Leukemie geassocieerde studies

 

Open studies

Naam Syndax
Titel 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
Fase Fase I
Therapie Intensive chemo and revumenib
Doelstellingen MTD, safety, tolerability, feasibility, efficacy, kinetics, persistence
Populatie Adults with untreated AML with NPM1, KMT2A and NUP98 alterations
Eligibility Local testing
Status Open
Deelnemers UMC Utrecht (Dr. A. van Rhenen)
Documenten Inclusie criteria
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:
a) DDX41 mutated myeloid neoplasia
OR
b) High-risk MDS or AML according to WHO 2016 criteria with low (<30%) or normal (30-50%) bone marrow cellularity
Exclusion criteria:
a) High mutated TP53 allelle frequency (>20%).
b) The occurrence of more than two cytogenetic aberrations or chromosome 7 aberrations, for the patients fulfilling inclusion criteria b)
c) Any GI disorder that may affect absorption of oral medications, such as mal-absorption syndrome or status post-major bowel resection
d) History of hypersensitivity to any of the additives in the melphalan drug formulation 
e) Breast-feeding women.

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

Protocol synopsis
In- en exclusiecriteria

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
- Aanvullende in- en exclusiecriteria in protocol.

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
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
Titel 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.
Fase Fase I 
Therapie Azacitidine +/- SEA-CD70 for higher risk MDS part E; Venetoclax-azacitidine + SEA-CD70 for AML part G
Doelstellingen Safety
Populatie

Part E
Part G

Eligibility

Age ≥18 years.
ECOG Performance status of 0–2.

Status open
Deelnemers UMCU (v. Rhenen)
Documenten SGN-part E and G
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:
Eligibility criteria in protocol

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 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 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


 

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