Skip to main content

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

Trial Status: Active

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.

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)

Colorado

Aurora
Children's Hospital Colorado
Status: ACTIVE

Georgia

Atlanta
Children's Healthcare of Atlanta - Egleston
Status: APPROVED

Illinois

Chicago
Northwestern University
Status: ACTIVE

Indiana

Indianapolis
Riley Hospital for Children
Status: ACTIVE
Contact: Anne Bubnick
Phone: 317-948-0101

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: APPROVED

Massachusetts

Boston
Boston Children's Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Brigham and Women's Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Dana-Farber Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

Ohio

Columbus
Nationwide Children's Hospital
Status: ACTIVE

Pennsylvania

Philadelphia
Children's Hospital of Philadelphia
Status: ACTIVE

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Marcella West Aguilar
Phone: 214-648-1479
Houston
Texas Children's Hospital
Status: IN_REVIEW

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 8 weeks until subsequent anticancer therapy is initiated.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Janssen Research & Development, LLC

  • Primary ID CR108432
  • Secondary IDs NCI-2018-01537, 54767414ALL2005, 2017-003377-34
  • Clinicaltrials.gov ID NCT03384654