open in VUMC (m.chamuleau@amsterdamumc.nl)
Gaat ook open in Utrecht, Rotterdam  en Maastricht
Documenten In en exclusiecriteria
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 open for rrDLBCL; rrFL grade 1-3a and 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
Deelnemers

Currently open in: Amsterdam UMC, AMC
Will be opened at: Universitair Medisch Centrum Groningen,  Maastricht University Medical Center & UMC Utrecht
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 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 Cloesed
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
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