LLPC Associated studies

Open studies

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 Open
Participants

Open in VUMC (m.chamuleau@amsterdamumc.nl)
Opening soon in Utrecht, Rotterdam  en Maastricht

Study docs In en exclusiecriteria

 

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 Open
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)
Study docs

Additional inclusion and exclusion criteria
Please inform first if a slot is available for the different cohorts!

 

Short name GCT3013-01
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 expansion phase. Patients with relapse or refractory aggressive B-NHL (DLBCL, HGBCL (DH/TH), PMBCL, Follicular lymphoma grade 3B) or Follicular lymphoma (grade 1-3A) or mantle cell lymphoma may be included, after at least 2 prior lines of therapy. For aggressive B-NHL ask for a slot reservation! For FL and MCL this is not necessary.
Study docs  In- and exclusion criteria
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 Open
Participants The study is open in AMC and the Antonius Hospital Nieuwegein
Study docs Eligibility 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 Open
Particpants

The study is open at Erasmus MC (p.lugtenburg@erasmusmc.nl; p.mutsaers@erasmusmc.nl;
researchverpleegkundigehematologie@erasmusmc.nl) and VUMC (j.zijlstra@amsterdamumc.nl; hematol@amsterdamumc.nl).
The study will also open at LUMC

Study info

The study is in stage 2 = expansion phase and is open for:
Cohort 2: rr Hodgkin lymphoma after ≥ 3 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 R/R CLL
Study title Phase 1b/2 GEN3013 Monotherapy Study Design
Study drug Epcoritamab (subcutaneous CD3xCD20)
Participants

Currently open in: Amsterdam UMC, AMC
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
Study docs In- and exclusion criteria

Planned trials

 

Short name CMAK638X2101
Study title A phase I/II, multicenter, open-label study of MAK683 in adult patients with advanced malignancies, hematological malignancies include relapsed or refractory DLBCL or FL with or without EZH2 mutation and relapsed or refractory T-cell lymphoma
Status Planned

 

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
Short name GCT3013-02
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 planned
Participants The study will open at Erasmus MC (p.lugtenburg@erasmusmc.nl; p.mutsaers@erasmusmc.nl; RNhema.ctc@erasmusmc.nl); MUMC (marjolein.vander.poel@mumc.nl); VUMC (m.chamuleau@amsterdamumc.nlhematol@amsterdamumc.nl), UMCU (r.mous@umcutrecht.nl; hemat-research@umcutrecht.nl) and LUMC (j.s.p.vermaat@lumc.nl)
Study info

Cohort 1 DLBCL epcoritamab plus R-CHOP
Cohort 2 rr FL epcoritamab plus lenalidomide-rituximab
The study will start in December 2020/January 2021

Study docs  

Closed Studies

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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