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 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 (Schaap, Roeven): www.radboudumc.nl/nk4aml
Short name AG-120 (Ivosidenib) vs Placebo icm 5-aza (AILE study Agios)
Phase Phase 3
Therapy AG-120 (Ivosidenib) or placebo in comb with with 5-aza)
Objectives OS
Population 1st line AML frail IDH1R mutation
Eligibility unfit up-front
Status open
Participants UMCU (Rhenen), UMCG (Huls)
Short name BiTE (Bispecific T Cell Engager) CD33xCD3 AMG 330 (Amgen)
Phase Phase 1
Therapy AMG 330 i.v. single agent
Objectives MTD, Safety
Population R/R AML
Eligibility pre- and post allo-Tx
Status open
Participants  ErasmusMC (Jongen-Lavencic + Lowenberg) VUMC (Ossenkoppele)
Short name MCL-117 bispecific Mab (CD3xCLEC12A) (Merus)
Phase Phase 1
Therapy MCL-117 i.v single agent
Objectives MTD, Safety
Population R/R AML and unfit elderly upfront
Eligibility pre- BUT NOT post- allo-Tx
Status open
Participants AmsterdamUMC - VUMC (Ossenkoppele), ErasmusMC (Jongen-Lavrencic, Löwenberg), UMCG (Huls)
Short name DART (Dual Affinity Re-Targeting bi-specific antibody) CD123 x CD3 (MacroGenics)
Phase Phase 1
Therapy MGD006-01 i.v. single agent
Objectives MTD, Safety
Population R/R AML and high-risk MDS
Eligibility pre- BUT NOT post-allo-Tx
Status open
Participants ErasmusMC (Jongen-Lavrencic, Löwenberg), UMCG (Huls)
Short name TEG-1 (autologous alfa beta T cells Engineerd to express a defined Gamma delta T cell receptor)
Phase Phase 1
Therapy TEG001 infusion
Objectives Safety
Population R/R AML
Eligibility pre and post-allo-Tx
Status open
Participants UMCU (De Witte, Rhenen)
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
Participangs 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
Short name M18-803 T-PLL
Study title A Prospective, Open-Label, Single-Arm, Phase 2, Multicenter Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects with T-Cell Prolymphocytic Leukemia
Reference Clinicaltrials.gov: NCT03873493
Status Open
Participants M. Bellido, Universitair Medisch Centrum, Groningen; m.bellido@umcg.nl
L. Tick, Maxima Medisch Centrum, Eindhoven; l.Tick@mmc.nl
Study docs Eligibility criteria
Short name ACE-CL-311
Study title A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination with Venetoclax with and without Obinutuzumab Compared to Investigator’s Choice of Chemoimmunotherapy in Subjects with Previously Untreated Chronic Lymphocytic Leukemia Without del(17p) or TP53 Mutation.
Reference Clinicaltrials.gov: NCT04008706
Status Open
Participants AmsterdamUMC - location AMC – Arnon Kater
Flevoziekenhuis – Koen de Heer
Study docs Flow + Eligibility criteria
Short name ACE-CL-312
Study title A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects with Chronic Lymphocytic Leukemia
Reference Clinicaltrials.gov: NCT04008706
Status Open only for patients with prior BTKi therapy (Cohort3) (Other cohorts: Treatment-naive patients and enrollment of patients with Relapsed/Refractory disease are complete)
Participants Open in:
Universitair Medisch Centrum Utrecht (Utrecht) Rogier Mous (r.mous@umcutrecht.nl)
Will also be opened in:
Albert Schweitzer Ziekenhuis (Dordrecht), Mark-David Levin
HagaZiekenhuis (Den Haag), Sabina Kersting
Rijnstate Ziekenhuis (Arnhem) Ellen vd Spek
Isala Klinieken (Zwolle), Ellen Dompeling
Study docs Flow + Eligibility criteria

Pending trials

Short name Aclarubicine
phase Phase 3
Therapy acarubicine +LDC
Objectives Eficacy
Population R/R AML
Eligibility pre and post-allo-Tx
Status pending Q1 2021
Participants ErasmusMC, UMCG, AmsterdamUMC, LUMC
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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