TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

November 3, 2023

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2033

Conditions
Lymphoblastic Leukemia
Interventions
DRUG

Dexamethasone

Given orally (PO) or naso-gastrically (NG) or intravenously (IV).

DRUG

Mitoxantrone

Given IV

DRUG

PEG asparaginase

Given IV

DRUG

Bortezomib

Given IV

DRUG

Vorinostat

Taken PO or NG

DRUG

Mercaptopurine

Given PO or NG.

DRUG

Methotrexate

Given IV, IM or PO

DRUG

Blinatumomab

Will be administered at 15 mcg/m2/day for 28 days following induction and reinduction

DRUG

Ziftomenib

3+3 dose escalation will be done. Dose level 1 will start at 75% of the adult recommended phase two dosing which has been established in phase I studies. Based on tolerability, we will either de-escalate to 50% RP2D (dose level -1) or escalate to 100% RP2D

Trial Locations (25)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

23507

RECRUITING

Children's Hospital of The King's Daughters, Norfolk

28204

NOT_YET_RECRUITING

Novant Health - Hemby Children's Hospital, Charlotte

32806

NOT_YET_RECRUITING

Arnold Palmer Hospital for Children, Orlando

53705

NOT_YET_RECRUITING

University of Wisconsin Carbone Cancer Center, Madison

55404

RECRUITING

Children's Hospital of Minnesota, Minneapolis

72202

RECRUITING

Arkansas Children's Hospital, Little Rock

77030

RECRUITING

MD Anderson, Houston

78229

RECRUITING

University of Texas Health Science Center San Antonio, San Antonio

84108

NOT_YET_RECRUITING

University of Utah Huntsman Cancer Institute, Salt Lake City

85016

NOT_YET_RECRUITING

Phoenix Children's Hospital, Phoenix

90027

NOT_YET_RECRUITING

Children's Hospital Los Angeles, Los Angeles

92123

NOT_YET_RECRUITING

Rady Children's Hospital San Diego, San Diego

92868

NOT_YET_RECRUITING

Children's Hospital of Orange County, Orange

93636

NOT_YET_RECRUITING

Valley Children's Hospital, Madera

94304

RECRUITING

Stanford University, Palo Alto

97239

NOT_YET_RECRUITING

Doernbecher Children's Hospital, Portland

17033-0850

NOT_YET_RECRUITING

Penn State Milton S Hershey Medical Center, Hershey

T3B 6A8

NOT_YET_RECRUITING

Alberta Children's Hospital, Calgary

T6G 2B7

NOT_YET_RECRUITING

Stollery Children's Hospital, Edmonton

V6H 3V4

NOT_YET_RECRUITING

BC Children's Hospital, Vancouver

L8N 3Z5

NOT_YET_RECRUITING

McMaster Children's Hospital, Hamilton

H3T 1C5

NOT_YET_RECRUITING

CHU Sainte-Justine, Montreal

H4A 3J1

NOT_YET_RECRUITING

Montreal Children's Hospital, Montreal

G1V 4G2

NOT_YET_RECRUITING

Chu De Quebec, Québec

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Pediatric Oncology Experimental Therapeutics Investigators' Consortium

UNKNOWN

collaborator

Amgen

INDUSTRY

collaborator

Lucile Packard Foundation for Children's Health

UNKNOWN

collaborator

Kura Oncology, Inc.

INDUSTRY

lead

Tanja Andrea Gruber

OTHER

NCT05848687 - TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II | Biotech Hunter | Biotech Hunter