"Use of a New Medicine Daratumumab to Treat Left-over Cancer in a Blood Cancer Called T Acute Lymphoblastic Leukemia"

PHASE2RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

August 28, 2023

Primary Completion Date

August 28, 2026

Study Completion Date

August 28, 2026

Conditions
T Acute Lymphoblastic Leukemia
Interventions
DRUG

Daratumumab Injection

"Patients will receive intravenous daratumumab (16mg/kg per dose) once weekly for 2 doses. After 2 doses, they will undergo bone marrow examination for flow-cytometric MRD. Those who become MRD negative (less than 0.01% by flow-cytometry), will be off-study and continued on conventional treatment regimen as per institution policy. Hence, total duration in those who become MRD negative will be 3 weeks.~However, those who are still MRD positive (more than or equal to 0.01% by flowcytometry) after two doses, will be given two additional once weekly doses of intravenous daratumumab (16mg/kg per dose). In patients who receive two additional doses, bone marrow aspirate for MRD analysis will be done 7 days after fourth dose of daratumumab. Irrespective of MRD result after fourth dose, patients will be continued on conventional treatment regimen"

Trial Locations (1)

410210

RECRUITING

Dr.Sumeet Mirgh, Navi Mumbai

All Listed Sponsors
lead

Tata Memorial Centre

OTHER