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
Fred Hutchinson Cancer Center
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.
Description
OUTLINE: This is a phase I dose-escalation study of pralatrexate in combination with bendamustine and TBI followed by a phase II expansion study. Patients receive pralatrexate intravenously (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 peripheral blood stem cell (PBSC) HCT on day 0. Patients also undergo echocardiography (ECHO) or multi-gated acquisition scan (MUGA) and lumbar puncture during screening, positron emission tomography-computed tomography (PET-CT), magnetic resonance imaging (MRI), bone marr…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years with an HCT-Comorbidity Index (CI) ≤ 5 for patients over 60 years * T-cell non-Hodgkin lymphoma (T-NHL) (2022 World Health Organization \[WHO\] criteria) including primary cutaneous T-NHL that is in untreated or unsuccessfully treated first or subsequent relapse. Patients in morphologic remission (i.e. \< 5% blasts in the bone marrow, if involved) but evidence of minimal residual disease (MRD) by positron emission tomography-computed tomography (PET-CT), multiparameter flow cytometry, cytogenetics/fluorescence in situ hybridization (FISH), or molecular mea…
Interventions
- DrugBendamustine
Given IV
- DrugPralatrexate
Given IV
- ProcedureBone Marrow Aspiration
Undergo bone marrow biopsy/aspiration
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy/aspiration
- ProcedureChest Radiography
Undergo chest X-rays
- ProcedureComputed Tomography
Undergo PET-CT
- ProcedureEchocardiography Test
Undergo ECHO
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington