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New treatment option for Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL)
Official title Integrated Radiotherapy-optimized ASCT Sequential CAR-T Therapy for Patients With Relapsed and Refractory B-NHL
ClinicalTrials.gov ID: NCT07059741
What this study is testing
- What it's testing
- This study aims to investigate a novel therapeutic strategy of integrated radiotherapy before autologous stem cell transplantation (ASCT) sequential chimeric antigen receptor T-cell(CAR-T) therapy for patients with relapsed/refractory(R/R) aggressive B-cell non-Hodgkin lymphoma (B-NHL). By evaluating the efficacy and safety of this multimodal approach, we seek to provide a theoretical foundation and clinical data to optimize outcomes for relapsed/refractory aggressive B-NHL patients.
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
- Age ≥18 years.
- Histologically confirmed aggressive B-NHL.
- Life expectancy \>3 months.
- Appropriate organ function: Cardiac function: cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and glutamic aminotransferase...
- Adequate bone marrow reserve defined as: hemoglobin ≥90 g/L. platelet count ≥70 x 10\^9/L. absolute neutrophil count ≥1.5 x 10\^9/L.
You likely can't join if
- severe hepatic and renal function abnormalities (alanine aminotransferase, bilirubin, creatinine \> 2 times the upper limit of normal);
- Presence of organic heart disease with resulting clinical symptoms or abnormal cardiac function (NYHA cardiac function classification ≥ grade 2);
- ECG QTc interval \>500 ms;
- active hepatitis B/hepatitis C;
- uncontrolled active infection;
- human immunodeficiency virus infection;
See the full eligibility criteria
- Age ≥18 years.
- Histologically confirmed aggressive B-NHL.
- Life expectancy \>3 months.
- Appropriate organ function: Cardiac function: cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and glutamic aminotransferase ≤ 2 times the upper limit of normal values; renal function: serum...
- Adequate bone marrow reserve defined as: hemoglobin ≥90 g/L. platelet count ≥70 x 10\^9/L. absolute neutrophil count ≥1.5 x 10\^9/L.
- The patient is capable of understanding and willing to provide written informed consent.
- people of childbearing or childbearing potential must be willing to practice birth control from the date of enrollment in this study until study follow-up.
- severe hepatic and renal function abnormalities (alanine aminotransferase, bilirubin, creatinine \> 2 times the upper limit of normal);
- Presence of organic heart disease with resulting clinical symptoms or abnormal cardiac function (NYHA cardiac function classification ≥ grade 2);
- ECG QTc interval \>500 ms;
- active hepatitis B/hepatitis C;
- uncontrolled active infection;
- human immunodeficiency virus infection;
- concurrent other tumors requiring treatment or intervention;
- current or anticipated need for systemic corticosteroid therapy;
- pregnant or lactating women;
- abandonment of consolidation autologous hematopoietic stem cell transplantation for financial reasons;
- other psychological conditions that prevent the patient from participating in the study or signing the informed consent form;
- people who, in the judgment of the investigator, are unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or do not meet the requirements for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, 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 Suzhou, Jiangsu, 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.