An Open-label Multicenter Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects >=1 and =30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Investigation of an investigational medication for treating pediatric and young adult leukemia and lymphoma
Brief description of study.
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: acute lymphoblastic leukemia
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Age: 1 years - 30 years
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Gender: All
Inclusion Criteria
Documented acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL)
Adequate hematology laboratory values at Cycle 1 Day 1 pre-dosing
Adequate renal function
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.
Known moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification. Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma may participate in the study.
Down syndrome, juvenile myelomonocytic leukemia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome.
Prior exposure to daratumumab or other anti-CD38 therapies.
Prior cancer immunotherapy (ie, CAR-T, inotuzumab) within 4 weeks prior to start of daratumumab treatment or blinatumomab within 2 weeks prior to the start of daratumumab treatment.
Known to be seropositive for human immunodeficiency virus, hepatitis B (defined by a positive test for hepatitis B surface antigen or antibodies to hepatitis B surface and core antigens), or hepatitis C (except in the setting of a sustained virologic response (SVR), defined as aviremia at least 12 weeks after completion of antiviral therapy).
Known allergies, hypersensitivity, or intolerance to mannitol, glucocorticoid, doxorubicin, cytarabine, methotrexate, vincristine, cyclophosphamide, 6-mercaptopurine, mAb (IRR is not considered hypersensitivity) or human proteins, or their excipients, or known sensitivity to mammalian-derived products.
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.
Pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of any component of the treatment regimen.
Plans to father a child while enrolled in this study or within 6 months after the last dose of any component of the treatment regimen.
Has any concurrent medical or psychiatric condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.
Major surgery within 2 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study or within 2 weeks after the last dose of study drug administration. Note: Subjects with planned surgical procedures to be conducted under local anesthesia may participate.
This study investigates the effectiveness of an investigational medication for treating children and young adults with acute lymphoblastic leukemia or lymphoblastic lymphoma. Acute lymphoblastic leukemia is a type of cancer that affects the blood and bone marrow, while lymphoblastic lymphoma is a similar cancer affecting lymph nodes. The study aims to understand how well this medication works for these conditions.
Participants in the study will undergo certain procedures, which may include receiving the investigational medication and having regular health check-ups to monitor their response to the treatment. The study will ensure that all participants meet specific health criteria before starting the treatment to ensure their safety throughout the process.
- Who can participate: Children and young adults aged 1 to 30 years with documented acute lymphoblastic leukemia or lymphoblastic lymphoma can participate. Key eligibility factors include having adequate laboratory values and renal function, and not having received certain treatments recently.
- Study details: Participants will receive the investigational medication and may be given a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. Participants will be closely monitored for their health and response to the treatment.