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Complete title: Phase I/II Study of Immunotherapy for Advanced CD19+ Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma with Defined Subsets of Autologous T Cells Engineered to Express a CD19-Specific Chimeric Antigen Receptor
|Research Study Number||2639.00|
|Principal Investigator||David Maloney, MD, PhD|
Research Study Description
This phase I/II trial studies the side effects and best dose of laboratory treated T cells to see how well they work in treating patients with relapsed or refractory chronic lymphocytic leukemia, non-Hodgkin lymphoma, or acute lymphoblastic leukemia. T cells that are treated in the laboratory before being given back to the patient may make the body build an immune response to kill cancer cells.
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Patients with:
-- *Chronic lymphocytic leukemia (CLL) who are beyond first remission and who have failed combination chemoimmunotherapy with regimens containing a purine analogue and anti-CD20 antibody or who were not eligible for such therapy; patients with fludarabine refractory disease are eligible
-- *Indolent non-Hodgkin lymphoma (NHL) or mantle cell NHL who are beyond first remission and previously treated with chemoimmunotherapy or who were not eligible for such therapy; patients who have relapsed following autologous hematopoietic cell transplantation (HCT) are eligible
-- *Aggressive NHL such as diffuse large B-cell lymphoma (DLBCL) who have relapsed or have residual disease following treatment with curative intent; patients must have relapsed disease following high-dose therapy and autologous HCT or not be candidates for high-dose therapy; patients with CD19 expressing, relapsed acute lymphoblastic leukemia (ALL) without higher priority treatment options may be considered for inclusion in this cohort after discussion with the principal investigator (PI)
- Confirmation of diagnosis by internal pathology review of initial or subsequent biopsy or other pathologic material at the Fred Hutchinson Cancer Research Center (FHCRC)/Seattle Cancer Care Alliance (SCCA)
- Evidence of CD19 expression by immunohistochemistry or flow cytometry on any prior or current tumor specimen
- Karnofsky performance status >=70%
- Negative pregnancy test for women of childbearing potential
- All patients of childbearing potential must be willing to use a physician approved contraceptive method before, during, and for at least two months after the T cell infusion
- Ability to understand and provide informed consent
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Patients requiring corticosteroid therapy at a dose of > 15 mg of prednisone per day (or equivalent)
- Active autoimmune disease requiring immunosuppressive therapy
- Serum creatinine > 2.5 mg/dL
- Serum glutamic oxaloacetic transaminase (SGOT) > 5 x upper limit of normal
- Bilirubin > 3.0 mg/dL
- Forced expiratory volume in one second (FEV1) of < 2.0 L
- Diffusing capacity of the lung for carbon monoxide (DLCO) (corrected) < 40%
- Significant cardiovascular abnormalities as defined by any one of the following: congestive heart failure, clinically significant hypotension, symptomatic coronary artery disease, or a documented ejection fraction of < 35%
- Patients who are human immunodeficiency virus (HIV) seropositive
- Men or women of reproductive ability who are unwilling to use effective contraception or abstinence
- Uncontrolled active infection (bacterial, viral, fungal, mycobacterial) requiring treatment with intravenous antibiotics, antiviral or antifungal agents, or long-term treatment with oral agents
- Anticipated survival of < 3 months
Other exclusion criteria may apply.
Burkitt's Lymphoma; Hematologic Malignancies; Leukemia; Lymphoma
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