LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) Clinical Trial
Official title:
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+ CLL or SLL
| Verified date | May 2020 |
| Source | University of Pennsylvania |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Open-label pilot study to determine safety and efficacy of CART-19 cells in combination with ibrutinib. The target dose will be 1-5x10xE8 CART-19 transduced cells administered via split dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3. 15 evaluable subjects (adults) with relapsed or refractory CLL/SLL who have achieved partial response or stable disease on ibrutinib therapy will be eligible to receive CART-19 therapy.
| Status | Terminated |
| Enrollment | 20 |
| Est. completion date | July 16, 2019 |
| Est. primary completion date | October 15, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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) 3. Note: Patients carrying a deletion at chromosome 17p (i.e. del[17p]), and/or TP53, BTK, and at the PLC?2 loci mutations, will be eligible if they are receiving frontline therapy with ibrutinib. - 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. - Patients with relapsed disease after prior allogeneic SCT (myeloablative or nonmyeloablative) will be eligible if they meet all other inclusion criteria and: 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. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| University of Pennsylvania |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Adverse Events | 26 months |