Clinical trial NCT05865301: Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy
Official title: Outcomes in Pediatric and Young Adult B-Cell Malignancies After Commercially Available Immunotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoid Leukemia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Pediatric Oncology Experimental Therapeutic Investigators Consortium
First posted: 2023-05-18
Enrollment: 500
Sex: ALL
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Both Arm A and Arm B, includes retrospective and prospective data collection for patients experiencing refractory disease or first relapse, who have not received immunotherapy and are not yet being considered for immunotherapy. Retrospective data collection will parallel Arm A and patients will not require consent or assent. Prospective data collection will parallel Arm B and will require patient consent and assent as relevant

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.


Eligibility 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.

Primary outcomes:
measure: WECARE-Survey
timeFrame: at baseline
measure: Retrospective WECARE Survey
timeFrame: up to 12 months post infusion
Secondary outcomes:
measure: overall survival (OS)
timeFrame: at baseline up to 12 months post infusion
measure: event-free-survival (EFS)
timeFrame: at baseline up to 12 months post infusion
measure: duration of remission (DOR)
timeFrame: at baseline up to 12 months post infusion
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Liora Schultz, M.D
role: PRINCIPAL_INVESTIGATOR
References: