Efficacy and Safety of Daratumumab in Pediatric and Young Adults With Relapsed or Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Patients must have Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma.
The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete response (CR) rate. Screening for eligible participants will be performed within 21 days before administration of the study drug. Participants with B-cell ALL/LL will receive treatment until disease progression, unacceptable toxicity or achievement of CR followed by hematopoietic stem cell transplant (HSCT). Participants with T cell ALL/LL will receive treatment for up to 2 cycles. If disease progression is confirmed, then the participant will discontinue study treatment, complete the End of Treatment Visit, and enter the Posttreatment Period. For those participants who discontinue study drug prior to disease progression, disease evaluations will continue to be performed every 4 weeks until subsequent anticancer therapy is initiated.
- Ages eligible for study: 1 year to 30 years (Child, Adult)
- Documented acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL)
- Performance status greater than or equal to (>=) 70 by Lansky scale (for participants less than [<] 16 years of age) or Karnofsky scale (for participants [>=] 16 years of age)
- Adequate hematology laboratory values at Cycle 1 Day 1 pre-dosing
- Adequate renal function defined as normal serum creatinine for the participant's age or creatinine clearance or radioisotope glomerular filtration rate (GFR) 70 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) prior to enrollment
- Adequate liver function prior to enrollment
Detailed inclusion and exclusion criteria as listed on clinicaltrials.gov.
Eric S. Schafer, MD
Local Principal Investigator
Texas Children’s Cancer and Hematology Centers