Chemoimmunotherapy Followed by Reduced Toxicity Stem Cell Transplant in Children, Adolescents, and Young Adults With Advanced NK or Peripheral T-Cell LymphomaLeukemia

What this Trial Is About

Researchers are evaluating the use of chemoimmunotherapy followed by allogeneic stem cell transplant in children, adolescents, and young adults with advanced stage mature non-anaplastic T-cell or NK lymphomaleukemia. The study includes two groups based on diagnosis one with advanced NK cell leukemia or nasal type lymphoma, and the other with advanced peripheral T-cell lymphoma. This early phase 1 trial aims to assess overall response rates at one year and event-free survival over two years. Patients in Cohort 1 receive a modified SMILE chemotherapy regimen including methotrexate, ifosfamide, dexamethasone, etoposide, and pegaspargase, with pembrolizumab added for those not in complete remission after two cycles. Cohort 2 receives cycles alternating pralatrexate and brentuximab vedotin combined with cyclophosphamide, doxorubicin, and prednisone. Both groups proceed to allogeneic stem cell transplant if a suitable donor is available and disease is not progressing. Participants are monitored through treatment cycles with evaluations of disease response to guide therapy adjustments. Researchers measure overall response rate at one year as the primary outcome, with event-free survival at two years as a secondary outcome. The study involves close monitoring of organ function, including liver, heart, and lung assessments, and continues until the end of 2028. The total duration varies by participant depending on treatment response and transplant availability.

Chemoimmunotherapy and Allogeneic Stem Cell Transplant for NK T-cell Leukemia/Lymphoma