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

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

Stanford University · NCT05865301

This study is testing how well two immunotherapy treatments work for children and young adults with B-cell cancers, like leukemia and lymphoma, by collecting their experiences and outcomes.

Quick facts

Study typeObservational
Enrollment500 (estimated)
AgesN/A to 26 Years
SexAll
SponsorStanford University (other)
Drugs / interventionsblinatumomab, inotuzumab, chemotherapy, immunotherapy
Locations21 sites (Tucson, Arizona and 20 other locations)
Trial IDNCT05865301 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include children and young adults aged 0 to 26 with B-cell precursor acute lymphoblastic leukemia or B-cell lymphoma, particularly those who have experienced refractory or relapsed disease.

Not a fit: Patients who are older than 26 years or those with other types of malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve understanding of the effectiveness of immunotherapy in treating B-cell malignancies in pediatric and young adult populations.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in treating B-cell malignancies, indicating potential for success in this study.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Tucson, Arizona and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Lymphoid Leukemia, PRWCC, Foresight

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.