Genetically Engineered Lymphocyte Therapy in Treating Patients With B-Cell Leukemia or Lymphoma That is Resistant or Refractory to Chemotherapy

Description

RATIONALE: Placing a gene that has been created in the laboratory into white blood cells may make the body build an immune response to kill cancer cells. PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with B-cell leukemia or lymphoma that is resistant or refractory to chemotherapy.

Study Start Date

July 2009

Estimated Completion Date

October 2016

Interventions

  • Genetic: reverse transcriptase-polymerase chain reaction
  • Genetic: polymerase chain reaction
  • Other: laboratory biomarker analysis
  • Biological: anti-CD19-CAR retroviral vector-transduced autologous T cells
  • Biological: genetically engineered lymphocyte therapy

Specialties

  • Internal Medicine: Basic Science/Genetics,Hematology/Oncology
  • Nursing: Hematology/Oncology
  • Oncology: Basic Science/Genetics,Leukemia/Lymphoma,Pharmacology/Therapy
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Study ID

Abramson Cancer Center of the University of Pennsylvania -- UPCC 04409

Status

Unknown

Trial ID

NCT01029366

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

110

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Inclusion
  • Male and female subjects with CD19+ B cell malignancies in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled
  • CD19+ leukemia or lymphoma
  • ALL in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor
  • Follicular lymphoma, previously identified as CD19+:
  • At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituxan) therapy
  • Stage III-IV disease
  • Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval < 1 year)
  • Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc)
  • CLL:
  • At least 2 prior chemotherapy regimens (not including single agent monoclonal antibody (Rituxan) therapy
  • Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval < 1 year)
  • Not eligible or appropriate for conventional allogeneic SCT
  • Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc)
  • Mantle cell lymphoma:
  • Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous SCT
  • Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc...)
  • Relapsed after prior autologous SCT
  • B-cell prolymphocytic leukemia (PLL) with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT
  • Diffuse large cell lymphoma, previously identified as CD19+:
  • Residual disease after primary therapy and not eligible for autologous SCT
  • Relapsed after prior autologous SCT
  • Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate of conventional allogeneic or autologous SCT
  • Expected survival > 12 weeks
  • Creatinine < 2.5 mg/dl
  • ALT/AST < 3x normal
  • Bilirubin < 2.0 mg/dl
  • Any relapse after prior autologous SCT will make patient eligible regardless of other prior therapy
  • Adequate venous access for apheresis, and no other contraindications for leukapheresis
  • Voluntary informed consent is given Exclusion
  • Pregnant or lactating women
  • The safety of this therapy on unborn children is not known
  • Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
  • Uncontrolled active infection
  • Active hepatitis B or hepatitis C infection
  • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
  • Previously treatment with any gene therapy products
  • Feasibility assessment during screening demonstrates < 30% transduction of target lymphocytes, or insufficient expansion (< 5-fold) in response to CD3/CD28 costimulation
  • Any uncontrolled active medical disorder that would preclude participation as outlined
  • HIV infection
  • Gender

    Both

    Ages

    18 Years and older

    Accepts Healthy Volunteers

    No

    Study Locations and Contact Information (1)

    Study Location Distance Name Phone Email
    Abramson Cancer Center of The University of Pennsylvania - Philadelphia, Pennsylvania 128.2 miles Holly McConville RN 855-216-0098 PennCancerTrials@emergingmed.com

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