A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS

Phase 2RecruitingNCT05788679

Karolinska University Hospital200 enrolled

Overview

The goal of this interventional study is to evaluate if pre-emptive intervention using Azacitidine and / or donor lymphocytes or tapering of immune suppression in measurable residual disease (MRD) positive subjects can prevent clinical relapse. Participants will undergo MRD surveillance and be subjected to intervention in case of MRD positivity. Results will be compared with NMDSG14B, part one, in which MRD was analyzed in included patients without recieving intervention.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Myelodysplastic Syndromes Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts Mixed Myelodysplastic/Myeloproliferative Disease

Interventions

AzacitidineDRUG

Azacitidine

Donor lymphocytesOTHER

Donor lymphocytes in patients without immune suppression

Tapering of immune suppressionOTHER

Tapering of immune suppression in patients who are on immune suppressive drugs

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Signed informed consent * Age ≥ 18 years * Subjects eligible for 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 Exclusion Criteria: * No traceable 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

Outcomes

Primary Outcomes

Clinical event defined as relapse or death within 1 year from first MRD+ sample

Time frame: Within 1 year from first MRD+ sample

Secondary Outcomes

Number of MRD+ patients achieving MRD negativity

Time frame: From MRD positivity until 2y after transplantation

Incidence and severity of graft-versus host disease

Time frame: From transplantation until 2y after transplantation

Safety, adverse events reporting

Time frame: After start of Azacitidine until 30 days after last azacitidine injection

Relapse-free survival

Time frame: From transplantation until 2y after transplantation

Overall survival

Time frame: From transplantation until 2y after transplantation

A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts