Phase
Condition
Lymphoma
Treatment
Cyclophosphamide
Fludarabine
Rituximab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years old.
Able to understand and provide a signed informed consent that fulfills the relevantInstitutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
Histologically documented CD19- and CD20-positive B-cell NHL with the followingspecific criteria:
Have active disease after ≥ 2 lines of cytotoxic chemotherapy.
Have received rituximab or another anti-CD20 antibody.
Have either failed autologous transplant or are ineligible to receiveautologous transplant.
Have measurable disease by Lugano classification documented within 8 weeks ofthe time of consent, defined as nodal lesions > 15 mm in the long axis orextranodal lesions > 10 mm in long and short axis, or bone marrow involvementthat is biopsy proven.
Have CD19- and CD20-positive disease on most recent biopsy performed (a repeatbiopsy is not mandatory for this study except as noted below). A minimum of 5%CD19 and CD20 positivity by immunohistochemistry or flow cytometry on prior orrepeat biopsy is required.
History of central nervous system (CNS) involvement with cerebral spinal fluid (CSF)analysis following magnetic resonance imaging (MRI) brain and lumbar punctureshowing no evidence of CNS involvement by cytology and flow cytometry.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Expected survival > 12 weeks.
Willing and able to have central line placed for study drug infusions.
Stated willingness to comply with study procedures.
Able to attend required study visits and return for adequate follow-up, as requiredby this protocol.
Agreement to practice effective contraception for female subjects of child-bearingpotential and nonsterile males. Female subjects of child-bearing potential mustagree to use effective contraception while on study and for at least 5 months afterthe last dose of study drug. Nonsterile male subjects must agree to use a condomwhile on study and for up to 5 months after the last dose of study drug. Effectivecontraception includes surgical sterilization (eg, vasectomy, tubal ligation), twoforms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterinedevices (IUDs), and abstinence.
Exclusion
Exclusion Criteria:
Known hypersensitivity to any component of the study medication(s), includinganaphylactic reaction to sulfur-containing medications.
Known allergy to albumin (human) or dimethyl sulfoxide (DMSO).
Serious uncontrolled concomitant disease that would contraindicate the use of theinvestigational drug used in this study or that would put the subject at high riskfor treatment-related complications.
History of significant autoimmune disease OR active, uncontrolled autoimmunephenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis,autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroidtherapy defined as > 20 mg of prednisone or equivalent daily.
History of allogeneic hematopoietic stem-cell transplantation (HSCT) or allogeneicchimeric antigen receptor (CAR) T therapy within 6 months of day 1 or requireongoing systemic graft versus host disease (GvHD) therapy.
Anti-CD19 or anti-CD20 antibody treatment within 4 weeks of cell infusion.
Live vaccine < 6 weeks prior to starting lymphodepleting chemotherapy.
History of receiving allograft organ transplant requiring immunosuppression.
Subjects post solid organ transplant who develop high grade lymphomas or leukemias.
Known lymphomatous involvement of the CNS, including the parenchyma orleptomeninges.
Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerativedisease).
History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerativecolitis).
Inadequate organ function, evidenced by the following laboratory results:
ANC < 1000 cells/mm3.
Platelet count < 100,000 cells/mm3.
Total bilirubin ≥ 1.5 × the upper limit of normal (ULN; unless the subject hasdocumented Gilbert's syndrome or indirect hyperbilirubinemia).
Aspartate aminotransferase (AST [SGOT])/ALT (SGPT) ≥ 2.5 × ULN.
Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in subjects withbone metastases).
Serum creatinine > 1.6 mg/dL. Each study site should use its institutional ULNto determine eligibility.
Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) orclinically significant (ie, active) cardiovascular disease, cerebrovascularaccident/stroke, or myocardial infarction within 6 months prior to first studymedication; unstable angina; congestive heart failure of New York Heart Associationgrade 2 or higher; or serious cardiac arrhythmia requiring medication.
Current chronic daily treatment (continuous for > 3 months) with systemiccorticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone),excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergicreaction or anaphylaxis in subjects who have known contrast allergies is allowed.
Currently taking any medication(s) (herbal or prescribed) known to have an adversedrug reaction with any of the study medications.
History of human immunodeficiency virus (HIV) with current CD4+ T-cell count < 500cells/μL..
Chronic carriers of hepatitis B virus (HBV) infection that is currently hepatitis Bsurface antigen (HBsAg) positive. NOTE: Subjects who have a history of HIV/HBV orwho are seropositive will require testing for Infectious Disease Markers (IDM).
Concurrent active malignancy other than basal or squamous cell carcinomas of theskin.
Assessed by the Investigator to be unable or unwilling to comply with therequirements of the protocol.
Women who are pregnant or breastfeeding. A negative urine or serum pregnancy test inwomen of child bearing potential is required at screening and again within 48 hoursprior to lymphodepleting chemotherapy
Study Design
Study Description
Connect with a study center
CSSIFM
El Segundo, California 90245
United StatesSite Not Available
Hoag Memorial Hospital
Newport Beach, California 92663
United StatesSite Not Available
Hoag Memorial Hospital
Newport Beach 5376890, California 5332921 92663
United StatesActive - Recruiting
Texas Oncology
Tyler 4738214, Texas 4736286 75702
United StatesActive - Recruiting

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