A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participa… (NCT03384654) | Clinical Trial Compass
CompletedPhase 2
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
United States47 participantsStarted 2018-05-14
Plain-language 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.
Who can participate
Age range1 Year – 30 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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)
✓. 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
✕. Evidence of dyspnea at rest or oxygen saturation (\<=) 94 percent (%).
What they're measuring
1
Cohort 1: Percentage of Participants With Complete Response (CR) for B-cell Acute Lymphoblastic Leukemia (ALL)
Timeframe: Up to 2 cycles, that is, up to 56 days (each cycle of 28-days)
2
Cohort 2: Percentage of Participants With Complete Response (CR) for T-cell ALL
Timeframe: End of Cycle 1 (that is, up to 28 days)
✕. Known moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification
✕. 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)