LLPC Associated studies
Open studies
| 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 |
| 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 April 2022 in AMC. |
| 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 | 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 (AMC), EMC & UMCG |
| Medication | KTE-X19 |
| Population | r/r MCL BTKi-naive (i.e. Ibrutinib, Acalabrutinib) |
| Study docs | Subject eligibility |
| 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 rr FL in second line POD24 patients. |
| 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 |
| Status | Open |
| Participants |
Open in VUMC (m.chamuleau@amsterdamumc.nl) |
| Study docs | In en exclusiecriteria |
| 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 open for rrDLBCL; rrFL grade 1-3a and 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) |
| Participants |
Currently open in: Amsterdam UMC, AMC |
| 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 | 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 |