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 Leuk

Status: Recruiting
Phase:
DFCI Protocol ID: 18-491

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.

Conducting Institutions:

Children's Hospital Boston, Dana-Farber Cancer Institute

Overall PI:

Site-responsible Investigators:

Contacts:

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)

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