NCT07225985

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

Pralatrexate and Bendamustine With 3 Gy TBI as a New Reduced Intensity Conditioning (RIC) Regimen for Allogeneic HCT for T-Cell Lymphoma Patients Who Are in Untreated R/R, or in Remission With MRD

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 type of antimetabolite. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TBI is a type of radiation therapy that is given to the entire body. Giving pralatrexate with bendamustine and TBI before a donor stem cell transplant may help kill cancer cells in the body and help make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.

Detailed description

OUTLINE: This is a phase I dose-escalation study of pralatrexate in combination with bendamustine and TBI followed by a phase II expansion study. Patients receive pralatrexate intravenously (IV) over 3-5 minutes on day -6, bendamustine IV over 60 minutes on days -5, -4, and -3, and TBI on day -1 or 0. Patients then undergo peripheral blood stem cell (PBSC) HCT on day 0. Patients also undergo echocardiography (ECHO) or multi-gated acquisition scan (MUGA) and lumbar puncture during screening, positron emission tomography-computed tomography (PET-CT), magnetic resonance imaging (MRI), bone marrow biopsy/aspiration, and blood sample collection throughout the study. In addition, patients may undergo chest X-rays as clinically indicated. After completion of study treatment, patients are followed up at 6 and 9 months and at 1, 1.5 and 2 years.

Conditions

• Recurrent T-Cell Non-Hodgkin Lymphoma
• Refractory T-Cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Bendamustine	Given IV
DRUG	Pralatrexate	Given IV
PROCEDURE	Bone Marrow Aspiration	Undergo bone marrow biopsy/aspiration
PROCEDURE	Bone Marrow Biopsy	Undergo bone marrow biopsy/aspiration
PROCEDURE	Chest Radiography	Undergo chest X-rays
PROCEDURE	Computed Tomography	Undergo PET-CT
PROCEDURE	Echocardiography Test	Undergo ECHO
PROCEDURE	Lumbar Puncture	Undergo lumbar puncture
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Multigated Acquisition Scan	Undergo MUGA
PROCEDURE	Peripheral Blood Stem Cell Transplantation	Undergo PBSC HCT
PROCEDURE	Positron Emission Tomography	Undergo PET-CT
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Total-Body Irradiation	Undergo TBI
PROCEDURE	Biospecimen Collection	Undergo blood sample collection

Timeline

• Start date: 2026-05-01
• Primary completion: 2030-09-30
• Completion: 2030-11-15
• First posted: 2025-11-10
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study