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Bone Marrow Transplant

CD19-specific Donor T Cells for B Cell Malignancies After Allogeneic Transplant (FH 2494)
A Phase I/II Study of Cellular Immunotherapy With Donor Central Memory-derived Virus-specific CD8+ T-cells Engineered to Target CD19 for CD19+ Malignancies at High Risk of Relapse After Allogeneic Hematopoietic Stem Cell Transplant
Status Conditions Phase Study ID
Recruiting Recurrent Adult Acute Lymphoblastic Leukemia;
Recurrent Adult Diffuse Large Cell Lymphoma;
Recurrent Grade 1 Follicular Lymphoma;
Recurrent Grade 2 Follicular Lymphoma;
Recurrent Mantle Cell Lymphoma;
Recurrent Marginal Zone Lymphoma;
Recurrent Small Lymphocytic Lymphoma;
Refractory Chronic Lymphocytic Leukemia
Phase I/II FH 2494
NCT01475058
Summary

This phase I/II trial studies the safety and toxicity of post-transplant treatment with donor T cells engineered to target CD19 in patients who have had a matched related allogeneic hematopoietic stem cell transplant for a CD19+ B cell malignancy and are at high-risk of disease relapse after transplant.


Investigator
Cameron J. Turtle, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  1. Patients with CD19+ B cell malignancy who are planned for peripheral blood stem cell transplant from an HLA-matched related donor after myeloablative or non-myeloablative conditioning on a Fred Hutchinson Cancer Research Center (FHCRC) transplant protocol and are at high risk of relapse after HCT defined by any one of the disease-specific criteria listed below:

    • Philadelphia chromosome negative acute lymphoblastic leukemia:?

      • Beyond first complete remission (CR) at the time of pre-transplant evaluation
      • First morphologic CR but with evidence of minimal residual disease by flow cytometry, conventional cytogenetics, fluorescence in situ hybridization (FISH) or polymerase chain reaction (PCR) prior to transplant
      • First CR with poor risk cytogenetics (t(4:11), t(8;14), hypodiploidy, near triploidy or > 5 cytogenetic abnormalities) at diagnosis
    • Chronic lymphocytic leukemia, or low grade B cell lymphoma:?Lymph nodes greater than or equal to 5 cm at the time of pre-transplant evaluation
    • Mantle cell lymphoma:?Lymph nodes greater than or equal to 2 cm at the time of pre-transplant evaluation
    • Diffuse large B cell lymphoma, large B cell transformation of an indolent lymphoma or other large B cell lymphoma:?Not in CR by conventional computed tomography (CT) criteria or in CR by conventional criteria but with evidence of residual disease by a positive positron emission tomography (PET) scan
  2. Confirmation of tumor diagnosis and expression of CD19 after review by University of Washington Medical Center (UWMC) or Seattle Cancer Care Alliance (SCCA) pathology services.
  3. Age greater than or equal to 18 years and less than or equal to 75 years
Exclusions (conditions that would prevent participation in this study)
  • Philadelphia chromosome positive acute lymphocytic leukemia
  • Central nervous system (CNS) tumor refractory to intrathecal chemotherapy and/or cranio-spinal radiation
  • Human immunodeficiency virus (HIV) seropositive
  • Significant medical or psychological conditions that would make them unsuitable candidates for allogeneic HCT and T cell therapy
  • Fertile patients unwilling to use contraception during and for 12 months after HCT
  • Pregnant or breast-feeding
Last Updated
November 07, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.