Actively Recruiting
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
Led by Fred Hutchinson Cancer Center · Updated on 2026-05-11
50
Participants Needed
1
Research Sites
237 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with an HCT-Comorbidity Index of 5 or less for patients over 60 years
- Diagnosis of T-cell non-Hodgkin lymphoma including primary cutaneous T-NHL in untreated or unsuccessfully treated relapse
- Patients in remission with minimal residual disease detected by PET-CT, flow cytometry, cytogenetics, or molecular methods
- Bridging chemotherapy allowed before study treatment for high tumor burden or complications
- Karnofsky score of 70 or higher and ECOG performance status 0-1
- Adequate heart function without decompensated heart failure or uncontrolled arrhythmia and left ventricular ejection fraction 45% or higher
- Bilirubin level 2.5 times or less than institutional upper limit unless due to lymphoma, Gilbert's syndrome, or hemolysis
- Adequate lung function without oxygen requirement and DLCO corrected 70% or higher or 60-69% with oxygen pressure 70 mmHg or higher
- Creatinine clearance 60 mL/min or higher
- Prior autologous stem cell transplant allowed if relapse occurred more than 6 months after transplant
- An HLA-matched sibling, unrelated, mismatched unrelated, or haploidentical donor identified and available
- Prior sensitivity to pralatrexate or bendamustine with MRD negative complete response lasting 1 year may be considered case-by-case
- Ability to understand and sign informed consent
- Related donor must be genotypically or phenotypically identical for HLA-A, B, C, DRB1, and DQB1 confirmed by high-resolution typing
- Matched unrelated donor must be matched or single allele mismatched without antigen mismatching at HLA-A, B, or C with additional donor compatibility testing
- Mismatched unrelated donors allowed with defined HLA mismatching patterns
- Haploidentical donors must be relatives sharing at least 5 of 10 HLA loci, age 18 or older, weight 40 kg or more, and meet accreditation and screening criteria
- Donor selection preferences include CMV serostatus and red blood cell compatibility
You will not qualify if you...
- Active central nervous system disease
- Serious illness likely to limit survival to less than 1 year
- Active uncontrolled fungal, bacterial, viral, or other infections unless controlled or stable
- Known allergy or contraindication to any study drug
- Pregnancy or breastfeeding
- Receiving other approved or investigational anti-lymphoma treatments at conditioning start
- Presence of anti-donor-specific antibodies with mean fluorescent intensity 5000 or higher after desensitization treatment in haploidentical donor cases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
L
Lorenzo Iovino, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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