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

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)
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

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 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)
Naam Aclarubicine
Fase fase 3
Therapie acarubicine +LDC
Doelstellingen Eficacy
Populatie R/R AML
Eligibility pre and post-allo-Tx
Status gepland Q1 2021
Deelnemers ErasmusMC, UMCG, AmsterdamUMC, LUMC