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

Sponsored by Abramson Cancer Center of the University of Pennsylvania

Phase Quota
Phase N/A

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

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

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

Inclusion criteria

  • 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 criteria

  • 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

Study Locations And Contact Information

  • Abramson Cancer Center of The University of Pennsylvania, Philadelphia Pennsylvania
    Contact: Holly McConville RN 855-216-0098 PennCancerTrials@emergingmed.com

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