Actively Recruiting

Phase 2
Age: 12Years - 120Years
All Genders
Healthy Volunteers
NCT03922724

Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma

Led by National Cancer Institute (NCI) · Updated on 2026-04-28

330

Participants Needed

2

Research Sites

602 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: Lymphoma is a type of blood cancer. Blood cell transplant can cure some people with lymphoma. Researchers want to see if they can limit the complications transplant can cause. Objective: To test if a stem cell transplant can cure or control lymphoma. Also to test if new ways of getting a recipient ready for a transplant may result in fewer problems and side effects. Eligibility: Recipients: People ages 12 and older with peripheral T cell lymphoma that does not respond to standard treatments Donors: Healthy people ages 18 and older whose relative has lymphoma Design: Participants will be screened with: Physical exam Blood and urine tests Bone marrow biopsy: A needle inserted into the participant s hip bone will remove marrow. Donors will also be screened with: X-rays Recipients will also be screened with: Lying in scanners that take pictures of the body Tumor sample Donors may donate blood. They will take daily shots for 5 7 days. They will have apheresis: A machine will take blood from one arm and take out their stem cells. The blood will be returned into the other arm. Recipients will be hospitalized at least 2 weeks before transplant. They will get a catheter: A plastic tube will be inserted into a vein in the neck or upper chest. They will get antibody therapy or chemotherapy. Recipients will get the transplant through their catheter. Recipients will stay in the hospital several weeks after transplant. They will get blood transfusions. They will take drugs including chemotherapy for about 2 months. Recipients will have visits 6, 12, 18, 24 months after transplant, then once a year for 5 years.

CONDITIONS

Official Title

Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma

Who Can Participate

Age: 12Years - 120Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 12 years or older
  • Diagnosis of peripheral T-cell lymphoma confirmed by pathology that is relapsed, refractory, or at risk level where upfront transplant is reasonable
  • At least one suitable 7-8/8 HLA-matched related or unrelated donor, or an HLA-haploidentical related donor
  • Adequate heart function (specific ejection fraction and shortening fraction thresholds depending on treatment arm)
  • Adequate lung function (specific pulmonary function test thresholds or no dyspnea and oxygen saturation >92% for pediatric patients)
  • Bilirubin, ALT, and AST levels within specified limits unless approved by a hepatologist
  • Estimated creatinine clearance of 50 mL/min/1.73 m2 or higher
  • Karnofsky or Lansky performance status of 50% or higher (RIC arm) or 30% or higher (IOC arm), or ECOG performance status of 2 or less (RIC arm) or 3 or less (IOC arm)
  • Ability to understand and sign informed consent
  • Not pregnant or breastfeeding
  • Agreement to use adequate contraception if of childbearing potential or able to father children
Not Eligible

You will not qualify if you...

  • Receiving other investigational agents except virus-specific cytotoxic T-cells for viral infection treatment prior to transplant
  • Allergy to study drugs or similar compounds
  • Lack of potential for central venous access
  • Active psychiatric disorder that may affect compliance or informed consent
  • For unrelated donors, failure to qualify as a National Marrow Donor Program donor per standards

AI-Screening

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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

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Research Team

J

Jessenia C Campos, R.N.

CONTACT

D

Dimana Dimitrova, M.D.

CONTACT

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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