Study on Using Genetically Modified T Cells to Treat Relapsed or Resistant Chronic Lymphocytic Leukemia or Indolent B Cell Lymphoma
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT00466531
This clinical trial is testing a new treatment that uses a patient's own T cells, which are modified in the lab to target and kill cancer cells. The study aims to determine if this approach is safe and effective for patients with certain types of leukemia and lymphoma that have not responded to previous treatments.
Patient Parameters
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Program Overview
The purpose of this study is to see if using a patient's own T cells, which are genetically modified in the lab to target a specific protein on cancer cells, can help the body fight cancer more effectively. These modified T cells are combined with a chemotherapy drug called cyclophosphamide to see if they can kill more cancer cells together. The study is conducted in two stages: the first stage focuses on safety, and the second stage looks at how well the treatment works.
Description
This study is divided into two phases. In Phase I, the main goal is to ensure the safety of using genetically modified T cells that target a protein called CD19 on cancer cells. These T cells are called CAR T cells. Some patients will receive these T cells alone, while others will receive them after a dose of chemotherapy to prepare their body. The study will start with a low dose of T cells and gradually increase the dose to find the safest and most effective amount.
In Phase IIa, the study will compare two types of CAR T cells that have different ways of signaling the immune system to attack cancer cells. The researchers want to see which type of CAR T cell stays in the body longer and works better against cancer. They will also compare how well the T cells are modified using two different methods.
Participants will receive the modified T cells in a hospital setting, and their health will be closely monitored to check for any side effects and to see how well the treatment is working. The study aims to find out if this new approach can help patients with chronic lymphocytic leukemia or indolent B cell lymphoma that has returned or not responded to standard treatments.
Eligibility Criteria
Inclusion:
• Patients must have the following CD19+ B cell leukemia or lymphoma either with relapsed or chemotherapy-refractory disease or with evidence of residual disease following therapy.
In all cases, patient's disease must be confirmed at MSKCC.
- CLL: Patients must have a diagnosis of CLL as evidenced by flow cytometry, bone marrow histology, and/or cytogenetics.
- Other low grade B-cell neoplasms are eligible for study, such as small lymphocytic lymphoma (SLL), follicular lymphoma, Waldenstrom's macroglobulinemia, hairy cell leukemia, marginal zone lymphomas, and mantle cell lymphomas.
- Creatinine ≤2.0 mg/100 ml, bilirubin ≤2.0 mg/100 ml, AST and ALT ≤3.0x normal, PT and PTT ≤ 2x normal outside the setting of stable chronic anticoagulation therapy, granulocytes ≥1,000/mm3, platelets ≥50,000/mm3, hemoglobin ≥8.0g/dl with transfusion support
- Adequate cardiac function (LVEF ≥40%) as assessed by ECHO or MUGA scan performed within 1 month of treatment.
- Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry.
- Life expectancy of > 3 months.
Exclusion:
- Karnofsky performance status <70.
- CLL patients with active transformed disease (Richter's transformation) are ineligible for enrollment on this study.
- Patients with following cardiac conditions will be excluded:
- New York Heart Association (NYHA) stage III or IV congestive heart failure
- Myocardial infarction ≤6 months prior to enrollment
- History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
- History of severe non-ischemic cardiomyopathy with EF ≤20%
- Patients with HIV, hepatitis B or hepatitis C infection are ineligible.
- Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
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