Leukemia Associated studies
Please find below an overview of non-HOVON trials (phase 1/2) that are open in the Netherlands
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), Radboudumc (Langemeijer) |
| 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: |
| 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) |