Chronic Lymphocytic LeukemiaNCT03375619
Long-term Follow-up Study of Patients Receiving CAR-T Cells
An observational study of Chronic Lymphocytic Leukemia and Lymphomas Non-Hodgkin's B-Cell, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This protocol is designed as a long-term follow-up study of participants who will receive CAR-T cells as part of a clinical trial at the Medical College of Wisconsin/ Froedtert Hospital. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Lymphomas Non-Hodgkin's B-Cell, Lymphoma, Small Lymphocytic
- What is being tested?
- Long-Term Follow-Up of Participants who Received CAR-T cells
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 1 Jan 2035
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants who enrolled in a CAR-T study at Froedtert Hospital \& the Medical College of Wisconsin.
Who may be able to join
- All participants who enrolled in a CAR-T study at Froedtert Hospital \& the Medical College of Wisconsin.
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Cancer Center Clinical Trials Office, 414-805-8900, cccto@mcw.edu
About this study
This protocol is designed as a long-term follow-up study of participants who will receive CAR-T cells as part of a clinical trial at the Medical College of Wisconsin/ Froedtert Hospital. The clinical trials include the following:
Phase 1 Study of CAR-20/19-T Cells in Patients with Relapsed Refractory B Cell Malignancies (NCT03019055); Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma (NCT05976555); CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies (NCT05094206); LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies (NCT05990465); CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (NCT04186520)
Read the detailed description
The objective is to follow participants receiving CAR-T cells from years 2 to 15 post-treatment for persistence of CAR-T cells, development of secondary malignancies, or other medical complications.
- Conditions
- Chronic Lymphocytic Leukemia, Lymphomas Non-Hodgkin's B-Cell, Lymphoma, Small Lymphocytic, Mantle Cell Lymphoma, Central Nervous System Lymphoma, Diffuse Large B Cell Lymphoma
- Being tested
- Long-Term Follow-Up of Participants who Received CAR-T cells
- Keywords
- CAR-T Cell Therapy, chimeric antigen receptor
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Burkitt Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-Term Follow-Up of Participants who Received CAR-T cellsOther
No study drug is administered in this study. Participants who received CAR-T cells in a previous trial will be evaluated in this trial for long-term safety and efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Participants who received CAR-T cells. | Participants who received CAR-T cells at Froedtert Hospital \& the Medical College of Wisconsin in clinical trials (e.g., NCT05976555, NCT05094206, NCT05990465, NCT03019055 or NCT04186520). Receives: Other: Long-Term Follow-Up of Participants who Received CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the incidence of a new malignancy at 5 years.
The number of subjects with new malignancy.
Measured: Baseline to five years.
Change from baseline in the incidence of a new malignancy at 10 years.
The number of subjects with new malignancy.
Measured: Baseline to 10 years.
Change from baseline in the incidence of a new malignancy at 15 years.
The number of subjects with new malignancy.
Measured: Baseline to 15 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start1 Dec 2017
- Primary completion1 Jan 2035 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nirav Shah, Medical College of Wisconsin
- Investigators
- Nirav Shah, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375619
- Sponsor's protocol ID
- PRO30317
- Status last verified
- Nov 2025
- First submitted
- 7 Dec 2017
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up Study of Patients Receiving CAR-T Cells
- ClinicalTrials.gov ID
- NCT03375619
- Acronym / sponsor ID
- PRO30317
- Conditions
- Chronic Lymphocytic Leukemia, Lymphomas Non-Hodgkin's B-Cell, Lymphoma, Small Lymphocytic, Mantle Cell Lymphoma, Central Nervous System Lymphoma, Diffuse Large B Cell Lymphoma
- Keywords
- CAR-T Cell Therapy, chimeric antigen receptor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Jan 2035 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 18 Dec 2017 (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 protocol is designed as a long-term follow-up study of participants who will receive CAR-T cells as part of a clinical trial at the Medical College of Wisconsin/ Froedtert Hospital. The clinical trials include the following:
Phase 1 Study of CAR-20/19-T Cells in Patients with Relapsed Refractory B Cell Malignancies (NCT03019055); Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma (NCT05976555); CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies (NCT05094206); LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies (NCT05990465); CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (NCT04186520)
Detailed description
The objective is to follow participants receiving CAR-T cells from years 2 to 15 post-treatment for persistence of CAR-T cells, development of secondary malignancies, or other medical complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants who received CAR-T cells. | – | Other: Long-Term Follow-Up of Participants who Received CAR-T cellsParticipants who received CAR-T cells at Froedtert Hospital \& the Medical College of Wisconsin in clinical trials (e.g., NCT05976555, NCT05094206, NCT05990465, NCT03019055 or NCT04186520). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants who enrolled in a CAR-T study at Froedtert Hospital \& the Medical College of Wisconsin.
Key inclusion criteria (1 listed)
- All participants who enrolled in a CAR-T study at Froedtert Hospital \& the Medical College of Wisconsin.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-Term Follow-Up of Participants who Received CAR-T cellsNo study drug is administered in this study. Participants who received CAR-T cells in a previous trial will be evaluated in this trial for long-term safety and efficacy. | Other | Participants who received CAR-T cells. |
Primary outcome
Change from baseline in the incidence of a new malignancy at 5 years.
Time frame: Baseline to five years.
The number of subjects with new malignancy.
Change from baseline in the incidence of a new malignancy at 10 years.
Time frame: Baseline to 10 years.
The number of subjects with new malignancy.
Change from baseline in the incidence of a new malignancy at 15 years.
Time frame: Baseline to 15 years.
The number of subjects with new malignancy.
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 10 Nov 2025.
- Individual participant dataSharing planned: No
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Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
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.
Nirav Shah principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia and Lymphomas Non-Hodgkin's B-Cell, run by Medical College of Wisconsin at 1 site 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 1 inclusion and 1 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 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Medical College of Wisconsin Clinical Cancer Center (414-805-8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the incidence of a new malignancy at 5 years. (time frame: Baseline to five years.). 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 10 Nov 2025.