B-ALLNCT06579469
Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy
An observational study of B-ALL and Hematologic Malignancy, run by St. Jude Children's Research Hospital at 7 sites in United States.
Trial summary
This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and/or have damage to the nervous system. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- B-ALL, Hematologic Malignancy, Solid Tumor
- How many people
- 100 participants
- Where
- 7 sitesUnited States
- Study dates
- 20 Jan 2026to Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants who have received CAR T cell therapy for an oncologic diagnosis
Who may be able to join
- Participants must have received an initial systemically-administered CAR T cell infusion for an oncologic diagnosis within the last 1-3 months (+/- 14 days).
- Initial infusion is defined as the first administration of a CAR T cell product the participant has not previously received OR receipt of a CAR T cell product previously received after an interval allogeneic HSCT.
- Age ≤ 30 years at CAR T cell infusion.
Who cannot join
- Active malignancy other than the disease under study.
- Planned consolidative HSCT within 3 months post CAR T cell infusion.
- Received or planned additional disease directed therapy post CAR T cell infusion.
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Childrens Hospital of Colorado
Aurora, Colorado, 80045
Hesham Eissa, MD, MSc, 720-777-4151, hesham.eissa@childrenscolorado.org
Hesham Eissa, MD, MSc
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Emily Hsieh, MD, 323-361-5036, ehsieh@chla.usc.edu
Emily Hsieh, MD
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Rebecca Epperly, MD, 888-226-4343, referralinfo@stjude.org
Rebecca Epperly, MD
- Recruiting
Children's Hospital of Wisconsin.
Milwaukee, Wisconsin, 53226
Amy Moskop, MD, 414-955-4142, amoskop@mcw.edu
Amy Moskop, MD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Regina Myers, MD, 215-590-1000, Myersm@chop.edu
Regina Myers, MD
- Recruiting
Primary Children's Hospital
Salt Lake City, Utah, 84113
Joseph G. Dolan, MD, 801-662-4700, gregory.dolan@hsc.utah.edu
Joseph G Dolan, MD
- Recruiting
Seattle Childrens Hospital
Seattle, Washington, 98105
Mallory Taylor, MD, 206-884-1582, molly.taylor@seattlechildrens.org
Mallory Taylor, MD
About this study
Official title: Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy (PROSPER)
This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and/or have damage to the nervous system.
Read the detailed description
Primary Objectives
- Bone Marrow Function: To report on the incidence, timing, severity of, and risk factors for bone marrow dysfunction in participants in remission or without bone marrow involvement of disease at 3- and 6-months following CAR T cell therapy. (B-ALL cohort)
- Infection/Immune Reconstitution: To evaluate the incidence, timing, severity of and risk factors for clinically significant infections following CAR T cell therapy at 3- and 6-months following CAR T cell therapy. (B-ALL cohort)
- Neurotoxicity: To evaluate the incidence, timing, severity of, and risk factors for persistent ICANS at 3- and 6-months post CAR T cell therapy. (B-ALL cohort)
Secondary Objectives
- To evaluate bone marrow function, infection/immune reconstitution, and neurotoxicity at 12 months and 24 months post CAR T cell therapy in participants with B-ALL.
- To characterize bone marrow function, infection/immune reconstitution, and neurotoxicity between 3 and 24 months after CAR T cell therapy in other hematologic malignancies and solid tumor cohorts.
Participants will have an assessment of preexisting morbidity and potential risk factors, collection of specimens for banking, scheduled late effects monitoring, laboratory analysis, and screening studies. Data and biospecimens will be collected at 3 months, 6 months, 1 year and 2 years after CAR T cell infusion.
