BridgeMD
New treatment option for Large B-cell Lymphoma
Official title Single-Arm Comprehensive Ablative Bridging Irradiation I Prior to CD19 CAR-T In High-Risk R/R LBCL
ClinicalTrials.gov ID: NCT06104592
What this study is testing
What is Chimeric Antigen Receptor T-Cell Therapy?
Chimeric Antigen Receptor T-Cell Therapy is an investigational medicine, being studied as a potential treatment for large b-cell lymphoma.
Also referred to as Axi-Cel, Yascarta.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 2, single-arm, open-label study to evaluate the safety and efficacy of comprehensive bridging radiation therapy prior to CD19 CAR T-cell therapy for large B-cell lymphoma patients with bulky disease, defined as any lesion ≥5 cm.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with a histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) who plan to receive treatment at the Moffitt Cancer...
- Must have ability to comprehend and the willingness to sign written informed consent for study participation.
- Eligible to receive CAR T-cell therapy (axicabtagene ciloleucel) for LBCL and histological variants approved by the standard of care label
- ECOG performance status 0 to 2.
- At least one high-risk lesion, defined as measuring ≥ 5 cm, that is targetable for radiotherapy per investigator assessment.
You likely can't join if
- Patients who are currently receiving or who have received any other investigational study agent ≤4 weeks prior to screening visit are ineligible
- Prior treatment with chimeric antigen receptor (CAR) T-cell therapy
- Inability to safely deliver comprehensive radiation therapy to all sites of disease per treating radiation oncologists' discretion
- Participants with clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from...
- Participants with arrhythmias that are not stable on a medical management program within 2 weeks of screening are also excluded.
- Evidence of active uncontrolled/untreated infection (viral, bacterial, fungal, opportunistic) of any origin.
See the full eligibility criteria
- Patients with a histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) who plan to receive treatment at the Moffitt Cancer Center will be eligible.
- Must have ability to comprehend and the willingness to sign written informed consent for study participation.
- Eligible to receive CAR T-cell therapy (axicabtagene ciloleucel) for LBCL and histological variants approved by the standard of care label
- ECOG performance status 0 to 2.
- At least one high-risk lesion, defined as measuring ≥ 5 cm, that is targetable for radiotherapy per investigator assessment.
- Ability to undergo comprehensive bridging radiation, defined as radiation to all visible sites of disease.
- No evidence or suspicion of active central nervous system (CNS) involvement of lymphoma
- Adequate bone marrow and organ function as defined in protocol. The effects of therapeutic agents used in this trial on developing human fetus are unknown, and because of this, women of child-bearing potential and men...
- Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through safety follow up and must refrain from donating sperm during this period. Permitted methods...
- Women of childbearing potential must have a negative serum or urine pregnancy test at screening and at time of radiation treatment planning, per standard of care and departmental standard operating procedure. Patients...
- Women of non-childbearing potential (i.e., surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥12 months of amenorrhea) are eligible.
- Patients who are currently receiving or who have received any other investigational study agent ≤4 weeks prior to screening visit are ineligible
- Prior treatment with chimeric antigen receptor (CAR) T-cell therapy
- Inability to safely deliver comprehensive radiation therapy to all sites of disease per treating radiation oncologists' discretion
- Participants with clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from screening, New York Health Association III or IV heart failure, and...
- Participants with arrhythmias that are not stable on a medical management program within 2 weeks of screening are also excluded.
- Evidence of active uncontrolled/untreated infection (viral, bacterial, fungal, opportunistic) of any origin.
- Known positive Human immunodeficiency virus (HIV) status.
- Participants with evidence of active and/or chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection, HCV must have a negative nucleic acid test post-treatment or spontaneous clearance.
- Participants who require the concurrent use of chronic systemic steroids or immunosuppressant medications. Steroids should not be given within 5 days prior to leukapheresis. Concomitant bridging steroids (Section 6.6)...
- Any condition that would, in the investigator's judgement, interfere with full participation in the study and attending required study visits (if outpatient); pose a significant risk to the participant; or interfere...
- In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation including ability...
- Women of childbearing potential who are pregnant or breastfeeding. Females who have undergone surgical sterilization or who have been postmenopausal for at least 12 months are not considered to be of childbearing...
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.