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
You may be eligible for this study if you meet the following criteria:
- Conditions: acute lymphoblastic leukemia,lymphoblastic lymphoma
Age: Between 1 Years - 30 Years
Gender: Male or Female
Documented acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL)
Adequate hematology laboratory values at Cycle 1 Day 1 pre-dosing
Adequate renal function
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.Additional Information:
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