Leukemia Associated studies

 

Please find below an overview of non-HOVON trials (phase 1/2) that are open in the Netherlands

Overview phase 1/2 studies


Open trials

Short name Sanofi TCD17197
Phase  Phase 1/2
Therapy SAR443579 is a bispecific NK cell and CD123-engager
Objectives MTD, Safety, RP2D
Population R/R AML, MDS IPSS-R interim/high, B-ALL (CD123 pos)
Eligibility pre- and post allo-Tx
Status open (slots)
Participants ErasmusMC (Jongen-Lavrencic), UMCG (Huls) UMC Amsterdam (de Leeuw)
Short name GSK3745417
Phase Phase I (escalation/expansion)
Therapy STING (STimulator of Interferon Genes) agonist
Objectives MTD, Safety, RP2D
Population R/R AML, MDS IPSS-R interim/high
Eligibility pre- and post allo-Tx
Status open (slots)
Participants ErasmusMC (Jongen-Lavrencic)
Short name Ellipses
Phase Phase I/IIA
Therapy dual FLT-3 and Aurora Kinase oral inibitor
Objectives MTD, Safety
Population R/R AML
Eligibility pre- and post allo-Tx
Status open
Participants ErasmusMC (Jongen-Lavencic) VUMC (Janssen) UMCG (Huls)
Short name SGNS70-101 AML
Phase Phase I
Therapy anti-CD70 Moab SEA-CD70
Objectives Safety
Population R/R MDS R/R AML
Eligibility not after alloSCT
Status open ca. NOV 2021
Participants UMCU (v Rhenen)
Short name R/R B-ALL blina and PD1 remmer
Title 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)
Phase Phase 1b
Therapy Administration of Blinatumomab in Combination With AMG 404
Objectives Safety, Tolerability, Pharmacokinetics and Efficacy
Population Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)
Inclusion 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 
Reference Clinicaltrials.gov
Participants UMCG (Dr. M. Bellido)
Short name NK4AML
Title Administration of ex vivo generated allogeneic natural killer cells in combination with subcutaneous IL-2 in patients with AML
Phase Phase I/IIa
Therapy Cy/Flu + NK cells with and without subcutaneous IL-2 (phase 1 ramp up dose IL-2)
Objectives Safety and clinical efficacy
Population AML or MDS EB-2 with stable or non-rapidly progressive disease without or with disease inhibitory medication
Eligibility

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

Status Open
Reference Clinicaltrials.gov: NCT04347616
Participants Radboudumc (Dr. N.P.M. Schaap, Dr. M. Roeven): www.radboudumc.nl/nk4aml
Study docs Synopsis
Short name FLAMSA-TCD-RIC met sequentieel DLI on d90 en d180 (investigator initiated, non-industrial)
Phase Phase 2
Therapy FLAMSA-TCD-RIC-allo-Tx with DLI singel arm
Objectives Safety (to reach DLI and NRM)
Population age 60-75 years primary refractory and relaps AML and high risk MDS
Eligibility pre-allo-Tx
Status open
Participants LUCM (Veelken)
Short name TEG001 cells in R/R AML/MDS
Phase Phase 1
Therapy TEG001 cells (T cells transdced with a gamma/delta TCR)
Objectives MTD/Safety
Population R/R AML; MDS; MM
Eligibility RR
Status open
Participants UMCU (De witte)
Short name DCOne-002
Study title 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
Participants AmsterdamUMC - VUmc, Prof. Dr. A.A. van de Loosdrecht
UMC Groningen, Prof. Dr. G. Huls
Study docs Protocol
Eligibility criteria

Pending trials

Short name VenCell UniCAR (UC02-123-01)
Phase Phase 1 (escalation/expansion)
Therapy UniCAR02-T-CD123 in combination with a recombinant antibody derivative (TM123)
Objectives MTD, Safety, RP2D
Population R/R AML
Eligibility pre- and post allo-Tx
Status pending
Participants ErasmusMC (Jongen-Lavrencic), UMCG (Huls) UMC Amsterdam (de Leeuw)
Short name Molecular Partners MP0533
Phase Phase 1 (escalation/expansion)
Therapy MP0533 A multispecific CD3 x CD33 x CD123 x CD70 DARPin
Objectives MTD, Safety, RP2D
Population R/R AML and MDS-EB2
Eligibility pre- and post allo-Tx
Status pending
Participants ErasmusMC (Jongen-Lavrencic), UMCG (Huls) UMC Amsterdam (de Leeuw)
Short name Biomea Fusion BMF-219
Phase Phase 1 (escalation/expansion)
Therapy BMF-219, Menin inhibitor
Objectives MTD, Safety, RP2D
Population R/R AML R/R B-ALL, DLBCL, MM
Eligibility pre- and post allo-Tx
Status pending
Participants ErasmusMC (Jongen-Lavrencic), UMCG (Huls) UMC Amsterdam (de Leeuw)
Short name MCL-1 inhibitor
Phase Phase 1
Treatment S6431 single compound
Objectives MTD, Safety
Population R/R AML and MDS
Eligibility R/R
Status pending
participants UMCU (Rhenen)


 

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