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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

Phase 1
18 Years
Open (Enrolling)
Leukemia, Acute Lymphoblastic Leukemia

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Trial Information

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

Inclusion Criteria:

- 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
pulse oximetry.

- Patients must have adequate access for leukapheresis procedure as assessed by staff
from the MSKCC Donor Room.

- Life expectancy > 3 months

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in adult patients with B-ALL.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Marco Davila, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2010

Completion Date:

January 2014

Related Keywords:

  • Leukemia
  • Acute Lymphoblastic Leukemia
  • Cyclophosphamide
  • T cell
  • leukapheresis
  • stem cell transplant
  • bone marrow transplant
  • 09-114
  • Burkitt Lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma



Memorial Sloan Kettering Cancer CenterNew York, New York  10021