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Table 2 Select ongoing trials for which patients with MRD are eligible

From: Prognostic and therapeutic implications of measurable residual disease in acute myeloid leukemia

Trial number

Phase

Patient population

Timing of MRD positivity

Intervention

Primary Outcome

MRD platform

NCT04809181

2

AML/MDS; < 65 years

After allo-HSCT

Azacitidine + venetoclax

RFS

MFC or RT-qPCR

NCT04689815

2

NPM1-mutant AML

After consolidation or post-HSCT

Azacitidine + arsenic trioxide

Rate of NPM1 MRD negativity

RT-qPCR

NCT04712942

2

AML/MDS

After consolidation or post-HSCT

Azacitidine +/− pevonedistat

MRD status

MFC or RT-qPCR

NCT04086264

1/2

CD123+ AML

After frontline treatment

IMGN632

Antileukemia activity, MRD levels

MFC

NCT03769532

2

NPM1-mutant AML; post-HSCT excluded

After chemotherapy

Azacitidine + Pembrolizumab

EFS

RT-qPCR

NCT04541277

2

AML with PDL1 expression; > 60 years or unfit for intensive chemotherapy; post-HSCT excluded

Not specified

Tislelizumab + HMA +/− CAG

ORR

Not specified

NCT02684162

2

AML/MDS

After allo-HSCT

Guadecitabine + DLI

CRR, RFS

MFC, RT-qPCR, NGS

NCT02789254

1/2

AML with FLT3 expression; post-HSCT excluded

After any therapy

FLYSYN

Safety/tolerability

NGS or RT-qPCR

NCT02520427

1

AML/MDS

Not specified

AMG330

Safety/tolerability

Not specified

NCT02275533

2

AML in first remission

After induction or consolidation

Nivolumab

PFS

Not specified

NCT04623216

1/2

AML in remission after HSCT

After allo-HSCT

Sabatolimab +/− Azacitidine

Safety/tolerability, CRR

Not specified

NCT02126553

2

AML ≤ 55 years

After induction

Lenalidomide

RFS

MFC, RT-qPCR

NCT02770820

1/2

Elevated WT1 expression, HLA-A*02.01 genotype

After induction or consolidation

WT1 directed allo-CD8 T cells

Safety/tolerability

MFC, RT-qPCR

NCT04209712

1

AML (includes children)

After 2 courses of chemotherapy

allo-NK cells

MRD response

MFC

NCT04632316

1/2

AML/MDS

After consolidation

oNKord

Safety/tolerability, MRD response

MFC

NCT04284228

1/2

AML/MDS; HLA-A2.01 expression

After allo-HSCT

NEXI-001

Safety/tolerability, PFS, ORR, OS

MFC or NGS

NCT03697707

2

AML in first remission

After induction or consolidation

DCP-001

MRD response

MFC

NCT04580121

1

HLA-A*02 genotype

Any time

RO7283420

Safety/tolerability

MFC

NCT03737955

2

CD33+ AML/MDS/MPN; (includes children)

Any time

Gemtuzumab ozogamicin

MRD response

MFC or RT-qPCR

NCT04526288

2

AML/MDS

After chemotherapy

allo-HSCT +/− preceding CPX351

OS

MFC, RT-qPCR, NGS, FISH, or cytogenetics

NCT03537599

1/2

AML

After allo-HSCT

Daratumumab + DLI

Safety/tolerability, ORR

MFC, NGS, or cytogenetics

NCT03793517

2/3

Acute leukemias with MLL-r, TLS-ERG, or SIL-TAL1; < 55 years

pre-HSCT

Decitabine + mBu/Cy + allo-HSCT

CIR

Not specified

NCT03728335

1

IDH2-mutated AML

After allo-HSCT

Enasidenib

Safety/tolerability

MFC, NGS

NCT04326764

3

AML/MDS

pre-HSCT

Panabinostat

OS

MFC or RT-qPCR

  1. MRD measurable residual disease, AML acute myeloid leukemia, MDS myelodysplastic syndrome, allo-HSCT allogeneic hematopoietic stem cell transplant, RFS remission-free survival, MFC multiparameter flow cytometry, RT-qPCR reverse transcription-quantitative polymerase chain reaction, EFS event-free survival, HMA hypomethylating agent, CAG cytarabine, idarubicin, granulocyte colony-stimulating factor, ORR overall response rate, DLI donor lymphocyte infusion, CRR complete response rate, NGS next-generation sequencing, PFS progression-free survival, allo-NK cells allogeneic natural killer cells, OS overall survival, mBu/Cy modified busulfan and cyclophosphamide