Leukemia Associated studies
Open trials
| Short name | Syndax |
| Title | A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific ethyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes |
| Phase | Phase I |
| Therapy | Intensive chemo and revumenib |
| Objectives | MTD, safety, tolerability, feasibility, efficacy, kinetics, persistence |
| Population | Adults with untreated AML with NPM1, KMT2A and NUP98 alterations |
| Eligibility | Local testing |
| Status | Open |
| Participants | UMC Utrecht (Dr. A. van Rhenen) |
| Study docs | Inclusion criteria |
| Short name | Low-dose melphalan in R/R AML or MDS EB |
| Title | A phase II trial of low-dose melphalan in relapse refractory AML and MDS EB with pathogenic DDX41 variants or normo/hypocellular bone marrow in the IMPRESS-Norway trial |
| Phase | Phase II |
| Therapy | Low-dose oral melphalan, 56 days with 2 mg tablet x 1 |
| Objectives | Best Objective Responses (Phase II), side effects, clinicobiological features, response mechanisms |
| Population | Adults with R/R AML or MDS EB without unfavourable cytogenetics |
| Eligibility |
Inclusion criteria: |
| Status | Open September 2023 |
| Participants | Norwegian hospitals: Participating hospitals - IMPRESSNorway |
| Reference | Study Details | NCT04817956 | Improving Public Cancer Care by Implementing Precision Medicine in Norway | ClinicalTrials.gov |
| Study docs | Contact - IMPRESSNorway |
| Short name | TEG001 in patients with r/r AML/high-risk MDS or r/r MM |
| Title | A phase I study to investigate the safety and tolerability of TEG001 cell suspension for infusion in patients with relapsed/refractory Acute Myeloid Leukemia (AML)/high-risk Myelodysplastic Syndrome (MDS) (IPSS-R > 4.5) or relapsed/refractory Multiple Myeloma (MM) |
| Phase | Phase I |
| Therapy | TEG001 cell suspension (T cells engineered to express a defined gamma/delta T cell receptor) |
| Objectives | MTD, safety, tolerability, feasibility, efficacy, kinetics, persistence |
| Population | Adults with relapsed/refractory Acute Myeloid Leukemia (AML)/high-risk Myelodysplastic Syndrome (MDS) (IPSS-R > 4.5) or relapsed/refractory Multiple Myeloma (MM) |
| Eligibility |
No remaining therapeutic treatment options available. |
| Status | Open for dose level 3, limited slots available |
| Participants | UMC Utrecht (Dr. L.E. van der Wagen) |
| Study docs |
| 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 | open |
| Participants | ErasmusMC (Jongen-Lavrencic), UMCG (Huls), AmsterdamUMC (de Leeuw) |
| Reference | https://clinicaltrials.gov/study/NCT05673057 |
| 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 | On hold |
| Participants | ErasmusMC (Jongen-Lavencic), AmsterdamUMC (de Leeuw), UMCG (Huls) |
| Reference | https://clinicaltrials.gov/study/NCT04581512 |
| Short name | SGNS70-101 AML |
| Title | This is a phase 1, open-label, multicenter, dose-finding and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and antitumor activity of SEA-CD70 monotherapy and SEA-CD70 in combination with azacitidine in adults with myeloid malignancies. |
| Phase | Phase I Study of SEA-CD70 in Myeloid Malignancies |
| Therapy | Azacitidine +/- SEA-CD70 for higher risk MDS part E; Venetoclax-azacitidine + SEA-CD70 for AML part G |
| Objectives | Safety |
| Population |
Part E |
| Eligibility |
Age ≥18 years. |
| Status | open |
| Participants | UMCU (v Rhenen) |
| Study docs | SGN-part E and G |
| 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 | BYON4413 |
| Title | 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. |
| Phase | Phase I |
| Therapy | Anti-CD123 tageting antibody-drug conjugate |
| Objectives | Phase 1: dose finding, Phase 2: safety en preliminary efficacy |
| Population | Relapsed/refractory acute myeloid leukemia or myelodysplastic neoplasms (no establlished alternatives) |
| Eligibility | Standard |
| Status | Open for inclusion (slots available by predefined order, possibilty to be placed on waiting list) |
| Participants | UMCG |
|
Reference |
https://clinicaltrials.gov/search?intr=BYON4413 |
| Short name | AVC-201-01 |
| Title | 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 |
| Phase | Phase 1 |
| Therapy | CAR T-cel (CD123 target module) |
| Objectives | Safety, dose finding, response |
| Population | R/R AML with CD123+ (after or ineligible for alloHCT) |
| Eligibilty | standard |
| Status | Open |
| Participants | UMCG, ErasmusMC (Jongen-Lavencic), AmsterdamUMC (de Leeuw) |
| Short name | Udance |
| Study title | A phase I/II post-cord blood HCT dendritic cell vaccination trial directed against WT1 for pediatric and young adult acute myeloid leukemia: the U-DANCE-anti-AML trial |
| Phase | l-ll |
| Therapy | Denditic cell vaccination 3x, md eform cord blood donor |
| Objectives | 1) determining safe dose. (2)And increasing DFS with 20% |
| Population | 12-20 j oud met AML die een indicatie voor allo-hct hebben ( met UCB) |
| Eligibility | WT1 positivity of the AML |
| Status | open |
| Participants | Prinses Maxima Centrum (c.a.lindemans@prinsesmaximacentrum.nl), UMC Utrecht (l.e.vanderwagen@umcutrecht.nl) |
| Reference | Https://www.onderzoekmetmensen.nl/nl/trial/55718 |