UPCC 39424 An Observational Long-term Follow-up Study of Patients Who Received Prior Caribou Cell Therapy (LTFS)
Investigation of Long-term Safety in Patients from Investigational Cell Therapy Studies
Brief description of study
This is an observational, non-interventional, LTFS of investigational Caribou therapies in patients who have participated in a parent study: a prior Caribou-sponsored clinical study, special access program, or an IIT. The objective is to evaluate the long-term safety, through 15 years post infusion, in patients who received IPs in a Caribou-sponsored clinical study, special access program or IIT.
Detailed description of study
This is an observational, non-interventional, LTFS of investigational Caribou therapies in patients who have participated in a parent study: a prior Caribou-sponsored clinical study, special access program, or an IIT. The objective is to evaluate the long-term safety, through 15 years post infusion, in patients who received IPs in a Caribou-sponsored clinical study, special access program or IIT.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Lymphoma, Non-Hodgkin, Relapsed Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Lymphoma, B Cell Lymphoma, B-Cell Non-Hodgkin's Lymphoma, Hematologic Malignancy, Relapsed/Refractory Multiple Myeloma, Relapsed/Refractory Acute Myeloid Leukemia
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Age: 18 years or above
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Gender: All
Inclusion Criteria:
- Written informed consent (by patient or legal representative) obtained prior to study-specific activities/enrollment
- Completed a Caribou-sponsored study or was administered Caribou IP under a special access program or as part of an IIT
- Use of an effective method of birth control by women of childbearing potential and their partners and men with partners of childbearing potential (partners must also use an effective birth control method) through 12 months post IP infusion.
Exclusion Criteria:
- None
This study investigates the long-term safety of investigational cell therapies in patients who have previously participated in Caribou-sponsored clinical studies, special access programs, or investigator-initiated trials (IITs). The purpose of this study is to observe patients over a period of up to 15 years after they have received their initial treatment, to ensure that the therapies remain safe over time. An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment.
Participants in this study will not undergo any new interventions or treatments. Instead, researchers will collect data from routine medical care and follow-up visits to monitor the long-term effects of the investigational therapies. This approach allows for the collection of important safety data while minimizing the burden on participants.
- Who can participate: Participants must have completed a Caribou-sponsored study or received investigational therapy under a special access program or IIT. Women of childbearing potential and their partners must use effective birth control for 12 months post-treatment.
- Study details: Participants will be observed over time without any additional interventions. Data will be collected from routine medical care to monitor safety.
- Study timelines: The study will last 15 years post-infusion.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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