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Protocol No. UW14113

Principal Investigator Kenkre, Vaishalee

Phase Pilot/Feasibility

Age Group Adult

Scope Local

Sponsor Type Institutional

Title A pilot study to assess engraftment using CliniMACS TCR-alpha/beta and CD19 depleted stem cell grafts from haploidentical donors for hematopoietic progenitor cell transplantation in patients with relapsed lymphoma

Objective This study is being done to assess an investigational treatment regimen. Using a partially matched stem cell donor might have the benefit of the donor cells being more active against your cancer ("graft versus lymphoma", GVL), but also those cells being more active against your body ("graft versus host disease", GVHD). We are studying the process of removing the cells that are thought to be most important in GVHD ("α/β T cells" - particular T cell, an immune system cell) prior to giving you the remainder of the donor stem cells. We are studying whether this process is safe enough to allow further testing of this approach in more detailed clinical trials.

Treatment We are assessing a conditioning regimen (chemotherapy and radiation) in combination with an investigationally manipulated stem cell product to determine whether the combination will lead to a successful transplant and achieve lower rates of Graft versus Host Disease (GVHD) in subjects with relapsed lymphoma.

Description In order to suppress your own bone marrow enough to accept the donor stem cells, we will administer chemotherapy and radiation. The main intent is to suppress your bone marrow, but these treatments are typically active against lymphoma, too. On Day 0 (the day of the transplant), your donor's peripheral blood stem cells will be given to you through your catheter. Depending on the number of "α/β T cells" in the product you receive, you will receive at least 1, if not 2, medications for immunosuppression. You will receive mycophenolate mofetil (also called Cellcept®), and might receive tacrolimus (also called FK-506 or Prograf®) if the "α/β T cell" content is high. You will continue to take mycophenolate mofetil for about 30 days and if you are on tacrolimus, might take it for up to 6 months. These two medications are commonly used for the prevention of GVHD. In standard transplants, we routinely use two agents to prevent GVHD. Because in this study, we are removing many of the "α/β T cells", the need for a second agent is not thought to be necessary, unless we are not able to remove what is considered "enough" of these cells. If there is an increased number of B cells (another immune system cell) in the product you receive, you might additionally require rituximab. This is an anti-lymphoma treatment, but can also be helpful at fighting the harmful effects of increased B cells, that can include GVHD and post-transplant lymphoproliferative disorder (a separate lymphoma caused by altering the immune system). Rituximab would be administered as a single infusion on Day +2. For this study, additional tests will be performed on your blood samples to determine the specific T cell populations that exist in your blood following transplant. You will be monitored closely for any signs and symptoms of GVHD.

Key Eligibility
  • Age 18 to 75
  • Relapsed/refractory Hodgkin lymphoma after ASCT within previous 24 months
  • Relapsed/refractory Hodgkin lymphoma, deemed ineligible for ASCT due to refractory disease within previous 24 months
  • Relapsed/refractory diffuse large B cell lymphoma after ASCT (history of transformed lymphoma is acceptable) within previous 24 months
  • Relapsed/refractory diffuse large B cell lymphoma, deemed ineligible for ASCT due to refractory disease (history of transformed lymphoma is acceptable) within previous 24 months
  • Relapsed/refractory T cell lymphoma relapsed after at least 1 prior line of therapy within previous 24 months
  • Relapsed/refractory follicular lymphoma relapsed after at least 1 prior line of therapy within previous 24 months
  • Relapsed/refractory mantle cell lymphoma relapsed after at least 1 prior line of therapy within previous 24 months
  • Relapsed/refractory small lymphocytic lymphoma/chronic lymphocytic leukemia relapsed after at least 1 prior line of therapy within previous 24 months
  • Relapsed/refractory non-Hodgkin Lymphoma, if not specified above, relapsed after at least 1 prior line of therapy within previous 24 months
  • Patients with active CNS lymphoma within two weeks of registration will be excluded
  • Patients with the presence of HIV (Ab positivity), or active hepatitis A, B or C infection will be excluded
  • For an indolent lymphoma histology (follicular lymphoma, SLL/CLL) or mantle cell lymphoma, the patient should not have an HLA-matched sibling, who would be an eligible donor, available
  • Vulnerable population groups, i.e., prisoners, those lacking consent capacity, non-English speaking, illiterate, pregnant females will be excluded

Applicable Disease Sites Bone Marrow Transplant; Hematologic cancers, other; Leukemia; Lymphoma

Therapies Involved Bone Marrow Transplant; Cytotoxic Chemotherapy; Radiotherapy

Drugs Involved CellCept (Mycophenolate mofetil); Mycophenolate mofetil; Prograf (tacrolimus); chimeric anti-CD20 monoclonal antibody (rituximab); cpm (cyclophosphamide); ctx (cyclophosphamide); cyclophosphamide; cytoxan (cyclophosphamide); f-ara-amp (fludarabine); flamp (fludarabine); fludara (fludarabine); fludarabine; idec-c2B8 (rituximab); neosar (cyclophosphamide); rituxan (rituximab); rituximab; tacrolimus

Status Open

Participating Institutions UW Hospital and Clinics