Leukemie geassocieerde studies
Open studies
| Naam | MB-dNPM1-TCR.1 in R/R AML |
| Titel |
A phase I/II trial of MB-dNPM1-TCR.1 in HLA-A*02:01-positive patients with relapsed or refractory NPM1-mutated AML to determine safety and obtain first data on efficacy |
| Fase | Phase I/II |
| Therapie |
dNPM1-TCR T cells (patient-derived T cells transduced with a T cell receptor recognizing peptides from mutated NPM1 in HLA-A02 |
| Doelstellingen | MTD, Best Objective Responses (Phase II) |
| Populatie | R/R or MRD positive Npm1 mutated AML, HLA-A02 |
| Eligibility | Pre end post alloTx |
| Status | Open August 2024 |
| Deelnemers | LUMC (Dr. C.J.M.Halkes) |
| Referentie | https://clinicaltrials.gov/study/NCT06424340 |
| Study docs |
| Naam | TEG001 in patiënten met r/r AML/hoog-risico MDS of r/r MM |
| Titel | Een fase I studie naar het veiligheidsprofiel van TEG001 cel suspensie voor infusie in patiënten met recidiverende/refractaire Acute Myeloïde Leukemie/hoog risico Myelodysplastisch Syndroom (IPSS-R score >4,5) of recidiverend/refractair Multipel Myeloom. |
| Fase | Fase I |
| Therapie | TEG001 cel suspensie (T cells engineered to express a defined gamma/delta T cell receptor) |
| Doelstellingen | Maximaal getolereerde dosis, veiligheid, verdraagbaarheid, haalbaarheid, (duur) werkzaamheid, kinetiek |
| Populatie | Volwassenen met recidief/refractaire Acute Myeloïde Leukemie (AML)/hoog risico Myelodysplastisch Syndroom (MDS) (IPSS-R score >4,5) of recidief/refractair Multipel Myeloom (MM). |
| Eligibility |
Geen reguliere therapeutische behandelopties meer beschikbaar |
| Status | Open voor dosislevel 3, slots beperkt beschikbaar |
| Deelnemers | UMC Utrecht (Dr. L.E. van der Wagen) |
| Documenten | Protocol synopsis In- en exclusiecriteria |
| 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), AmsterdamUMC (de Leeuw) |
| Referentie | https://clinicaltrials.gov/study/NCT05673057 |
| 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), AmsterdamUMC (de Leeuw), Radboudumc (Langemeijer) |
| Referentie | https://clinicaltrials.gov/study/NCT05086315 |
| 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), AmsterdamUMC (de Leeuw) UMCG (Huls) |
| Referentie | https://clinicaltrials.gov/study/NCT04581512 |
| Naam | SGNS70-101 AML |
| Fase | fase I of SEA-CD70 in Myeloid Malignancies |
| Therapie | SEA-CD70 + azacitidine combination cohort in previously untreated higher-risk MDS (Parts D and E) |
| Doelstellingen | Safety |
| Populatie | R/R MDS R/R AML 1L MDS? |
| Eligibility |
Subjects with previously untreated cytologically/histologically confirmed MDS according to the 2016 WHO classification with the following |
| Status | open |
| 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 | 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 |
| Naam | AvenCell 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 | open |
| Deelnemers | ErasmusMC (Jongen-Lavrencic), UMCG (Huls), AmsterdamUMC (de Leeuw) |
| Referentie | https://clinicaltrials.gov/study/NCT04230265 |
| 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), AmsterdamUMC (de Leeuw) |
| Referentie | https://clinicaltrials.gov/study/NCT05153330 |
| Naam | BYON4413 |
| Titel | A first-in-human dose escalation and expansion trial with the antibody-drug conjugate BYON4413 to evaluate safety, pharmacokinetics, and preliminary efficacy in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic neoplasms. |
| Fase | Fase 1 |
| Therapie | Anti-CD123 tageting antibody-drug conjugate |
| Doelstellingen | Phase 1: dose finding, Phase 2: safety en preliminary efficacy |
| Populatie | Relapsed/refractory acute myeloid leukemia or myelodysplastic neoplasms (no establlished alternatives) |
| Eligibility | standaard |
| Status | Open for inclusion (slots available by predefined order, possibilty to be placed on waiting list) |
| Deelnemers | UMCG |
| Referentie | https://clinicaltrials.gov/search?intr=BYON4413 |
| Naam | Biomea Covalent-101 |
| Titel | A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF[1]219, an oral, covalent, menin inhibitor, in adult patients with acute leukemia (AL), diffuse large B-cell lymphoma (DLBCL), multiple myeloma (MM), and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) |
| Fase | Fase 1 |
| Therapie | Oral, covalent, menin inhibitor |
| Doelstellingen | Dose finding, safety, premilinary efficacy |
| Populatie | R/R acute leukemia (MLL1r [KMT2A], nucleophosmin 1 [NPM1], or other genetic mutations as specified), DLBCL, MM, or CLL/SLL, at least one SOC therapy incl. HCT |
| Eligibility | Standaard |
| Status | Open for inclusion (Enrollment slot availability as of 30Sep2024 1 Open Slot in Cohort 1 (Acute Leukemia) Sub-Cohort 2 (NPM1 only)) |
| Deelnemers | UMCG |
| Naam | AVC-201-01 |
| Titel | Multicenter, Open-label, Phase 1 Study of Allo-RevCAR01-T-CD123 Consisting of Genetically Modified T cells Carrying Reverse Chimeric Antigen Receptors (Allo-RevCAR01-T) in Combination With CD123 Target Module (R-TM123) for the Treatment of Patients With Selected Hematologic Malignancies Positive for CD123 |
| Fase | Fase 1 |
| Therapie | CAR T-cel (CD123 target module) |
| Doelstellingen | Safety, dose finding, response |
| Populatie | R/R AML with CD123+ (after or ineligible for alloHCT) |
| Eligibility | Standaard |
| Status | awaited Q4 2024 |
| Deelnemers | UMCG |
| Naam | Udance |
| Titel | Een fase I/II studie naar dendritische celvaccinatie tegen WT1 na een navelstrengbloed stamceltransplantatie in kinderen en jongvolwassenen met acute myeoloide leukemie: de U-DANCE-tegen-AML studie |
| Fase | l-ll |
| Therapie | Dendritische cell vaccinatie 3x gemaakt van cord blood donor (UCB) |
| Doelstellingen | 1) bepalen veilige dosis (2)verbeteren DFS post HCT met 20% |
| Populatie | 12-20 j oud met AML die een indicatie voor allo-hct hebben ( met UCB) |
| Eligibility | WT1 positiviteit, UCB voldoende cellen vlgs protocol |
| Status | open |
| Deelnemers | Prinses Maxima Centrum (c.a.lindemans@prinsesmaximacentrum.nl), UMC Utrecht (l.e.vanderwagen@umcutrecht.nl) |
| Referentie | Https://www.onderzoekmetmensen.nl/nl/trial/55718 |