Bone Marrow 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 |
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.
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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:
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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
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- 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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