2024-510972-19-00
Recruiting
Phase 2
Axicabtagene Ciloleucel CAR T-Cells in Patients with relapsed or refractory primary mediastinal B-Cell Lymphoma
Universitaet Muenster23 sites in 1 country40 target enrollmentStarted: February 7, 2025Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Universitaet Muenster
- Enrollment
- 40
- Locations
- 23
- Primary Endpoint
- CMR rate at 3 months from axicabtagene ciloleucel infusion based on disease assessment by PET-CT or PET-MRI according to Deauville and Lugano Classification
Overview
Brief Summary
Evaluate the efficacy of axicabtagene ciloleucel in subjects with r/r PMBCL as measured by complete metabolic response (CMR) rate
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1.Signed written informed consent form (ICF)
- •Age > 18 years
- •ECOG performance status < 2
- •Histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) • based on the 2022 World Health Organization (WHO) (R. Allagio et al.) • classification by local pathology laboratory assessment
- •Patients must have received adequate first-line therapy including: • An anti-CD20 monoclonal antibody (rituximab), and • CHOP or CHOP-like chemotherapy Note: CHOP-like chemotherapy corresponds to CHOEP, ACVBP or EPOCH or COPADEM. Patients who received dose-reduced CHOP (e.g., mini-CHOP) are excluded except for dose reductions of vincristine due to peripheral neuropathy. Patients who have received additional drugs in combination with CHOP or CHOP-like regimen are eligible.
- •Relapsed or refractory disease after first-line chemoimmunotherapy, documented by PET-CT: • Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse • 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) and biopsy-proven residual disease, or Partial response (PR) as best response after at least 6 cycles, and biopsy-proven residual disease
- •At least 2 weeks must have elapsed since any prior systemic cancer therapy at the time the patient provides consent
- •Lymphoma tissue at recurrence available for central pathologic examination, exploratory endpoints, and ancillary studies (detailed sample collection requirements are described in protocol section 8.2)
- •Patients must have at least 1 measurable lesion per the Lugano Classification on anatomical imaging such as computed tomography (CT) imaging (functional imaging such as PET may not be used to identify a measurable lesion). A measurable lesion is defined as greater than 1.5 cm LDi for lymph node and greater than 1.0 cm LDi for extranodal lesions
- •Patients must be eligible for CAR T-cells as defined by: • Patient deemed eligible for CAR T-cells therapy by the study physician • Adequate vascular access for leukapheresis procedure (either peripheral or central venous line)
Exclusion Criteria
- •Patients who received more than one prior line of systemic therapy
- •Prior CD19-targeted therapy
- •History of another primary malignancy that has not been in remission for at least 2 years (except for non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast)). A maintenance treatment is not allowed
- •History or presence of non-malignant CNS disorder, such as seizure disorder requiring anti-convulsive therapy, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome (PRES), or cerebral edema with confirmed structural defects by appropriate imaging. History of stroke or transient ischemic attack within 12 months prior to enrollment. • Secondary CNS involvement of PMBCL is not an exclusion criterion
- •History of acute or chronic active hepatitis B or C infection. If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing
- •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/µl
- •Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal catheter). Dedicated venous access catheters, such as a Port-a-Cath or Hickman catheter, are permitted
- •Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antimicrobials at the time of enrollment
- •Presence of cardiac atrial or ventricular lymphoma involvement
- •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 infarction, unstable angina, or other clinically significant cardiac disease
Outcomes
Primary Outcomes
CMR rate at 3 months from axicabtagene ciloleucel infusion based on disease assessment by PET-CT or PET-MRI according to Deauville and Lugano Classification
CMR rate at 3 months from axicabtagene ciloleucel infusion based on disease assessment by PET-CT or PET-MRI according to Deauville and Lugano Classification
Secondary Outcomes
No secondary outcomes reported
Investigators
Georg Lenz
Scientific
Universitaet Muenster
Study Sites (23)
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