Leukemie geassocieerde studies
Open studies
| Naam | Low-dose melphalan in R/R AML or MDS EB |
| Titel | 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 |
| Fase | Phase II |
| Therapie | Low-dose oral melphalan, 56 days with 2 mg tablet x 1 |
| Doelstellingen | Best Objective Responses (Phase II), side effects, clinicobiological features, response mechanisms |
| Populatie | Adults with R/R AML or MDS EB without unfavourable cytogenetics |
| Eligibility |
Inclusion criteria: |
| Status | Open September 2023 |
| Deelnemers | Norwegian hospitals: Participating hospitals - IMPRESSNorway |
| Referentie | Study Details | NCT04817956 | Improving Public Cancer Care by Implementing Precision Medicine in Norway | ClinicalTrials.gov |
| Documenten | Contact - IMPRESSNorway |
| 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 |
| Documenten |
| 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 |
| 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 | 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 | 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 | 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 | Open |
| Deelnemers | UMCG, ErasmusMC (Jongen-Lavencic), AmsterdamUMC (de Leeuw) |
| 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 |