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NCT05865301 | RECRUITING | Lymphoid Leukemia

Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy
Sponsor:

Stanford University

Brief Summary:

To use a consistent and standardized platform to retrospectively and prospectively study children and young adults with B cell malignancies receiving Immunotherapy, blinatumomab and/or inotuzumab ozogamicin.

Condition or disease

Lymphoid Leukemia

Intervention/treatment

Questionnaire for patients receiving therapy

Study Type : OBSERVATIONAL
Estimated Enrollment : 500 participants
Official Title : Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy
Actual Study Start Date : 2023-06-29
Estimated Primary Completion Date : 2025-08-30
Estimated Study Completion Date : 2025-08-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: to 26 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria (Arm A)
  • \* Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma
  • Who either
    • * Experienced refractory or relapsed disease, treated with standard chemotherapy, without immunotherapy treatment.
    • OR
    • * Previously undergone standard of care immunotherapy with FDA approved therapies, such as Kymriah™ (CTL019, tisagenlecleucel), blinatumomab or
    • * Age: Greater than or equal to 0 year of age and less than or equal to 26 years of age.
    • Inclusion Criteria (Arm B)
    • * Disease Status - B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma
    • * Age: Greater than or equal to 0 year of age and less than or equal to 26 years of age
    • * Patients who are either
      • * Undergoing evaluation for leukapheresis for planned standard of care tisagenlecleucel therapy, or planned for therapy with blinatumomab or inotuzumab. (Patients who received prior tisagenlecleucel, blinatumomab or inotuzumab on an established clinical trial and are now scheduled for commercial CAR, blinatumomab or inotuzumab therapy are also eligible) Or
      • * Experienced refractory or relapsed B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma
      • * Ability to give informed consent. All subjects ≥ 18 years of age must be able to give informed consent or have legal authorized representative (LAR) (i.e. parent or guardian) to consent, if not in capacity to give consent independently. For subjects \<18 years old their LAR must give informed consent. Pediatric subjects will be included in age appropriate discussion and written assent will be obtained for those \> 7 years of age, when appropriate, according to institutional procedures.
    • Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy

    Location Details

    NCT05865301

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    How to Participate

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    Locations

    RECRUITING

    United States, California

    Stanford University

    Palo Alto, California, United States, 94305