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A Phase I Trial of Consolidation Therapy With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19 in Patients With Chronic Lymphocytic Leukemia Following Upfront Chemotherapy With Pentostatin, Cyclophosphamide and Rituximab


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

A Phase I Trial of Consolidation Therapy With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19 in Patients With Chronic Lymphocytic Leukemia Following Upfront Chemotherapy With Pentostatin, Cyclophosphamide and Rituximab


Inclusion Criteria:



- CLL patients with evidence of residual disease, who have achieved PR, nPR or CR with
detectable MRD following upfront therapy consisting of pentostatin, cyclophosphamide
and rituximab.

- The presence of MRD will be assessed by the flow cytometry and polymerasechain
reaction at the MSKCC Diagnostic Molecular Pathology Laboratory.

- Age ≥ 18 years of age.

- 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,
absolute neutrophil count ≥500/mm3, platelets ≥50,000/mm3, hemoglobin ≥8.0g/dl with
transfusion support.

- Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by
pulse oximetry.

Exclusion Criteria:

- Karnofsky performance status <70.

- Pregnant or lactating women. Women and men of childbearing age should use effective
contraception while on this study and continue for 1 year after all treatment is
finished.

- Impaired cardiac function (LVEF <40%) as assessed by ECHO or MUGA scan.

- Patients previously treated with allogeneic bone marrow or stem cell transplantation
are ineligible.

- Patients who are immediate candidates for allogeneic bone marrow or stem cell
transplantation. Patients who refuse this option remain eligible and need to be
documented as such in patient medical record.

- CLL patients with transformed disease (Richter's transformation) are ineligible for
enrollment on this study.

- Patients with HIV and active 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, with the exception of squamous and
basal cell carcinoma of skin.

STEP 2 REGISTRATION (Treatment):

The following additional criteria must be met in order for a patient to be eligible to
receive the modified T cell infusion. These labs are to be obtained within 2 weeks of T
cell infusion.

- 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,
absolute neutrophil count ≥500/mm3, platelets ≥50,000/mm3, hemoglobin ≥8.0g/dl with
transfusion support.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

toxicity

Outcome Description:

Criteria for toxicity: Toxicity will be graded on a scale of 1 to 5 as described by the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Jae Park, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

11-048

NCT ID:

NCT01416974

Start Date:

November 2011

Completion Date:

August 2014

Related Keywords:

  • Leukemia
  • 19-28Z RETROVIRUS
  • CYCLOPHOSPHAMIDE (CYTOXAN)
  • autologous T cells
  • Leukapheresis
  • 11-048
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021