Pralatrexate With Bendamustine and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma

This phase I/II trial studies the side effects and best dose of pralatrexate in combination with bendamustine and total-body irradiation (TBI) followed by a donor stem cell transplant in treating patients with T-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Pralatrexate may block the growth of cancer cells and cause them to die. It is a type of dihydrofolate reductase (DHFR) inhibitor. Bendamustine may damage the DNA in cancer cells and cause them to die. It is a type of alkylating agent and a

Trial Details

NCT ID
NCT07225985
Phase
PHASE1 / PHASE2
Sponsor
Fred Hutchinson Cancer Center
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Bendamustine
  • Pralatrexate
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Chest Radiography
  • Computed Tomography
Locations (sample)
  • Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility Criteria

  • Age ≥ 18 years with an HCT-Comorbidity Index (CI) ≤ 5 for patients over 60 years
  • T-cell non-Hodgkin lymphoma (T-NHL) (2022 World Health Organization \[WHO\] criteria) including primary cutaneous T-NHL that is in untreated or uns…
  • The use of bridging chemotherapy prior to initiation of study treatment is allowed. Patients with symptoms/signs of hyperleukocytosis, white blood …
  • Karnofsky score ≥ 70; Eastern Cooperative Oncology Group (ECOG) 0-1

For full eligibility, visit ClinicalTrials.gov.

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