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
Condition: Precursor Cell Lymphoblastic Leukemia-Lymphoma
MeSH terms: Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Intervention: Daratumumab; Vincristine; Prednisone; Doxorubicin; Peg-asparaginase; Cyclophosphamide; Cytarabine; 6-mercaptopurine; Methotrexate
Intervention description: Participant will receive daratumumab 16 milligram per kilogram (mg/kg) in cohort 1 and cohort 2.; Participant will receive vincristine 1.5 milligram per meter square (mg/m^2) in cohort 1 and cohort 2.; Participant will receive prednisone 40 mg/m^2 in cohort 1 and cohort 2.; Participant will receive doxorubicin 60 mg/m^2 in cohort 2.; Participant will receive peg-asparaginase 2500 units per meter square (U/m^2) in cohort 2.; Participant will receive cyclophosphamide 1 gram per meter square (g/m^2) once in cohort 2.; Participant will receive cytarabine 75 mg/m^2 in cohort 2.; Participant will receive 6-mercaptopurine 60 mg/m^2 orally daily in cohort 2.; Participant will receive methotrexate 5 g/m^2 intravenously (IV) in cohort 2.
Intervention MeSH terms: Cytarabine; Prednisone; Cyclophosphamide; Doxorubicin; Methotrexate; Vincristine; Asparaginase; Daratumumab; Mercaptopurine; Pegaspargase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 1 Year
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL) as
             defined by the criteria below:

               1. B-cell cohort: Stage 1; ALL in second or greater relapse or refractory to 2 prior
                  induction regimens with greater than or equal to (>=) 5 percent (%) blasts in the
                  bone marrow and aged 1 to less than (<) 18 years. Stage 2; ALL in second or
                  greater relapse or refractory to 2 prior induction regimens with (>=) 5% blasts
                  in the bone marrow and aged 1 to 30 years. LL in second or greater relapse or
                  refractory to 2 prior induction regimens and biopsy proven and with evidence of
                  measurable disease by radiologic criteria and aged 1 to 30 years.

               2. T-cell cohort: Stage 1; ALL in first relapse or refractory to 1 prior
                  induction/consolidation regimen with (>=) 5% blasts in the bone marrow and aged 1
                  to <18 years. Stage 2; ALL in first relapse or refractory to 1 prior
                  induction/consolidation regimen with (>=) 5% blasts in the bone marrow and aged 1
                  to 30 years. LL in first relapse or refractory to 1 prior induction/consolidation
                  regimen biopsy proven and with evidence of measurable disease by radiologic
                  criteria and aged 1 to 30 years

          -  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 defined as follows:

               1. Hemoglobin (>=) 7.5 gram per deciliter (g/dL) ([>=] 5 millimole per liter
                  [mmol/L]; prior red blood cell [RBC] transfusion is permitted)

               2. Platelet count (>=) 10*10^9 per liter (L) (prior platelet transfusion is
                  permitted)

          -  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 defined as:

               1. Alanine aminotransferase level less than or equal to (<=) 2.5* the upper limit of
                  normal (ULN),

               2. Aspartate aminotransferase level (<=) 2.5* ULN, and

               3. Total bilirubin (<=) 2* ULN or direct bilirubin level (<=) 2.0* ULN

        Exclusion Criteria:

          -  Received an allogeneic hematopoietic transplant within 3 months of screening

          -  Active acute graft-versus-host disease of any grade or chronic graft-versus-host
             disease of Grade 2 or higher

          -  Received immunosuppression post hematopoietic transplant within 1 month of study entry

          -  Philadelphia chromosome positive (Ph+) B-cell ALL eligible for tyrosine kinase
             inhibitor therapy

          -  Has either of the following:

               1. Evidence of dyspnea at rest or oxygen saturation (<=) 94 percent (%).

               2. Known moderate or severe persistent asthma within the past 2 years, or
                  uncontrolled asthma of any classification

          -  Received an investigational drug, was vaccinated with live attenuated vaccines, or
             used an invasive investigational medical device within 4 weeks before the planned
             first dose of study drug, or is currently being treated in an investigational study

          -  Known to be seropositive for human immunodeficiency virus (HIV)

          -  Any one of the following:

               1. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface
                  antigen [HBsAg]). Participants with resolved infection (ie, participants who are
                  HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc]
                  and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened
                  using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus
                  (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be
                  excluded

               2. Known to be seropositive for hepatitis C (except in the setting of a sustained
                  virologic response [SVR], defined as aviremia at least 12 weeks after completion
                  of antiviral therapy)