Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 25, 2023

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
T-cell Acute Lymphoblastic Leukemia
Interventions
DRUG

Daratumumab / Hyaluronidase Injection

Daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 1, 8, 15, and 22

DRUG

Daratumumab / Hyaluronidase Injection

Patients that are MRD Negative on Day 29 will receive daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 36, 43, 50, and 57.

DRUG

Daratumumab / Hyaluronidase Injection

"Patients that remain MRD positive on Day 29 will receive a combination of daratumumab-hyaluronidase 1800mg/ 30,000 units once weekly for 4 doses on Days 36, 43, 50, and 57 and chemotherapy selected from the combinations listed below:~* Cytarabine 3000 mg/m2, IV, Every 12 hours for 4 doses on Days 37 and 38~* Methotrexate 1000 mg/m2, IV, Over 24 hours on Day 36~OR~* Methotrexate, Starting dose 100 mg/m2, IV, Days 36, 46, 56~* Vincristine, 1.5 mg/m2 (2 mg cap), IV, Days 36, 46, 56~* Pegaspargase, 2000 IU/m2 (Capped at 3750 IU), IV Days 37, 57~* Methotrexate 15 mg, IT, Days 36, 56"

DRUG

Daratumumab / Hyaluronidase Injection

All patients with MRD negative response after completion of previous course are eligible for daratumumab-hyaluronidase 1800mg/ 30,000 units every 2 weeks on Days 1,15, 29, 43, 57, 71, 85, and 99 for 8 doses.

Trial Locations (1)

60611

RECRUITING

Northwestern, Chicago

All Listed Sponsors
collaborator

Janssen, LP

INDUSTRY

lead

Eastern Cooperative Oncology Group

NETWORK