BridgeMD
New treatment option for Diffuse Large B Cell Lymphoma
Official title A Study of Ultra-fraction Radiotherapy Bridging CART in R/R DLBCL
ClinicalTrials.gov ID: NCT05514327
What this study is testing
- What it's testing
- This is a single-arm single center study to prospectively evaluate the safety and efficacy of ultra-fraction radiotherapy bridging CAR-T therapy in relapsed/refractory diffuse large b cell lymphoma
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
- Over than 18 years old
- Histologically confirmed DLBCL(by central pathology review before enrolment)
- Relapsed or refractory disease after ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed autologous Hematopoietic...
- Measurable disease at time of enrollment (the maximum diameter of cross section ≥1.5cm)
- Life expectancy ≥12 weeks
You likely can't join if
- Prior radiation therapy within 1 year of infusion
- Pregnant or nursing (lactating) women
- Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
- Previous solid tumor within 3 years, previous or concurrent hematological malignancy
- Severe organ dysfunction: left ventricle ejection fraction (LVEF) \ 3 ULN
- HIV positive patients, active replication of or prior infection with hepatitis B or active hepatitis C( HCV RNA positive );
See the full eligibility criteria
- Over than 18 years old
- Histologically confirmed DLBCL(by central pathology review before enrolment)
- Relapsed or refractory disease after ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT), or being ineligible for or not...
- Measurable disease at time of enrollment (the maximum diameter of cross section ≥1.5cm)
- Life expectancy ≥12 weeks
- Able to receive radiotherapy evaluated by specialist
- Prior radiation therapy within 1 year of infusion
- Pregnant or nursing (lactating) women
- Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
- Previous solid tumor within 3 years, previous or concurrent hematological malignancy
- Severe organ dysfunction: left ventricle ejection fraction (LVEF) \ 3 ULN
- HIV positive patients, active replication of or prior infection with hepatitis B or active hepatitis C( HCV RNA positive );
- Other conditions that the investigator may exclude due to risks or other possibilities
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
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 Beijing, Beijing Municipality, China. 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.