Clinical trial • Phase II • Haematology

Azacitidine for Myelodysplastic syndrome|Mixed myelodysplastic/myeloproliferative neoplasm|Acute myeloid leukemia

Phase II trial of Azacitidine for Myelodysplastic syndrome|Mixed myelodysplastic/myeloproliferative neoplasm|Acute myeloid leukemia.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Myelodysplastic syndrome|Mixed myelodysplastic/myeloproliferative neoplasm|Acute myeloid leukemia
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
13-02-2024
First CTIS Authorization Date
15-03-2024

Trial design

open-label, none/not specified-controlled Phase II trial across 12 sites in Norway, Finland, Denmark and others.

Open Label
Yes
Comparator
None/Not specified
Biomarker Stratified
True, biomarker: minimal residual disease (MRD); strata: MRD-positive cohort and whole study cohort
Target Sample Size
200
Trial Duration For Participant
630

Eligibility

Recruits 200 Vulnerable population selected; signed informed consent required. No further details on assent or specific consent handling are provided in the available JSON..

Pregnancy Exclusion
All female subjects of childbearing potential have to have negative pregnancy test within 2 weeks prior to inclusion to the study
Vulnerable Population
Vulnerable population selected; signed informed consent required. No further details on assent or specific consent handling are provided in the available JSON.

Inclusion criteria

  • {"criterion_text":"- Signed informed consent\n- Age ≥ 18 years\n- Subjects eligible for stem cell transplantation\n- Subjects having the disease myelodysplastic syndrome, mixed myelodysplastic/myeloproliferative syndrome or acute myeloid leukemia (AML) with myelodysplasia related dysplasia and 20-29% marrow blasts\n- All female subjects of childbearing potential have to have negative pregnancy test within 2 weeks prior to inclusion to the study"}

Exclusion criteria

  • {"criterion_text":"- No traceable genetic aberration identified either in screening next generation sequencing panel or next generation sequencing panel performed at diagnosis\n- Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders\n- Mental inability, reluctance or language difficulties that results in difficulty understanding the meaning of study participation"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The percentage of clinical events defined as relapse or non-relapse death at 12 months from verified MRD positivity (NMDSG14B Part 2 compared to Part 1)","definition_or_measurement_approach":"Percentage of clinical events (relapse or non-relapse death) occurring within 12 months from verified MRD positivity, comparing NMDSG14B Part 2 to Part 1."}

Secondary endpoints

  • {"endpoint_text":"- MRD positive cohort: Relapse-free survival\n- MRD positive cohort: GVHD and relapse-free survival\n- MRD positive cohort: Proportion of MRD positive subjects achieving MRD-negativity\n- MRD positive cohort: Incidence and severity of GVHD\n- MRD positive cohort: Safety in MRD positive subjects subjected to MRD-guided clinical intervention\n- Whole study cohort: Relapse-free survival\n- Whole study cohort: GVHD and relapse-free survival\n- Whole study cohort: Incidence and severity of GVHD\n- Whole study cohort: Overall survival","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
200
Recruitment Window Months
48
Consent Approach
Signed informed consent required from participants; minimum age ≥ 18 years. No further details on assent, age-specific documents, or languages available are provided in the available JSON.

Geography

Total Number Of Sites
12
Total Number Of Participants
200

Norway

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
20-03-2024
Processing Time Days
16
Number Of Sites
2
Number Of Participants
50

Sites

Site Name
Helse Bergen HF
Department Name
Hematology
Contact Person Name
Astrid Olsnes Kittang
Contact Person Email
astrid.olsnes.kittang@uib.no
Site Name
Oslo University Hospital HF
Department Name
Hematology
Contact Person Name
Tor Henrik Anderson Tvedt
Contact Person Email
totved@ous-hf.no

Finland

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
15-03-2024
Processing Time Days
11
Number Of Sites
1
Number Of Participants
25

Sites

Site Name
HUS-Yhtymae
Department Name
Hematology
Contact Person Name
Urpu Salmenniemi
Contact Person Email
urpu.salmenniemi@hus.fi

Denmark

Earliest CTIS Part Ii Submission Date
16-12-2024
Latest Decision Or Authorization Date
07-01-2025
Processing Time Days
22
Number Of Sites
2
Number Of Participants
25

Sites

Site Name
Rigshospitalet
Department Name
Hematology
Contact Person Name
Lone Smidstrup Friis
Site Name
Aarhus University Hospital
Department Name
Clinical Medicine
Contact Person Name
Gitte Olesen
Contact Person Email
gitolese@rm.dk

Sweden

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
15-03-2024
Processing Time Days
11
Number Of Sites
7
Number Of Participants
100

Sites

Site Name
Norrlands University Hospital
Department Name
Hematology
Contact Person Name
Johannes Bålfors
Site Name
Linkoping University Hospital Region Ostergotland
Department Name
Hematology
Contact Person Name
Petter Willner Hjelm
Site Name
Uppsala University Hospital
Department Name
Hematology
Contact Person Name
Elisabeth Ejerblad
Site Name
Karolinska University Hospital
Department Name
Hematology
Contact Person Name
Andreas Björklund
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Hematology
Contact Person Name
Lena von Bahr
Contact Person Email
lena.von.bahr@vgregion.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Hematology
Contact Person Name
Lars Nilsson
Contact Person Email
lars.nilsson@skane.se
Site Name
Daniel Naezens Vag
Department Name
Hematology

Sponsor

Primary sponsor

Full Name
Karolinska University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
AZACITIDINE
Active Substance
Azacitidine
Modality
Small molecule
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Authorised
Maximum Dose
75 mg/m2

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