Leukemia Associated studies

Open trials

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	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	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	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	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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