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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

Recruiting
1-30 years
All
Phase N/A

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.
Study details
    acute lymphoblastic leukemia

TX9370

19 February 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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