T Cells Plus Selected Use of Blinatumomab

Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation

What's the purpose of the trial?

This study seeks to examine treatment therapy that will reduced regimen-related toxicity and relapse while promoting rapid immune reconstitution with limited serious graft-versus-host-disease (GVHD) and also improve disease-free survival and quality of life. The investigators propose to evaluate the safety and efficacy of selective naive T-cell depleted (by TCRɑβ and CD45RA depletion, respectively) haploidentical hematopoietic cell transplant (HCT) following reduced intensity conditioning regimen that avoids radiation in patients with hematologic malignancies that have relapsed or are refractory following prior allogeneic transplantation. PRIMARY OBJECTIVE: * To estimate engraftment by day +30 post-transplant in patients who receive TCRɑβ-depleted and CD45RA-depleted haploidentical donor progenitor cell transplantation following reduced intensity conditioning regimen without radiation. SECONDARY OBJECTIVES: * Assess the safety and feasibility of the addition of Blinatumomab in the early post-engraftment period in patients with CD19+ malignancy. * Estimate the incidence of malignant relapse, event-free survival, and overall survival at one-year post-transplantation. * Estimate incidence and severity of acute and chronic (GVHD). * Estimate the rate of transplant related mortality (TRM) in the first 100 days after transplantation.
Trial status

Accepting patients

Phase
Phase 2
Enrollment
52
Last Updated
2 weeks ago
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Participating Centers

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Experimental Treatments

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  • Allogeneic Stem Cell Transplant is a type of stem cell transplant that utilizes a donor's pre-collected stem cells to rescue the bone marrow from the toxic effects of very high dose chemotherapy.
  • Antithymocyte Globulin (ATG) is an antibody preparation made from rabbits or horses immune cells altered with human thymocytes. ATG is used to prevent or treat acute cellular rejection after solid organ transplantation and as a therapy for certain other blood disorders.
  • Blinatumomab is an anti-CD19/anti-CD3 bi-specific T cell engager that is approved to treat acute lymphoblastic leukemia and being studied for use in other indications. 
  • Cyclophosphamide is a chemotherapy agent used in the treatment of cancer.
  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Granulocyte Colony-Stimulating Factor is a glycoprotein used to stimulate the bone marrow to help with granulocyte and stem cell production.
  • Melphalan is a chemotherapy medication used in the treatment of different cancers.
  • Mesna is a cytoprotectant drug used to reduce the risk of bleeding from the bladder in patients receiving certain types of chemotherapy.
  • Rituximab is an anti-CD20 monoclonal antibody currently approved for use in B-Cell Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukemia, and several autoimmune conditions.
  • Sirolimus is an immunosuppressive medication used in several indications, including to help prevent rejection in patients who have had a transplant.
  • Tacrolimus is an immunosuppressive medication used to help prevent rejection in patients who have had a transplant.
  • Thiotepa is an antineoplastic chemotherapy agent that is used to treat several different kinds of cancer.

Arms / Cohorts

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Accepting patients

Treatment

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