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SCCA Lymphoma Clinical Trials

Immunotherapy for Advanced CD19+ Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma (2639)
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
Status Conditions Phase Study ID
Recruiting Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Acute Lymphoblastic Leukemia
Phase I/II 2639

This phase I/II trial studies the side effects and best dose of laboratory treated T cells and 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 may make the body build an immune response to kill cancer cells.

David Maloney, MD, PhD
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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; 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 due to inability to collect autologous peripheral blood stem cell (PBSC), advanced age or other co-morbid medical conditions; 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
  • Female 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
Exclusions (conditions that would prevent participation in this study)
  • Treatment with other investigational agent(s) within 30 days of enrollment
  • 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 or who have active hepatitis B or C
  • 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
Last Updated
June 10, 2013
See this trial at
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.