- Conditions
- B-ALL, Hematologic Malignancy, Solid Tumor
- Keywords
- CAR T cell infusion, Late Effects
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| B cell acute lymphoblastic leukemia (B cell acute lymphoblastic leukemia (B-ALL) ) cohort | B-ALL participants who have received initial CAR T cell therapy within the last 1-3 months. | |
| Other hematologic malignancy | Other hematologic malignancy participants who have received initial CAR T cell therapy within the last 1-3 months. | |
| Solid tumor (ST) | ST participants who have received initial CAR T cell therapy within the last 1-3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of bone marrow dysfunction (BMD)
Among patients in remission or without bone marrow involvement of disease in the B-ALL cohort, we will summarize the rates of prevalent BMD at 3- and 6-months post-infusion and estimate the cumulative incidence of new BMD and BMD recovery for patients with prevalent BMD at 3- and 6-months.
Measured: Within 6 months post CAR T-cell therapy
Occurrence of clinically significant infections
The infection density of clinically significant infections in 3-6 months will be summarized in the B-ALL cohort.
Measured: Within 6 months post CAR T-cell therapy
Presence of persistent ICANS
We will summarize the rates of persistent ICANS at 3- and 6-months post-infusion and estimate the cumulative incidence and timing of new ICANS and ICANS recovery for patients with persistent ICANS at 3- and 6-months in the B-ALL cohort.
Measured: Within 6 months post CAR T-cell therapy
Secondary outcomes (7)
Presence of bone marrow dysfunction (BMD)
Among patients in remission or without bone marrow involvement of disease in the B-ALL cohort, we will summarize the rates of prevalent BMD at 12- and 24-months post-infusion and estimate the cumulative incidence of new BMD and BMD recovery for patients with prevalent BMD at 12- and 24-months. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts.
Measured: Within 24 months post CAR T-cell therapy
Severity of BMD
The highest severity BMD for each patient will be recorded. The severity of BMD in the B-ALL cohort will be described using descriptive statistics. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts.
Measured: Within 24 months post CAR T-cell therapy
Occurrence of clinically significant infections
The infection density of clinically significant infections within 24 months will be summarized in the B-ALL cohort. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts.
Measured: Within 24 months post CAR T-cell therapy
Time to the earliest clinically significant infection
The time from 3 months post-infusion to the first clinically significant post-infusion within 24 months post-infusion will be summarized in the B-ALL cohort. The cumulative incidence of the first clinically significant infection post-infusion within 24 months will be estimated in B-ALL cohort. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts.
Measured: Within 24 months post CAR T-cell therapy
Severity of clinically significant infections
The highest severity among all clinically significant infections for each patient will be summarized. The severity of clinically significant infections in the B-ALL cohort will be described. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts.
Measured: Within 24 months post CAR T-cell therapy
Presence of persistent ICANS
We will summarize the rates of persistent ICANS at 12- and 24-months post-infusion and estimate the cumulative incidence and timing of new ICANS and ICANS recovery for patients with persistent ICANS at 12- and 24-months in B-ALL cohort. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts.
Measured: Within 24 months post CAR T-cell therapy
Severity of persistent ICANS
The highest severity of ICANS for each patient will be recorded. The severity of ICANS in the B-ALL cohort will be described using descriptive statistics. Analyses will be replicated in the other hematologic malignancies and solid tumor cohorts.
Measured: Within 24 months post CAR T-cell therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start20 Jan 2026
- Primary completionJan 2029 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-ALLStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rally Foundation for Childhood Cancer Research
- Responsible party
- Sponsor
- Investigators
- Rebecca Epperly, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579469
- Sponsor's protocol ID
- PROSPER
- Other IDs
- NCI-2024-06836
- Status last verified
- Nov 2026
- First submitted
- 28 Aug 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy (PROSPER)
- ClinicalTrials.gov ID
- NCT06579469
- Acronym / sponsor ID
- PROSPER
- Conditions
- B-ALL, Hematologic Malignancy, Solid Tumor
- Keywords
- CAR T cell infusion, Late Effects
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- Rally Foundation for Childhood Cancer Research
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and/or have damage to the nervous system.
