Status:
COMPLETED
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
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Eligibility:
All Genders
1-30 years
Phase:
PHASE2
Brief 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)/l...
Detailed Description
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, unaccept...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2022
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03384654
Start Date
May 14 2018
End Date
September 27 2022
Last Update
May 25 2025
Active Locations (53)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233-1711
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
4
Children's Hospital Orange County
Orange, California, United States, 92868