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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
NCT01865617
Summary

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.


Investigator
David Maloney, MD, PhD
Location    
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 ClinicalTrials.gov
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.