Status:
ACTIVE_NOT_RECRUITING
Treatment of Relapsed or Chemotherapy Refractory Chronic Lymphocytic Leukemia or Indolent B Cell Lymphoma Using Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Using T cells from the patient that have been treated in the laboratory may help the body build an effective immune response to kill cancer cells. Drugs used in chemotherapy, such as cyclop...
Detailed Description
OBJECTIVES: Phase 1: The primary objective is to assess the safety of autologous T cells genetically modified to express chimeric antigen receptor (CAR) targeting CD19 antigen (19-28z) with or withou...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 21 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00466531
Start Date
March 21 2007
End Date
December 1 2026
Last Update
April 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065