A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Conditions

• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Eligibility Criteria

Sex

ALL

Age

1 Year - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Daratumumab — DRUG
  Participant will receive daratumumab 16 milligram per kilogram (mg/kg) in cohort 1 and cohort 2.
• Vincristine — DRUG
  Participant will receive vincristine 1.5 milligram per meter square (mg/m\^2) in cohort 1 and cohort 2.
• Prednisone — DRUG
  Participant will receive prednisone 40 mg/m\^2 in cohort 1 and cohort 2.
• Doxorubicin — DRUG
  Participant will receive doxorubicin 60 mg/m\^2 in cohort 2.
• Peg-asparaginase — BIOLOGICAL
  Participant will receive peg-asparaginase 2500 units per meter square (U/m\^2) in cohort 2.
• Cyclophosphamide — DRUG
  Participant will receive cyclophosphamide 1 gram per meter square (g/m\^2) once in cohort 2.
• Cytarabine — DRUG
  Participant will receive cytarabine 75 mg/m\^2 in cohort 2.
• 6-mercaptopurine — DRUG
  Participant will receive 6-mercaptopurine 60 mg/m\^2 orally daily in cohort 2.
• Methotrexate — DRUG
  Participant will receive methotrexate 5 g/m\^2 intravenously (IV) in cohort 2.

Study Details

The purpose of this study is to evaluate the efficacy of daratumumab in addition to standard chemotherapy in pediatric participants with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LL) and T-cell ALL/LL as measured by the complete response (CR) rate.

Key Dates

Start date

May 14, 2018

Status verified

May 2025

Primary completion

Sep 22, 2022

Completion

Sep 27, 2022

Study Design

Enrollment

47 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: B-Cell Acute Lymphoblastic Leukemia (ALL)/LL
  Cohort 1 will include participants with B cell ALL/LL in second or greater relapse or refractory to at least 2 prior induction regimens. Participant will receive daratumumab in combination with vincristine and prednisone.
• Experimental: Cohort 2: T-Cell ALL/LL
  Cohort 2 will include participants with T-cell ALL/LL in first relapse or refractory to at least 1 prior induction/consolidation regimen. Participant will receive daratumumab in combination with vincristine, prednisone, doxorubicin and peg-asparaginase in Cycle 1 and daratumumab in combination with cyclophosphamide, cytarabine, 6- mercaptopurine and methotrexate in Cycle 2.

Primary Outcome Measure

Cohort 1: Percentage of Participants With Complete Response (CR) for B-cell Acute Lymphoblastic Leukemia (ALL) [ Time Frame: Up to 2 cycles, that is, up to 56 days (each cycle of 28-days) ]

Locations (26)

Find similar trials in Birmingham, AL

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