Your journey
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2Find
3Review
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More info
You can access this
clinical trial
if you have
Leukemia or Lymphoma
and you are
under 21
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
Show me locations

The purpose

In this study, participants with high-risk hematologic malignancies undergoing hematopoietic cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA) matched related/sibling donor (MSD) or matched unrelated donor (MUD) identified, will receive a haploidentical donor HCT with additional natural killer (NK) cells. The investigators anticipate enrollment of 75 donors and 75 recipients. PRIMARY OBJECTIVE: - To estimate the rate of successful engraftment at day +42 post-transplant in patients who receive haploidentical donor stem cell plus NK cell transplantation with TLI based conditioning regimen for high risk hematologic malignancy. SECONDARY OBJECTIVES: - 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.

Provided treatments

  • Radiation: Total Lymphoid Irradiation
  • Drug: Fludarabine
  • Drug: Cyclophosphamide
  • Drug: Thiotepa
  • Drug: Melphalan
  • Biological: HPC,A Infusion
  • Biological: TC-NK Infusion
  • Biological: G-CSF
  • Drug: Mesna
  • Device: CliniMACS
  • Drug: Mycophenolate mofetil
Wondering what is the locations section for?
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Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01807611. The sponsor of the trial is St. Jude Children's Research Hospital and it is looking for 150 volunteers for the current phase.
Official trial title:
Haploidentical Donor Hematopoietic Progenitor Cell and Natural Killer Cell Transplantation With a TLI Based Conditioning Regimen in Patients With Hematologic Malignancies