Purpose of this Study
We are doing this study to compare the results of typical chemotherapy on its own to high dose chemotherapy followed by stem cell infusion after completing the usual chemotherapy. We want to know which option has the best outcomes for people with periperhal T-cell lymphoma.
Who Can Participate?
Eligibility
Adults ages 18-75 who:
- Are diagnosed with peripheral T-cell lymphoma in one of the following categories: anaplastic large cell lymphoma (ALCL) ALK-negative, or angioimmunoblastic T-cell lymphoma (AITL), or nodal peripheral T-cell lymphoma with TFH phenotype, or peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
- Have previously been treated with an anthracycline based chemotherapy
- Are eligible to receive high dose chemotherapy and autologous stem cell transplant
Age Range
18-75
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (by chance) to 1 of 2 groups:
- Group 1: If you are in this group, you will be observed once a year without any additional treatments unless your disease recurs. If that were to occur, you would be treated under your cancer doctor's guidance, which may also include the possibility of receiving a stem cell transplant as an option if you are eligible for it.
- Group 2: If you are in this group, you will undergo stem cell collection, then you will receive high dose chemotherapy followed by getting your own stem cells as an infusion. You will receive the necessary supportive care measures after that until your transplanted stem cells recover. You will then be observed without any additional treatments unless your disease recurs.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
EA4232: A Randomized Phase III Study to Evaluate Benefits of Autologous Stem Cell Transplant in Patients with Peripheral T Cell Lymphoma That Achieved a First Complete Remission (CR1) Following Induction Therapy (PTCL-STAT)
Principal Investigator
Jie
Wang
Protocol Number
PRO00118003
NCT ID
NCT06724237
Phase
III
Enrollment Status
Pending Open to Enrollment