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NOT YET RECRUITING
NCT07225985
PHASE1/PHASE2

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

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-05-01

Completion Date

2030-11-15

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

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

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States