Leukemie geassocieerde studies
Hieronder vindt u een overzicht van niet-HOVON-onderzoeken (fase 1/2) die in Nederland open zijn
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), Radboudumc (Langemeijer) |
| 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: |
| 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) |