Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies

PHASE1RecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

November 11, 2022

Primary Completion Date

November 11, 2025

Study Completion Date

November 11, 2027

Conditions
Hematologic MalignancyAMLALLBPDCNMDSLymphoblastic LymphomaLymphoma, B-CellLymphoma, T-CellHodgkin LymphomaMixed Phenotype Acute LeukemiaAcute Undifferentiated Leukemia
Interventions
DRUG

Tagraxofusp

Dose will be assigned at study entry. Give IV over 15 minutes.

DRUG

Fludarabine

"30 mg/m\^2 will be given IV over 30 minutes on days 1-5.~Infusion will start 30 minutes after start of tagraxofusp on days 4 and 5."

DRUG

Cytarabine

2000 mg/m2 intravenously will be given daily over 1-3 hours for 5 days on days 1 through 5. Infusion will begin 4 hours after start of fludarabine. Because of an increased risk of neurotoxicity, it is recommended that IT cytarabine be separated from high dose IV cytarabine administration by at least 24 hours on C1D1.

DRUG

Dexamethasone

"* 20 mg/m2/day divided BID (max 40 mg/day) given orally on days 1 through 5 and 15 through 19. The two doses should be separated by at least 8 hours.~* Any oral formulation of dexamethasone is acceptable.~* IV may be given if oral formulation is not tolerated"

DRUG

Vincristine

"* 1.5 mg/m2 (maximum dose 2 mg) given intravenously as an IV push over 1-5 minutes or infusion via minibag as per institutional policy on days 1, 8, 15, and 22.~* Infusion will start 30 minutes after start of tagraxofusp on day 8."

DRUG

Azacitidine

"* 75 mg/m2 subcutaneously or intravenously will be given daily over 15 minutes for 5 days on days 1 through 5.~* Azacitidine will be given 30-60 minutes before beginning the tagraxofusp infusion."

DRUG

Methotrexate

"Give intrathecally:~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients ≥9 years of age"

DRUG

Cytarabine IT

"Give intrathecally:~* 30 mg for patients age 1-1.99~* 50 mg for patients age 2-2.99~* 70 mg for patients ≥3 years of age~If given as part of Triple IT Therapy:~AML Patients:~Age 1-1.99 - 24 mg Age 2-2.99 - 30 mg Age ≥3 years of age - 36 mg~AML Patients:~Age 1-1.99 - 16 mg Age 2-2.99 - 20 mg Age 3-8.99 - 24 mg Age ≥9 years of age - 30 mg"

DRUG

Hydrocortisone

"Given intrathecally.~AML Patients:~Age 1-1.99 - 16 mg Age 2-2.99 - 20 mg Age ≥3 years of age - 24 mg~AML Patients:~Age 1-1.99 - 8 mg Age 2-2.99 - 10 mg Age 3-8.99 - 12 mg Age ≥9 years of age - 15 mg"

Trial Locations (31)

10032

NOT_YET_RECRUITING

Children's Hospital New York-Presbyterian, New York

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

19104

NOT_YET_RECRUITING

Children's Hospital of Philadelphia, Philadelphia

20010

RECRUITING

Children's National Medical Center, Washington D.C.

20892

NOT_YET_RECRUITING

National Cancer Institute, Pediatric Oncology Branch, Bethesda

21231

NOT_YET_RECRUITING

Johns Hopkins University, Baltimore

28204

NOT_YET_RECRUITING

Carolina-Levine Children's Hospital, Charlotte

30322

NOT_YET_RECRUITING

Children's Healthcare of Atlanta, Emory University, Atlanta

33136

NOT_YET_RECRUITING

University of Miami, Miami

38105

NOT_YET_RECRUITING

St. Jude Children's Research Hospital, Memphis

43205

NOT_YET_RECRUITING

Nationwide Children's Hospital, Columbus

44106

NOT_YET_RECRUITING

Rainbow Babies, Cleveland

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

RECRUITING

Riley Hospital for Children, Indianapolis

53226

RECRUITING

Children's Hospital of Wisconsin, Milwaukee

55404

NOT_YET_RECRUITING

Children's Hospital and Clinics of Minnesota, Minneapolis

60611

RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

75235

RECRUITING

University of Texas, Southwestern, Dallas

76104

RECRUITING

Cook Children's Hospital, Fort Worth

77030

RECRUITING

Texas Children's Hospital/Baylor College of Medicine, Houston

80045

RECRUITING

Children's Hospital Colorado, Denver

84113

RECRUITING

Primary Children's Hospital, Salt Lake City

90027

RECRUITING

Children's Hospital Los Angeles, Los Angeles

92868

NOT_YET_RECRUITING

Children's Hospital Orange County, Orange

97239

NOT_YET_RECRUITING

Oregon Health & Science University, Portland

98105

NOT_YET_RECRUITING

Seattle Children's Hospital, Seattle

94143-0106

RECRUITING

UCSF School of Medicine, San Francisco

02215

NOT_YET_RECRUITING

Dana-Farber Cancer Institute, Boston

48109-0914

RECRUITING

C.S. Mott Children's Hospital, Ann Arbor

Unknown

RECRUITING

Children's Hospital at Westmead, Westmead

NOT_YET_RECRUITING

Sydney Children's Hospital, Sydney

All Listed Sponsors
lead

Therapeutic Advances in Childhood Leukemia Consortium

OTHER