Pilot Trial Of Autologous T Cells Engineered To Express Anti-CD19 Chimeric Antigen Receptor (CART19)In Combination With Ibrutinib In Patients With Relapsed Or Refractory CD19+ Chronic Lymphocytic Leukemia (CLL)Or Small Lymphocytic Lymphoma (SLL)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Pennsylvania
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Documented CD19+ CLL or SLL
Successful test expansion -cells (as described in Section 6.1)
Patients must have failed at least 1 prior regimen before Ibrutinib (not including single agent rituximab or single agent corticosteroids)
a. Note: Any relapse after prior autologous SCT will make the patient eligible regardless of other prior therapy.
Patients must be currently receiving ibrutinib for at least 6 months prior to enrollment in the study and:
1. Not experiencing any ≥ grade 2 non-hematologic ibrutinib-related toxicity
2. The best response to ibrutinib therapy must not have exceeded partial response or stable disease (i.e. no CR or CRi)
ECOG Performance status 0 or 1
18 years of age and older
Adequate organ system function including:
1. Creatinine \< 1.6 mg/dl
2. ALT/AST \< 3x upper limit of normal
3. Total Bilirubin \<2.0 mg/dl with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is ≥ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN.
1. Have no active GVHD and require no immunosuppression
2. Are more than 6 months from transplant
No contraindications for leukapheresis
Left Ventricular Ejection fraction \>40%
Gives voluntary informed consent
Subjects of reproductive potential must agree to use acceptable birth control methods.
You may not be if
CLL patients with known or suspected transformed disease (i.e. Richter's transformation). Note: biopsy proven absence of transformation is not required.
Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
Uncontrolled active infection.
Active hepatitis B or hepatitis C infection.
Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary.
Any uncontrolled active medical disorder that would preclude participation as outlined.
HIV infection.
Patients with active CNS involvement with malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was \>4 weeks before enrollment.
Class III/IV cardiovascular disability according to the New York Heart Association Classification.
Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment.
Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.
Clareo Health | Pilot Trial Of Autologous T Cells Engineered To Express Anti-CD19 Chimeric Antigen Receptor (CART19)In Combination With Ibrutinib In Patients With Relapsed Or Refractory CD19+ Chronic Lymphocytic Leukemia (CLL)Or Small Lymphocytic Lymphoma (SLL)
