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

Karolinska University Hospital

Status and phase

Enrolling

Phase 2

Conditions

Myelodysplastic Syndromes

Mixed Myelodysplastic/Myeloproliferative Disease

Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts

Treatments

Other: Tapering of immune suppression

Other: Donor lymphocytes

Drug: Azacitidine

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT05788679

NMDSG14B, part 2

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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