NCT05800405ToborozKorai 1. fázis
Evaluation of Bridging Radiation Therapy Before CAR T-Cell Infusion for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma
A Feasibility Study of Bridging Radiation to All Sites of FDG-Avid Disease for Commercial CAR T-Cell Infusion in Patients With Large B-Cell Lymphoma
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. febr. 4.
Rövid összefoglaló (regiszter, angolul)
This early phase I clinical trial evaluates bridging radiation therapy given before chimeric antigen receptor (CAR) T-cell infusion to treat large B-cell lymphoma (LBCL) that has come back (relapsed) or has not responded to previous treatment (refractory). Patients with relapsed or refractory disease have historically poor prognosis. CAR T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood (leukapheresis). Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T-cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. While the outcomes from CAR T-cell therapy appear favorable, in the time between leukapheresis and CAR T-cell infusion many patients have symptomatic or life-threatening disease which often requires bridging therapy. Bridging therapy aims to slow disease progression and control symptoms during this critical period prior to CAR T-cell infusion. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells. Giving bridging radiation therapy to patients with relapsed or refractory LBCL prior to CAR T-cell infusion may improve treatment outcomes with minimal toxicity.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- Korai 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 9 (tervezett)
- Első benyújtás
- 2023. márc. 24.
- Kezdés
- 2023. júl. 20.
- Elsődleges befejezés
- 2027. jan. 4.
- Fő szponzor
- City of Hope Medical Center
- Betegségek
- Diffúz nagy B-sejtes limfóma (DLBCL)
- NCT-szám
- NCT05800405
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · Korai 1. fázis
- Tervezett résztvevők: 9
- 2023. júl. 20. és az elsődleges befejezés (2027. jan. 4.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Prior CD19-directed therapy.
- Radiation therapy within 21 days prior to day 1 of protocol therapy.
Más betegség
- Central nervous system (CNS) disease.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
- Clinically significant uncontrolled illness.
- Active infection requiring antibiotics.
- Other active malignancy.
- Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
Egyéb
- Active diarrhea.
- Females only: Pregnant.
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
Kiket keres a vizsgálat
- Documented informed consent of the participant and/or legally authorized representative.
- Assent, when appropriate, will be obtained per institutional guidelines.
- Age: >= 18 years.
- Eastern Cooperative Oncology Group (ECOG) =< 2 or Karnofsky Performance Status (KPS) >= 60.
- Histologically confirmed large B-cell lymphoma.
- Relapsed/refractory disease.
- Planned to undergo commercial CAR T-cell infusion within 3 months of enrollment.
- 6 or fewer sites (treatable with a maximum of 3 isocenters) of FDG-PET avid disease, treatable with a a maximum of 3 isocenters.
- Measurable disease e.g., at least 1.5 cm on CT/MRI or by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).
- Fully recovered from the acute toxic effects (except alopecia) to =< grade 1 to prior anti-cancer therapy.
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (performed within 30 days prior to day 1 of protocol therapy).
- If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
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| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| City of Hope Medical Center | Duarte | Egyesült Államok | Toboroz |
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