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

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.

Conditions

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

Interventions

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

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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Lorenzo Iovino, MD, PhD · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-27

Primary Completion

2030-09-30

Completion

2030-11-15

FDA Drug

Yes

Countries

• United States

Study Locations