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:
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
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.
- Additional eligibility criteria in protocol.

Status Open for dose level 3, limited slots available
Participants UMC Utrecht (Dr. L.E. van der Wagen)
Study docs

Protocol synopsis
In- exclusion criteria 

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
Part G

Eligibility

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

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:
Eligibility criteria in protocol

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
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