Bone Marrow Transplant
|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
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.
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
- 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.
- Age greater than or equal to 18 years and less than or equal to 75 years
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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