Clareo Health | Natalizumab for the Prevention of ICANS in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma Receiving CAR T-Cell Therapy
Natalizumab for the Prevention of ICANS in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma Receiving CAR T-Cell Therapy
Patient must be ≥ 18 years of age at the time of signing informed consent (ICF)
Patient must understand and voluntarily sign the ICF prior to conduct of any study-related assessments or procedures
Patient must be willing to adhere to the study visit schedule and other protocol requirements
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Patient must be eligible per institutional criteria for therapy with commercial axicabtagene ciloleucel or brexucabtagene autoleucel for treatment of relapsed or refractory diffuse large B-cell lymphoma or mantle cell lymphoma
Per institutional protocol: Females and males of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 12 months (female) or 4 months (males with female partners of reproductive potential) after the cyclophosphamide infusion. The two contraception methods can consist of two barrier methods or a barrier method plus a hormonal method. Female participants must agree to inform their male partners that they must use the methods of birth control required by the protocol. The use of intrauterine devices is excluded due to the risk of infection or bleeding
You may not be if
Uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate antibiotics or treatment
* Patients with infections controlled on antibiotics are not excluded
Prior history or current infection with John Cunningham (JC) virus
Active hepatitis B or C (latent hepatitis B will not be excluded), or HIV. Entecavir prophylaxis can be used for latent hepatitis B. Patients' viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing at screening
Bilirubin: ≥ 2.0 x upper limit of normal (ULN), unless attributed to Gilbert's Syndrome or to the patient's primary malignancy
Aspartate aminotransferase (AST): ≥ 5 x ULN, alanine aminotransferase (ALT): ≥ 5 x ULN
Active concurrent autoimmune disease requiring immunosuppressive therapy
Active central nervous system (CNS) lymphoma
Active clinically relevant central nervous system disease including but not limited to:
* Seizures/epilepsy
* Stroke within the past 12 months, or unstable neurologic deficits within the past 12 months
* Cerebral edema
* Aphasia
* Severe brain injury
* Cerebellar disease
* Documented history of dementia by clinical diagnosis
* Parkinson's disease
* Psychosis
Pregnant or nursing females
History of or active progressive multifocal leukoencephalopathy (PML)
Prior history or active herpes encephalitis or meningitis infection
Current treatment with any other agents for prophylaxis of CRS or ICANS, including investigational agents. Use of antiseizure medications does not exclude patients
History of prior exposure to natalizumab due to risk of neutralizing antibody formation
History of hypersensitivity reaction to natalizumab or the formulation excipients
Consider adding: History of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study
