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

• Sponsor: Karolinska University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05788679
• Collaborator: Nordic MDS Group (Other)
• Enrollment: 200
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 48.3
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes; Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts; Mixed Myelodysplastic/Myeloproliferative Disease	Drug: Azacitidine; Other: Donor lymphocytes; Other: Tapering of immune suppression	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Nov 22, 2022
• Anticipated Primary Completion Date: Dec 1, 2026
• Anticipated Study Completion Date: Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention in MRD positive patients Azacitidine and / or Donor lymphocytes or tapering of immune suppression	Drug: Azacitidine; Azacitidine; Other: Donor lymphocytes; Donor lymphocytes in patients without immune suppression; Other: Tapering of immune suppression; Tapering of immune suppression in patients who are on immune suppressive drugs

Outcome Measures

Primary Outcome Measures

1. Clinical event defined as relapse or death within 1 year from first MRD+ sample [Within 1 year from first MRD+ sample]

Secondary Outcome Measures

1. Number of MRD+ patients achieving MRD negativity [From MRD positivity until 2y after transplantation]

2. Incidence and severity of graft-versus host disease [From transplantation until 2y after transplantation]

3. Safety, adverse events reporting [After start of Azacitidine until 30 days after last azacitidine injection]

4. Relapse-free survival [From transplantation until 2y after transplantation]

5. Overall survival [From transplantation until 2y after transplantation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Hematology, Karolinska University Hospital	Stockholm		Sweden

Sponsors and Collaborators

• Karolinska University Hospital
• Nordic MDS Group

Investigators

• Principal Investigator: Magnus Tobiasson, PhD, Karolinska University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Magnus Tobiasson, Coordinating investigator, Karolinska University Hospital
• ClinicalTrials.gov Identifier: NCT05788679
• Other Study ID Numbers: NMDSG14B, part 2
• First Posted: Mar 29, 2023
• Last Update Posted: Mar 29, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Preleukemia; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Azacitidine

Study Results

No Results Posted as of Mar 29, 2023