A Phase I Trial of Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19
- Adult patients are eligible (> or = to 18 year old).
- Patients must have ALL refractory, relapsed, MRD, or in first CR as described below.
- Complete remission is defined as restoration of normal hematopoiesis with a
neutrophil count > 1,000 x 106/L, a platelet count > 100,000 x 106/L, and hemoglobin
> 10 g/dL. Blasts should be < 5% in a post-treatment bone marrow differential.
Furthermore, there should be no clinical evidence of leukemia for a minimum of four
- MRD is defined as patients meeting the criteria for CR above, but with residual
disease measured by a quantitative PCR, done by the Molecular Pathology Facility at
MSKCC. or by flow cytometry performed by the Cell Marker Laboratory at MSKCC, or by
deep-sequencing of the IgH rearrangements done by an accredited outside facility. The
assay from blood and/or bone marrow defines MRD by qPCR as a cycle threshold (CT)
that is at least 1 CT value < than the lowest CT value from the background. Outside
laboratory tests may suffice for this assessment at the discretion of the Principal
Relapsed B-ALL will be defined as patients that meet the above criteria for a CR before
developing recurrent disease (increased bone marrow blasts). Refractory patients will be
defined as patients that have not achieved a CR after 2 cycles of induction chemotherapy
- Patients must have a diagnosis of B-ALL by flow cytometry, or bone marrow histology,
and/or cytogenetics. These studies are to be performed at Memorial Hospital.
- Patients must have CD19+ ALL as confirmed by flow cytometry.
- Creatinine < 2.0 mg/100 ml, bilirubin < 2.0 mg/100 ml, AST and ALT < 3x normal, PT
and PTT < 2x normal outside the setting of stable chronic anticoagulation therapy.
- Adequate cardiac function (LVEF > 40%) as assessed by ECHO or MUGA performed within 1
month of enrollment.
- Adequate pulmonary function as assessed by > 92% oxygen saturation on room air by
- Patients must have adequate access for leukapheresis procedure as assessed by staff
from the MSKCC Donor Room.
- Life expectancy > 3 months
- Karnofsky performance status < 70.
- Patients previously treated with an allogeneic SCT that is currently complicated by
active GVHD requiring T cell suppressive therapy.
- Patients with HIV, hepatitis B or hepatitis C infection.
- Patients with any concurrent active malignancies as defined by malignancies requiring
any therapy other than expectant observation.