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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT07225985
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Apr 27, 2026
Status verified
May 2026
Primary completion
Sep 30, 2030
Completion
Nov 15, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pralatrexate, bendamustine, TBI, PBSC HCT)
    Patients receive pralatrexate 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 PBSC HCT on day 0. Patients also undergo ECHO or MUGA and lumbar puncture during screening, PET-CT, MRI, bone marrow biopsy/aspiration, and blood sample collection throughout the study. In addition, patients may undergo chest X-rays as clinically indicated.

Primary Outcome Measure

Incidence and severity of treatment-emergent adverse events and treatment-emergent serious adverse events (Phase 1) [ Time Frame: From pralatrexate dosing on day -6 to 28 days post-transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Lorenzo Iovino, MD, PhD
[email protected]
206-667-4475
Lorenzo Iovino, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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