Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA with High Risk T-Cell ALL & Lymphoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 22, 2023

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2028

Conditions
T-cell Acute Lymphoblastic LeukemiaT-Cell Acute Lymphoblastic Lymphoma
Interventions
DRUG

Daratumumab

"Total body irradiation (TBI)-based myeloablative allogeneic hematopoietic stem cell transplantation (HCT) using best available donor.~Daratumumab (DARA) treatment post-HCT Phase 1: 3 dose levels to determine safety (15 patients)~Dose expansion:~1. Induction: DARA IV weekly x 8 doses (Weeks 1-8)~2. Consolidation: DARA every 2 weeks x 8 doses (Weeks 9-24)~3. Maintenance: DARA every 4 weeks (Stop at Day +270)"

Trial Locations (16)

10595

RECRUITING

New York Medical College, Vallhala

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

20010

NOT_YET_RECRUITING

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

32608

RECRUITING

University of Florida, Gainsville

33701

NOT_YET_RECRUITING

John Hopkins All Children's Hospital, St. Petersburg

43205

NOT_YET_RECRUITING

Nationwide Children's Hosptial, Columbus

46202

RECRUITING

Riley Children's Hospital, Indianapolis

49503

RECRUITING

Helen DeVos Children's Hospital, Grand Rapids

53226

NOT_YET_RECRUITING

Medical College of Wisconsin, Milwaukee

77030

NOT_YET_RECRUITING

MD Anderson Cancer Center, Houston

80045

NOT_YET_RECRUITING

Children's Hospital Colordao, Aurora

85016

NOT_YET_RECRUITING

Phoenix Children's Hospital, Phoeniz

90095

NOT_YET_RECRUITING

University of California, Los Angeles

92354

RECRUITING

Loma Linda University Children's Hospital, Loma Linda

94143

NOT_YET_RECRUITING

University of California, San Francisco

02115

NOT_YET_RECRUITING

Boston Children's Hospital, Boston

Sponsors
All Listed Sponsors
lead

New York Medical College

OTHER

NCT04972942 - Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA with High Risk T-Cell ALL & Lymphoma | Biotech Hunter | Biotech Hunter