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RecruitingPriority 4 · Lower priorityNCT07225985

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

ClinicalTrials.gov

Plain-language summary

This Phase 1, Phase 2 trial is evaluating Bendamustine, Pralatrexate, and other medications as a treatment for people newly diagnosed with T-cell lymphoma. The study starts with lower doses to find the safest effective dose before testing in more people. It is available at 1 US location.

Who can join (key eligibility)

  • Age 18 Years or older
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)
  • May require specific number of prior treatments

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

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

Drugs / treatments
Bendamustine, Pralatrexate, Bone Marrow Aspiration, Bone Marrow Biopsy, Chest Radiography, Computed Tomography, Echocardiography Test, Lumbar Puncture, Magnetic Resonance Imaging, Multigated Acquisition Scan, Peripheral Blood Stem Cell Transplantation, Positron Emission Tomography, Questionnaire Administration, Total-Body Irradiation, Biospecimen Collection
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details
TrialCompass — Clinical Trial Summary

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

NCT07225985

Phase: Phase 1, Phase 2 | Status: Recruiting | Priority: Lower

Plain-language summary

This Phase 1, Phase 2 trial is evaluating Bendamustine, Pralatrexate, and other medications as a treatment for people newly diagnosed with T-cell lymphoma. The study starts with lower doses to find the safest effective dose before testing in more people. It is available at 1 US location.

Who can join

  • Age 18 Years or older
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)
  • May require specific number of prior treatments

What's being tested

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

Drugs / treatments: Bendamustine, Pralatrexate, Bone Marrow Aspiration, Bone Marrow Biopsy, Chest Radiography, Computed Tomography, Echocardiography Test, Lumbar Puncture, Magnetic Resonance Imaging, Multigated Acquisition Scan, Peripheral Blood Stem Cell Transplantation, Positron Emission Tomography, Questionnaire Administration, Total-Body Irradiation, Biospecimen Collection

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 50 patients

Primary endpoint: Incidence and severity of treatment-emergent adverse events and treatment-emergent serious adverse events (Phase 1); Proportion of enrolled patients with T-cell non-Hodgkin lymphoma who successfully proceed to allogeneic-hematopoietic cell transplant (HCT) (Phase 2)

Ages: 18 Years to —

Start date: 2026-04-27 | Est. completion: 2030-11-15

Locations

1 US sites · 1 total

Washington

Contact

Lorenzo Iovino, MD, PhD | liovino@fredhutch.org | 206-667-4475

Sponsor: Fred Hutchinson Cancer Center (OTHER)

Tags

All T-cell lymphomas · Newly diagnosed · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT07225985

Prepared using TrialCompass (trialcompass.com) on July 4, 2026. For informational purposes only. Always discuss with your healthcare team.