Table 1 Current and future trials of menin inhibitors in pediatric patients.

From: Menin inhibitors in pediatric acute leukemia: a comprehensive review and recommendations to accelerate progress in collaboration with adult leukemia and the international community

Current

Clinical trial/sponsor

Phase

Treatment

Biomarkers

Age eligibility

Location

AUGMENT-101 (NCT04065399)

1/2

Revumenib monotherapy

KMT2A-r, NPM1-m, NUP98-r

All ages; AML and ALL

Multisite- U.S. and Europe

AUGMENT-102 (NCT05326516)

1

Revumenib + FLA

KMT2A-r, NPM1-m, NUP98-r

All ages AML and ALL

Multisite- U.S. and Europe

SAVE (NCT05360160)

1/2

Revumenib + Venetoclax+ ASTX727

KMT2A-r, NPM1-m, NUP98-r (Frontline and Relapse)

≥12 years AML and MPAL

MD Anderson Cancer Center

TINI 2 (NCT05848687)

1

Ziftomenib + Multiagent

KMT2A-r

Infant ALL

Stanford University

AALL2121 / COG (NCT05761171)

2

Revumenib + Multiagent

KMT2A-r

30 days to 6 years ALL and MPAL

Multisite US

(NCT04811560)

1

JNJ-75276617 + Multiagent

KMT2A-r, NPM1-m, NUP98-r, NUP214-r

>12 years. AML and ALL

Multisite- US and Europe

(NCT06177067)

1

Revumenib + Venetoclax + Azacytidine.

KMT2A-r, NPM1-m, NUP98-r

1-30yo. AML and ALL

St Jude Children’s Hospital

FUTURE

 

1

Ziftomenib + Venetoclax + Azacytidine

KMT2A-r, NPM1-m, NUP98-r

<40 yo; AML and ALL

MD Anderson Cancer Center

APAL2020K ITCC-101/COG/PEDAL

1

Ziftomenib + FLA

KMT2A-r, NPM1-m, NUP98-r

<18 yo; AML and ALL

Multisite- U.S. and Europe

 

1

Ziftomenib + Venetoclax + Gemtuzumab

KMT2A-r, NPM1-m, NUP98-r, UBTF-ITD

<40 yo; AML and ALL

MD Anderson Cancer Center

 

1

Revumenib + AD + Gemtuzumab

KMT2A-r, NPM1-m, NUP98-r, UBTF-ITD

<40 yo; AML and ALL

MD Anderson Cancer Center

  1. *Early relapse is defined as relapse within one year of first complete remission.
  2. FLA fludarabine and cytarabine, IDA idarubicin, A cytarabine, D daunorubicin.