Detailed description
Primary Objectives
- Bone Marrow Function: To report on the incidence, timing, severity of, and risk factors for bone marrow dysfunction in participants in remission or without bone marrow involvement of disease at 3- and 6-months following CAR T cell therapy. (B-ALL cohort)
- Infection/Immune Reconstitution: To evaluate the incidence, timing, severity of and risk factors for clinically significant infections following CAR T cell therapy at 3- and 6-months following CAR T cell therapy. (B-ALL cohort)
- Neurotoxicity: To evaluate the incidence, timing, severity of, and risk factors for persistent ICANS at 3- and 6-months post CAR T cell therapy. (B-ALL cohort)
Secondary Objectives
- To evaluate bone marrow function, infection/immune reconstitution, and neurotoxicity at 12 months and 24 months post CAR T cell therapy in participants with B-ALL.
- To characterize bone marrow function, infection/immune reconstitution, and neurotoxicity between 3 and 24 months after CAR T cell therapy in other hematologic malignancies and solid tumor cohorts.
Participants will have an assessment of preexisting morbidity and potential risk factors, collection of specimens for banking, scheduled late effects monitoring, laboratory analysis, and screening studies. Data and biospecimens will be collected at 3 months, 6 months, 1 year and 2 years after CAR T cell infusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B cell acute lymphoblastic leukemia (B cell acute lymphoblastic leukemia (B-ALL) ) cohort | – | –B-ALL participants who have received initial CAR T cell therapy within the last 1-3 months. |
| Other hematologic malignancy | – | –Other hematologic malignancy participants who have received initial CAR T cell therapy within the last 1-3 months. |
| Solid tumor (ST) | – | –ST participants who have received initial CAR T cell therapy within the last 1-3 months. |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants who have received CAR T cell therapy for an oncologic diagnosis
Key inclusion criteria (3 listed)
- Participants must have received an initial systemically-administered CAR T cell infusion for an oncologic diagnosis within the last 1-3 months (+/- 14 days).
- Age ≤ 30 years at CAR T cell infusion.
Key exclusion criteria (4 listed)
- Active malignancy other than the disease under study.
- Planned consolidative HSCT within 3 months post CAR T cell infusion.
- Received or planned additional disease directed therapy post CAR T cell infusion.
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of bone marrow dysfunction (BMD)
Time frame: Within 6 months post CAR T-cell therapy
Among patients in remission or without bone marrow involvement of disease in the B-ALL cohort, we will summarize the rates of prevalent BMD at 3- and 6-months post-infusion and estimate the cumulative incidence of new BMD and BMD recovery for patients with prevalent BMD at 3- and 6-months.
Occurrence of clinically significant infections
Time frame: Within 6 months post CAR T-cell therapy
The infection density of clinically significant infections in 3-6 months will be summarized in the B-ALL cohort.
Presence of persistent ICANS
Time frame: Within 6 months post CAR T-cell therapy
We will summarize the rates of persistent ICANS at 3- and 6-months post-infusion and estimate the cumulative incidence and timing of new ICANS and ICANS recovery for patients with persistent ICANS at 3- and 6-months in the B-ALL cohort.
7 secondary outcomes
Presence of bone marrow dysfunction (BMD)
Time frame: Within 24 months post CAR T-cell therapy
Severity of BMD
Time frame: Within 24 months post CAR T-cell therapy
Occurrence of clinically significant infections
Time frame: Within 24 months post CAR T-cell therapy
Time to the earliest clinically significant infection
Time frame: Within 24 months post CAR T-cell therapy
Severity of clinically significant infections
Time frame: Within 24 months post CAR T-cell therapy
Presence of persistent ICANS
Time frame: Within 24 months post CAR T-cell therapy
Severity of persistent ICANS
Time frame: Within 24 months post CAR T-cell therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca Epperly, MD principal investigator
St. Jude Children's Research Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of B-ALL and Hematologic Malignancy, run by St. Jude Children's Research Hospital at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Epperly, MD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of bone marrow dysfunction (BMD) (time frame: Within 6 months post CAR T-cell therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.