Leukemie geassocieerde studies

 

Hieronder vindt u een overzicht van niet-HOVON-onderzoeken (fase 1/2) die in Nederland open zijn

Overzicht fase 1/2 studies


Open studies

Name Sanofi TCD17197
Fase Phase 1/2
Therapie SAR443579 is a bispecific NK cell and CD123-engager
Doelstellingen MTD, Safety, RP2D
Populatie R/R AML, MDS IPSS-R interm/high, B-ALL (CD123 pos)
Eligibility pre- and post allo-Tx
Status open (slots)
Deelnemers ErasmusMC (Jongen-Lavrencic), UMCG (Huls) UMC Amsterdam (de Leeuw)
Naam GSK3745417
Fase Phase 1 (escalation/expansion)
Therapie STING (STimulator of Interferon Genes) agonist
Doelstellingen MTD, Safety, RP2D
Populatie R/R AML, MDS IPSS-R interm/high,
Eligibility pre- and post allo-Tx
Status open (slots)
Deelnemers ErasmusMC (Jongen-Lavrencic)
Naam Ellipses
Fase fase I/IIA
Therapie dual FLT-3 and Aurora Kinase oraal inhibitor
Doelstellingen MTD, Safety
Populatie R/R AML
Eligibility pre- and post allo-Tx
Status open
Deelnemers ErasmusMC (Jongen-Lavrencic) VUMC (Janssen) UMCG (Huls)
Naam SGNS70-101 AML
Fase fase I
Therapie anti-CD70 Moab SEA-SD70
Doelstellingen Safety
Populatie R/R MDS R/R AML
Eligibility niet na alloSCT
Status open ca NOV 2021
Deelnemers UMCU (v. Rhenen)
Naam R/R B-ALL blina en PD1 remmer
Titel A Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)
Fase Fase 1b
Therapie Administration of Blinatumomab in Combination With AMG 404
Doelstellingen Safety, Tolerability, Pharmacokinetics and Efficacy
Populatie Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)
Inclusie criteria Age ≥ 18 years at enrollment.
Subjects with B-precursor ALL, with any of the following:
● Refractory to primary induction or refractory to salvage therapy.
● In untreated first, second or greater relapse or refractory relapse or relapse after salvage therapy
● Relapse at any time after allogeneic HSCT
– Relapse is defined as achievement of CR (CR1) during upfront therapy then relapse during or after continuation therapy.
– Refractory disease is defined as the absence of CR after standard induction therapy.
– Refractory relapse lack of CR after first salvage therapy
– Second relapse or later relapse defined as relapse after achieving a second CR (CR2) in first or later salvage.
Greater than or equal to 5% blasts in the BM.
Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2.
Subjects with relapsed or refractory B Cell ALL Ph+ disease and that are intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.
Status Open
Referentie Clinicaltrials.gov
Deelnemers UMCG (Dr. M. Bellido)
Naam NK4AML
Titel Toediening van ex vivo-gegenereerde allogene natural killer cellen in combinatie met subcutane IL-2 in patiënten met AML
Fase Fase I/IIa
Therapie  Cy/Flu + NK cellen met en zonder subcutaan IL-2 (fase 1 oplopende dosis IL-2)
Doelstellingen Veiligheid en Klinische effectiviteit
Populatie AML of MDS EB-2 met stabiele of niet-snel progressieve ziekte zonder of met ziekte remmende medicatie
Eligibility

Newly diagnosed or Relapsed/Refractory AML:
Eligibility criteria in protocol

Status Open
Referentie Clinicaltrials.gov: NCT04347616
Deelnemers Radboudumc (Dr. N.P.M. Schaap, Dr. M. Roeven): www.radboudumc.nl/nk4aml
Documenten Synopsis
Naam FLAMSA-TCD-RIC met sequentieel DLI on d90 en d180 (investigator initiated, non-industrial)
Fase Fase 2
Therapie FLAMSA-TCD-RIC-allo-Tx with DLI singel arm
Doelstelling Safety (to reach DLI and NRM)
Populatie age 60-75 years primary refractory and relaps AML and high risk MDS
Eligibility pre-allo-Tx
Status open
Deelnemers LUMC (Veelken)
Naam TEG001 cells in R/R AML/MDS
Fase Fase 1
Therapie TEG001 cells (T cells transdced with a gamma/delta TCR)
Doelstelling MTD/Safety
Populatie R/R AML; MDS; MM
Eligibility RR
Status open
Deelnemers UMCU (De Witte)
Naam DCOne-002
Titel An international, multicentre open-label study to evaluate the efficacy and safety of two different vaccination regimens of immunotherapy with allogeneic dendritic cells, dcp-001, in patients with acute myeloid leukaemia that are in remission with persistent mrd
Status Open
Deelnemers AmsterdamUMC - VUmc, Prof. Dr. A.A. van de Loosdrecht
UMC Groningen, Prof. Dr. G. Huls
Documenten Protocol
In- en exclusiecriteria

Geplande studies

Naam VenCell UniCAR (UC02-123-01)
Fase Phase 1 (escalation/expansion)
Therapie UniCAR02-T-CD123 in combination with a recombinant antibody derivative (TM123)
Doelstellingen MTD, Safety, RP2D
Populatie R/R AML
Eligibility pre- and post allo-Tx
Status pending
Deelnemers ErasmusMC (Jongen-Lavrencic), UMCG (Huls) UMC Amsterdam (de Leeuw)
Naam Molecular Partners MP0533
Fase Phase 1 (escalation/expansion)
Therapie MP0533 A multispecific CD3 x CD33 x CD123 x CD70 DARPin
Doelstellingen MTD, Safety, RP2D
Populatie R/R AML and MDS-EB2
Eligibility pre- and post allo-Tx
Status pending
Deelnemers ErasmusMC (Jongen-Lavrencic), UMCG (Huls) UMC Amsterdam (de Leeuw)
Naam Biomea Fusion BMF-219
Fase Phase 1 (escalation/expansion)
Therapie BMF-219, Menin inhibitor
Doelstellingen MTD, Safety, RP2D
Populatie R/R AML R/R B-ALL, DLBCL, MM
Eligibility pre- and post allo-Tx
Status pending
Deelnemers ErasmusMC (Jongen-Lavrencic), UMCG (Huls) UMC Amsterdam (de Leeuw)
Naam MCL-1 inihibitor
Fase Fase 1
Therapie S6431 single compund
Doelstellingen MTD, Safety
Populatie R/R AML abd MDS
Eligibility R/R
Status Gepland
Deelnemers UMCU (Rhenen)


 

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