Evaluating outcomes in young patients with B-cell cancers receiving immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to analyze the outcomes of children and young adults with B-cell malignancies who are treated with commercially available immunotherapies, specifically blinatumomab and inotuzumab ozogamicin. It employs a standardized platform to collect data both retrospectively and prospectively, focusing on patients with B cell precursor acute lymphoblastic leukemia (ALL) or B cell lymphoma. Participants will complete questionnaires to provide insights into their treatment experiences and outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Banner University Medical Center - Tucson
  Tucson, Arizona, United States Recruiting
• City of Hope Comprehensive Cancer Center
  Duarte, California, United States Recruiting
• Stanford University
  Palo Alto, California, United States Recruiting
• UCSF (Benioff Children's)
  San Francisco, California, United States Recruiting
• Nemours Children's Hospital
  New Castle, Delaware, United States Recruiting
• University of Florida Health Science Center - Gainesville
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Kara Davis, MD — Stanford University
• Study coordinator: Khanh Nguyen
• Email: khanhpn@stanford.edu
• Phone: (650) 721-2372

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.