Actively Recruiting
Phase II Trial of Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
Led by National Cancer Institute (NCI) · Updated on 2026-06-05
330
Participants Needed
2
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Peripheral T-cell lymphomas (PTCL) are a group of blood cancers that often do not respond well to chemotherapy and can cause serious health problems. Researchers are studying different approaches to prepare patients for allogeneic hematopoietic cell transplantation (HCT) to control or cure PTCL, especially for those with lymphoma that has returned or not responded to previous treatments. The trial aims to estimate how well patients survive without disease progression one year after transplant using various conditioning methods. The study includes four main treatment approaches: immunosuppression-only conditioning (IOC), reduced-intensity conditioning (RIC), modified reduced-intensity conditioning (mRIC), and a specific ATL-RIC arm for adult T cell leukemia/lymphoma patients. Each involves combinations of drugs like equine anti-thymocyte globulin, pentostatin, cyclophosphamide, busulfan, filgrastim, ruxolitinib, and zidovudine, given on precise schedules before and after the transplant. All patients receive graft-versus-host disease (GVHD) prevention treatments after transplant. Donors provide stem cells through blood collection, and recipients receive the transplant via catheter after hospital preparation. Participants will undergo detailed screening including physical exams, blood and urine tests, biopsies, imaging scans, and tumor sampling. After the transplant, recipients will be closely monitored in the hospital for several weeks and followed up with visits at 6, 12, 18, and 24 months, then annually for five years. Researchers will measure outcomes like progression-free survival, graft failure, lymphoma relapse, incidence of GVHD, and overall survival. This long-term monitoring helps understand the safety and effectiveness of different transplant conditioning methods.
CONDITIONS
Brief Title
Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years or older
- Diagnosis of peripheral T-cell lymphoma that is relapsed, refractory, or suitable for upfront transplant based on risk score or clinical guidelines
- At least one potentially suitable related or unrelated donor for stem cell transplant
- Adequate heart, lung, liver, and kidney function as specified for transplant
- Karnofsky or Lansky performance status meeting minimum thresholds
- Ability to understand and sign informed consent
- Not pregnant or breastfeeding
- Agreement to use contraception before and for at least one year after transplant if of childbearing potential
You will not qualify if you...
- Use of other investigational agents except virus-specific cytotoxic T-cells prior to transplant
- Allergy to study drugs or similar compounds
- Lack of potential for central venous access
- Active psychiatric disorder compromising compliance or consent
- For unrelated donors, failure to meet National Marrow Donor Program eligibility standards
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 weeks from conditioning start to completion of initial transplant treatment
Participants receive conditioning therapy followed by allogeneic hematopoietic cell transplantation (HCT) with graft-versus-host disease prophylaxis.
Multiple visits around the time of transplantation including days -14 through +60 for treatment and prophylaxis
Duration - Up to 5 years post-transplant
Participants are monitored for transplant outcomes including graft function, graft-versus-host disease, lymphoma relapse, and survival for up to 5 years post-transplant.
Regular visits at multiple intervals including days +21, +28, +35, +42, +60, +100, +180, 1 year, 3 years, and 5 years post-transplant
Trial Site Locations
Total: 2 locations
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
2
National Marrow Donor Program
Minneapolis, Minnesota, United States, 55401
Enrolling by Invitation
Research Team
J
Jessenia C Campos, R.N.
D
Dimana Dimitrova, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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