## Protocol Section
### Identification Module
**NCT ID:** NCT05788679

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

**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

#### Organization Study ID Info
**ID:** NMDSG14B, part 2
#### Organization
**Class:** OTHER
**Full Name:** Karolinska University Hospital
### Status Module
#### Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-05

**Type:** ACTUAL

**Last Update Submit Date:** 2023-12-04

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-11-22

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2023-03-29
**Type:** ACTUAL
**Study First Submit Date:** 2023-01-27
**Study First Submit QC Date:** 2023-03-27
### Sponsor Collaborators Module

#### Collaborators

**Class:** NETWORK

**Name:** Nordic MDS Group

#### Lead Sponsor

**Class:** OTHER

**Name:** Karolinska University Hospital

#### Responsible Party

**Investigator Affiliation:** Karolinska University Hospital

**Investigator Full Name:** Magnus Tobiasson

**Investigator Title:** Coordinating investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Myelodysplastic Syndromes

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

- Mixed Myelodysplastic/Myeloproliferative Disease

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Azacitidine and / or Donor lymphocytes or tapering of immune suppression

**Intervention Names:**

- Drug: Azacitidine

- Other: Donor lymphocytes

- Other: Tapering of immune suppression

**Label:** Intervention in MRD positive patients

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention in MRD positive patients

**Description:** Azacitidine

**Name:** Azacitidine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Intervention in MRD positive patients

**Description:** Donor lymphocytes in patients without immune suppression

**Name:** Donor lymphocytes

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Intervention in MRD positive patients

**Description:** Tapering of immune suppression in patients who are on immune suppressive drugs

**Name:** Tapering of immune suppression

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** 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

**Measure:** Number of MRD+ patients achieving MRD negativity

**Time Frame:** From MRD positivity until 2y after transplantation

**Measure:** Incidence and severity of graft-versus host disease

**Time Frame:** From transplantation until 2y after transplantation

**Measure:** Safety, adverse events reporting

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

**Measure:** Relapse-free survival

**Time Frame:** From transplantation until 2y after transplantation

**Measure:** Overall survival

**Time Frame:** From transplantation until 2y after transplantation

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** magnus.tobiasson@ki.se

**Name:** Magnus Tobiasson, PhD

**Phone:** 0046858580000

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Stockholm

**Contacts:**

***Contact 1:***

- **Name:** Magnus Tobiasson, PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Andreas Björklund

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Sweden

**Facility:** Department of Hematology, Karolinska University Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Karolinska University Hospital

**Name:** Magnus Tobiasson, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000001855

- Term: Bone Marrow Diseases

- ID: D000011230

- Term: Precancerous Conditions

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10945

- Name: Leukemia

- Relevance: LOW

- As Found: Unknown

- ID: M10955

- Name: Leukemia, Myeloid

- Relevance: LOW

- As Found: Unknown

- ID: M18127

- Name: Leukemia, Myeloid, Acute

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M12149

- Name: Myeloproliferative Disorders

- Relevance: HIGH

- As Found: Myeloproliferative Diseases

- ID: M14164

- Name: Preleukemia

- Relevance: HIGH

- As Found: Myelodysplastic Syndrome

- ID: M12145

- Name: Myelodysplastic Syndromes

- Relevance: HIGH

- As Found: Myelodysplastic Syndrome

- ID: M20497

- Name: Neoplasm, Residual

- Relevance: LOW

- As Found: Unknown

- ID: M27707

- Name: Myelodysplastic-Myeloproliferative Diseases

- Relevance: HIGH

- As Found: Myelodysplastic/myeloproliferative disease

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5134

- Name: Bone Marrow Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14111

- Name: Precancerous Conditions

- Relevance: LOW

- As Found: Unknown

- ID: T3995

- Name: Myeloid Leukemia

- Relevance: LOW

- As Found: Unknown

- ID: T182

- Name: Acute Myeloid Leukemia

- Relevance: HIGH

- As Found: Acute Myeloid Leukemia

- ID: T188

- Name: Acute Non Lymphoblastic Leukemia

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T1311

- Name: Chronic Myeloproliferative Disorders

- Relevance: HIGH

- As Found: Myeloproliferative Diseases

- ID: T3993

- Name: Myelodysplastic Syndromes

- Relevance: HIGH

- As Found: Myelodysplastic Syndrome

- ID: T3994

- Name: Myelodysplastic/myeloproliferative Disease

- Relevance: HIGH

- As Found: Myelodysplastic/myeloproliferative disease

### Condition Browse Module - Meshes

- ID: D000011289

- Term: Preleukemia

- ID: D000009190

- Term: Myelodysplastic Syndromes

- ID: D000009196

- Term: Myeloproliferative Disorders

- ID: D000054437

- Term: Myelodysplastic-Myeloproliferative Diseases

### Intervention Browse Module - Ancestors

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000004791

- Term: Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4673

- Name: Azacitidine

- Relevance: HIGH

- As Found: Side

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000001374

- Term: Azacitidine

### Misc Info Module

- Version Holder: 2024-05-24
