A study using subject-specific minimal residual disease markers to adopt treatment after allogeneic stem cell transplantation for subjects with myelodysplastic syndrome - MDS

A phase II multicenter single-armed study using subject-specific minimal residual disease markers to adopt treatment after allogeneic stem cell transplantation for subjects with myelodysplastic syndrome - MDS - MDS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-003809-22-NO

Enrollment

200

Registered

2022-08-08

Start date

2022-09-09

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic syndrome (MDS)

Interventions

Trade Name: Vidaza Product Name: Vidaza Product Code: EMEA/H/C/000978 Pharmaceutical Form: Powder for suspension for injection INN or Proposed INN: Azacitidine CAS Number: 320-67-2 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Signed informed consent Age = 18 years Subjects eligible for stem cell transplantation (SCT) Subjects having the disease MDS, mixed myelodysplastic/myeloproliferative syndrome or AML with myelodysplasia related dysplasia and 20-29% marrow blasts All female subjects of childbearing potential have to have negative pregnancy test within 2 weeks prior to inclusion to the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: No genetic aberration identified either in screening next generation sequencing panel or next generation sequencing panel performed at diagnosis Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders Mental inability, reluctance or language difficulties that results in difficulty understanding the meaning of study participation

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): MRD positive cohort: Relapse-free survival Proportion of MRD positive subjects achieving MRD-negativity Incidence and severity of GVHD Safety in MRD positive subjects subjected to MRD-guided clinical intervention Whole study cohort: Relapse-free survival Incidence and severity of GVHD Overall survival ;Timepoint(s) of evaluation of this end point: Weeks: 6, 12, 18, 24; months: 9, 12, 15, 18, 21 and 2 years after SCT	—

Measure

Time frame

Secondary end point(s): MRD positive cohort: Relapse-free survival Proportion of MRD positive subjects achieving MRD-negativity Incidence and severity of GVHD Safety in MRD positive subjects subjected to MRD-guided clinical intervention Whole study cohort: Relapse-free survival Incidence and severity of GVHD Overall survival ;Timepoint(s) of evaluation of this end point: Weeks: 6, 12, 18, 24; months: 9, 12, 15, 18, 21 and 2 years after SCT

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Primary

Measure	Time frame
Main Objective: The primary study objective is to prevent clinical events (relapse or non-relapse death) in minimal residual disease (MRD) positive subjects ;Secondary Objective: MRD positive cohort: To induce molecular remission To evaluate the incidence and severity of graft-versus-host disease (GVHD) To evaluate safety during pre-emptive treatment Whole study cohort: To prevent relapse or non-relapse death To evaluate the incidence and severity of GVHD To prolong overall survival ;Primary end point(s): 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);Timepoint(s) of evaluation of this end point: 12 months from MRD positivity	—

Measure

Time frame

Main Objective: The primary study objective is to prevent clinical events (relapse or non-relapse death) in minimal residual disease (MRD) positive subjects ;Secondary Objective: MRD positive cohort: To induce molecular remission To evaluate the incidence and severity of graft-versus-host disease (GVHD) To evaluate safety during pre-emptive treatment Whole study cohort: To prevent relapse or non-relapse death To evaluate the incidence and severity of GVHD To prolong overall survival ;Primary end point(s): 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);Timepoint(s) of evaluation of this end point: 12 months from MRD positivity

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Countries

Finland, Norway

Contacts

Public ContactCoordinating Investigator

Karolinska University Hospital

magnus.tobiasson@ki.se468585 800 00

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026