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Tests treatment safety and results for DIFFUSE LARGE B-CELL LYMPHOMA
Official title Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma
ClinicalTrials.gov ID: NCT07254754
What this study is testing
What is Axicabtagene Ciloleucel?
Axicabtagene Ciloleucel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diffuse large b-cell lymphoma.
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
- Single-arm, open-label, multicenter, phase II trial aiming to include approximately 45 patients over 24 months. Patients will receive axicabtagene ciloleucel infusion and will be followed up to 5 years.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
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
- Signed written Informed Consent Form
- Age \> 18 years
- Patient who understands and speaks one of the country official languages
- Histologically proven relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL) of the following histology at relapse: diffuse large...
- Positron-emission tomography (PET)-positive disease
You likely can't join if
- Patients who received more than one prior line of systemic therapy
- Early relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease relapse before 12 months from end of...
- Refractory disease defined as:
- Progressive disease (PD) during first-line therapy
- Stable disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP)
- Partial response (PR) as best response after at least 6 cycles, and biopsy-proven residual disease
See the full eligibility criteria
Who can join
- Signed written Informed Consent Form
- Age \> 18 years
- Patient who understands and speaks one of the country official languages
- Histologically proven relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL) of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL) and follicular...
- Positron-emission tomography (PET)-positive disease
- Patients must have received adequate first-line therapy including at a minimum:
- An anti-CD20 monoclonal antibody (rituximab or obinutuzumab), and
- CHOP or CHOP-like chemotherapy Note: CHOP-like chemotherapy corresponds to ACVBP, EPOCH, or COPADEM. Dose-reduced CHOP (i.e., miniCHOP) is excluded except for dose-reductions of vincristine due to peripheral neuropathy...
- Relapsed disease after first line chemo immunotherapy (full dose of R-CHOP or R-CHOP-like regimen), documented by PET-scan and biopsy:
- Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease relapse after 12 months and up to 5 years from end of first-line therapy.
- Patients must meet CAR-T-eligible criteria as defined by:
- Patient deemed eligible for CAR T-cells therapy by the CAR-T physician
- AND all the following criteria:
- ECOG performance status of 0, 1 or 2
- Adequate vascular access for leukapheresis procedure (either peripheral or central venous line)
- Absolute neutrophil count (ANC) ≥ 1 x 109/L
- Platelets ≥ 75 x 109/L
- Absolute lymphocyte count ≥ 0.1 x 109/L
- Creatinine clearance (CrCl) as estimated by Cockcroft Gault or MDRD ≥ 40 mL/min
- Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5xULN
- Total bilirubin \<1.5 mg/dL, except in patients with Gilbert's syndrome
- Cardiac ejection fraction ≥ 45%
- Baseline oxygen saturation ≥ 92% on room air
- 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 12 months are not considered to be of...
What rules you out
- Patients who received more than one prior line of systemic therapy
- Early relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease relapse before 12 months from end of first-line therapy.
- Refractory disease defined as:
- Progressive disease (PD) during first-line therapy
- Stable disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP)
- Partial response (PR) as best response after at least 6 cycles, and biopsy-proven residual disease
- Patients who received first line of R-CHOP or obinutuzumab-CHOP for an indolent B-NHL who relapse as transformed aggressive B-NHL after a year from the end of first-line therapy are NOT eligible.
- Prior CD19 targeted therapy
- Patients with cardiac atrial or cardiac ventricular lymphoma involvement
- Requirement for urgent therapy due to tumor mass effects, such as bowel obstruction or blood vessel compression
- Patient with clinically significant pleural effusion
- History of another primary malignancy that has not been in remission for at least 3 years (except for nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast)). A maintenance treatment is not allowed.
- Patients with detectable Central Nervous System (CNS) lymphoma. Patients with a history of CNS lymphoma but no active CNS disease (after systematic MRI and lumbar puncture) at the time of enrolment will be eligible.
- Presence of CNS disorder such as dementia, autoimmune disease with CNS involvement, cerebral edema with confirmed structural defects by appropriate imaging, or seizure disorders requiring active anticonvulsive...
- Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access...
- History of acute or chronic active hepatitis B or C infection (seropositivity). If there is a positive history of treated hepatitis B or hepatitis C (negative HBsAg and positive Anti-HBc/ positive anti-HCV), the viral...
- Positive for human immunodeficiency virus (HIV) unless taking appropriate anti-HIV medications, with an undetectable viral load by PCR and with a CD4 count \> 200 cells/uL.
- Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antimicrobials or other treatment at the time of leukapheresis or axicabtagene ciloleucel administration
- History of any one of the following cardiovascular conditions within the past 12 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial...
- Presence of primary immunodeficiency
- History of any medical condition including but not limited to autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression and/or systemic disease modifying...
- 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 severe immediate hypersensitivity reaction to tocilizumab or any of the agents used in this study
- History of severe, immediate hypersensitivity reaction attributed to aminoglycosides, cyclophosphamide or fludarabine
- 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 study
- Women of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of lymphodepletion chemotherapy on the fetus or infant.
- Patients of either sex who are not willing to practice birth control from the time of consent during treatment and for at least 12 months after conditioning chemotherapy dosing or axicabtagene ciloleucel dosing...
- In the investigator's judgment, the patient is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
- Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness.
The study team makes the final eligibility decision.
Where it's taking place
- A Coruña, A Coruña, Spain
- Palma de Mallorca, Balearic Islands, Spain
- Santander, Cantabria, Spain
- Salamanca, Castille and León, Spain
- Barcelona, Catalonia, Spain
- L'Hospitalet de Llobregat, Catalonia, Spain
- San Sebastián, Gipuzkoa, Spain
- Las Palmas de Gran Canaria, Las Palmas, Spain
- Madrid, Madrid, Spain
- Murcia, Murcia, Spain
- Pamplona, Navarre, Spain
- Seville, Sevilla, Spain
- Valencia, Valencia, Spain
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 study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 A Coruña, A Coruña, Spain; Palma de Mallorca, Balearic Islands, Spain; Santander, Cantabria, Spain; Salamanca, Castille and León, Spain; Barcelona, Catalonia, Spain; L'Hospitalet de Llobregat, Catalonia, Spain and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.