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
Precursor Cell Lymphoblastic Leukemia-Lymphoma
About this trial
This is an interventional treatment trial for Precursor Cell Lymphoblastic Leukemia-Lymphoma
Eligibility Criteria
Inclusion Criteria:
Documented acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL) as defined by the criteria below:
- 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.
- 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:
- Hemoglobin (>=) 7.5 gram per deciliter (g/dL) ([>=] 5 millimole per liter [mmol/L]; prior red blood cell [RBC] transfusion is permitted)
- 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:
- Alanine aminotransferase level less than or equal to (<=) 2.5* the upper limit of normal (ULN),
- Aspartate aminotransferase level (<=) 2.5* ULN, and
- 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:
- Evidence of dyspnea at rest or oxygen saturation (<=) 94 percent (%).
- 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:
- 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
- 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)
Sites / Locations
- University of Alabama at Birmingham
- Phoenix Children's Hospital
- UCSF Benioff Children's Hospital Oakland
- Children's Hospital Orange County
- Stanford University
- Children's Hospital Colorado
- Connecticut Children's Medical Center
- Children'S Healthcare Of Atlanta/Emory Univ. Dept. Of Pediatrics
- Ann & Robert H. Lurie Children's Hospital of Chicago
- Riley Hospital for Children
- Johns Hopkins University
- Dana-Farber Cancer Institute
- C.S. Mott Children's Hospital
- Washington Univeristy School of Medicine/ Pediatrics
- Newark Beth Israel Medical Center
- New York University Langone Medical Center
- Memorial Sloan Kettering Cancer Center
- Stony Brook University Medical Center
- Cincinnati Children's Hospital Medical Center
- Nationwide Children's Hospital
- Children's Hospital of Philadelphia
- Dell Children's Medical Center of Central Texas/Children's Blood and Cancer Center
- UT Southwestern Medical Center
- Baylor College of Medicine
- University of Utah Primary Children's Medical Center
- Medical College Of Wisconsin
- Universitair Ziekenhuis Gent - UZ GENT
- CHU de Bordeaux, Hopital des Enfants
- IHOPE - Hospices civils de Lyon
- Hopital trousseau- APHP
- Hôpital Robert Debré
- Hôpital D'Enfants
- Charite-Universitätsmedizin Berlin - Berlin
- Medizinische Hochschule Hannover
- Universitätsklinikum Münster
- Schneider Children's Medical Center
- Istituto Giannina Gaslini
- Fondazione MBBM, ASST Monza
- Ospedale Pediatrico Bambin Gesù
- AOU Città della Salute e della Scienza di Torino, Presidio Ospedale Infantile Regina Margherita
- Princess Maxima Center
- Hosp. Univ. Vall D Hebron
- Hosp. Sant Joan de Deu
- Hosp. Infantil Univ. Niño Jesus
- Hosp. Univ. I Politecni La Fe
- Karolinska University Hospital
- Bristol Royal Hospital for Children
- Royal Hospital for Sick Children
- Leeds Children's Hospital
- University College London Hospitals
- Great Ormond Street Hospital
- Royal Manchester Children's Hospital
- Royal Marsden Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cohort 1: B-Cell Acute Lymphoblastic Leukemia (ALL)/LL
Cohort 2: T-Cell 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.
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.