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New treatment option for DLBCL - Diffuse Large B Cell Lymphoma
Official title Optimizing lymphoDepletion to Improve Outcomes In Patients Receiving Cell Therapy With Yescarta
ClinicalTrials.gov ID: NCT05950802
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, being studied as a potential treatment for dlbcl - diffuse large b cell lymphoma.
Also referred to as cytoxin, neosar.
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 1b study of participants with Diffuse Large B Cell Lymphoma (DLBCL). The purpose of this study is to identify an optimized lymphodenpletion (LD) regimen by evaluating standard and intermediate doses of Fludarabine (Flu) / Cyclophosphamide (Cy) with or without a fixed dose of total lymphoid irradiation (TLI) in the setting of standard of care CAR T cell therapy.
- Phase 1: an early, usually small safety study
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 at the time of informed consent
- Life expectancy ≥ 12 weeks
- Biopsy-proven and histologically confirmed R/R large B cell lymphoma, including R/R DLBCL, transformation from FL, and R/R PMBCL.
- Radiographically documented measurable disease as per Lugano response criteria (i.e. LDi \> 1.5 cm that is FDG avid).
- At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic cancer therapy at the time the subject provides...
You likely can't join if
- Persisting disease bulk (defined as ≥10 cm) on restaging imaging following bridging therapy.
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years
- History of Richter's transformation of CLL
- History of allogeneic stem cell transplant
- Received \< 2 lines of therapy for large B cell lymphoma
- Prior CD19 targeted therapy
See the full eligibility criteria
Who can join
- Age ≥ 18 years at the time of informed consent
- Life expectancy ≥ 12 weeks
- Biopsy-proven and histologically confirmed R/R large B cell lymphoma, including R/R DLBCL, transformation from FL, and R/R PMBCL.
- Radiographically documented measurable disease as per Lugano response criteria (i.e. LDi \> 1.5 cm that is FDG avid).
- At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic cancer therapy at the time the subject provides consent
- Eligible for standard of care CAR T cell therapy, specifically, relapsed or refractory large B cell lymphoma after two or more lines of systemic therapy, and people must have received adequate first-line therapy...
- Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and
- An anthracycline containing chemotherapy regimen
- Patient does not have active CNS disease
- Patient is sufficiently stable to facilitate planned CAR T-cell therapy (e.g. not rapidly progressing on temporizing therapy, no significant compromise of vital organ functions (intubation, dialysis, requiring...
- ECOG performance status 0 or 1 at enrollment
- Patient has not received prior adoptive T-cell immunotherapy
- Patient is not HIV positive
- Patient did not receive prior allogeneic stem cell transplant
- Adequate bone marrow, renal, hepatic, pulmonary and cardiac function
- Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of...
- Sexually active males who accept to use a condom during intercourse during treatment and for 6 months after treatment as they should not father a child in this period. A condom is required to be used also by...
- Must have an apheresis product of non-mobilized cells accepted for manufacturing.
What rules you out
- Persisting disease bulk (defined as ≥10 cm) on restaging imaging following bridging therapy.
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years
- History of Richter's transformation of CLL
- History of allogeneic stem cell transplant
- Received \< 2 lines of therapy for large B cell lymphoma
- Prior CD19 targeted therapy
- Subject has received or undergone the following: o Therapeutic doses of corticosteroids (defined as \>20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis. Physiologic steroid replacement, topical...
- Cytotoxic chemotherapeutic agents that are not considered lymphotoxic, and intrathecal (IT) chemotherapy must be stopped ≥ 7 days prior to leukapheresis.
- Lymphotoxic chemotherapeutic agents (eg, cyclophosphamide \> 300 mg/m2, ifosfamide, bendamustine) 4 weeks prior to leukapheresis.
- Experimental agents within 4 weeks prior to signing the ICF, unless no response or PD is documented on the experimental therapy and at least 5 half-lives have elapsed prior to leukapheresis.
- Ibrutinib, lenalidomide and PI3K inhibitor within 5 half-lives prior to leukapheresis
- Immunosuppressive therapies within 4 weeks prior to leukapheresis (eg, calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate, rapamycin thalidomide, immunosuppressive antibodies such as...
- Radiation within 6 weeks of leukapheresis. Subject must have progressive disease in irradiated lesions or have additional nonirradiated, PET-positive lesions to be eligible. Radiation to a single lesion, if additional...
- Treatment with systemic immunostimulatory agents (including but not limited to interferon and IL-2) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to the infusion of axicabtagene ciloleucel
- Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy
- Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are...
- Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the...
- Active tuberculosis
- Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters such as a...
- people with detectable cerebrospinal fluid malignant cells or known CNS involvement; a history of prior treated CNS lymphoma which is not active at the time of relapse is permitted
- History or presence of significant non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
- people with cardiac atrial or cardiac ventricular lymphoma involvement
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac disease within 12...
- Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression
- History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest computed tomography (CT)...
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment
- Any medical condition likely to interfere with assessment of safety or how well it works of study treatment
- History of severe immediate hypersensitivity reaction to tocilizumab or any of the agents used in this study
- Treatment with a live, attenuated vaccine within 6 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study
- Women of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of chemotherapy on the fetus or infant.
- people of either sex who are not willing to practice birth control from the time of consent and at least 6 months after axicabtagene ciloleucel infusion
- In the investigators judgment, the subject is unlikely to complete all protocol- required study visits or procedures, including followup visits, or comply with the study requirements for participation.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
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 Toronto, Ontario, Canada. 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.