Individual Molecular MRD Monitoring for MDS Patients After Allo-SCT

NCT02872662 | Completed

• 1 other identifier: NMDSG14B
• Study Type: observational
• Target: 308
• Locations: 3 countries
• Sites: 8

Brief Summary

This study aims to develop highly sensitive methods for early detection of relapse based on the patients unique mutations. Initially, a mutational screen is being performed. Primers directed against these mutations will be constructed and presence of mutations will be followed in bone marrow and blood frequently after transplantation.

Conditions

MDS; SCT; MRD

Outcome Measures

Primary Outcomes (1)

• Level of variant allele frequency (MRD) associated with full hematological relapse

  MRD is a quantative variable defined as variant allele frequency of patient-specific mutations. The association between MRD and relapse and survival will be studied.

  From inclusion up to end of study (August 2019)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 consecutive MDS patients undergoing allogeneic SCT

You may qualify if:

• MDS with allo SCT to be performed
• One or more mutations identified
• Written informed consent

Sponsors & Collaborators

• Nordic MDS Group: lead
• Helsinki University Central Hospital: collaborator

Study Sites (8)

Department of Hematology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Department of Hematology, Rigshospitalet Univsersity Hospital

Copenhagen, Denmark

Location

Department of Medcine, Haukeland University Hospital

Bergen, Norway

Location

Department of Hematology, Rikshospitalet University Hospital

Oslo, 0027, Norway

Location

Department of Hematology and Coagulation, Sahlgrenska University hospital

Gothenburg, 413 45, Sweden

Location

Department of Hematology, Lund University Hospital

Lund, 221 85, Sweden

Location

Department of Hematology, Karolinska University Hospital

Stockholm, Sweden

Location

Department of Hematology, Akademiska University Hospital

Uppsala, 751 85, Sweden

Location

Related Publications (1)

• Tobiasson M, Pandzic T, Illman J, Nilsson L, Westrom S, Ejerblad E, Olesen G, Bjorklund A, Olsnes Kittang A, Werlenius O, Lorentz F, Rasmussen B, Cammenga J, Weber D, Lindholm C, Wiggh J, Dimitriou M, Moen AE, Yip Lundstrom L, von Bahr L, Baltzer-Sollander K, Jadersten M, Kytola S, Walldin G, Ljungman P, Groenbaek K, Mielke S, Jacobsen SEW, Ebeling F, Cavelier L, Smidstrup Friis L, Dybedal I, Hellstrom-Lindberg E. Patient-Specific Measurable Residual Disease Markers Predict Outcome in Patients With Myelodysplastic Syndrome and Related Diseases After Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2024 Apr 20;42(12):1378-1390. doi: 10.1200/JCO.23.01159. Epub 2024 Jan 17.

  PMID: 38232336 DERIVED

Study Officials

• Eva Hellström-Lindberg, Prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: August 19, 2016
• Study Start: August 1, 2016
• Primary Completion: November 22, 2021
• Study Completion: November 22, 2021
• Last Updated: April 24, 2026

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

NO (2); DK (2); SE (4)