What is this trial studying for peripheral T-cell lymphoma?

This trial is studying whether high dose chemotherapy followed by autologous stem cell transplant improves progression-free survival compared to observation alone in patients who achieved complete remission after initial chemotherapy. The study aims to provide clearer guidance on the best treatment approach for this lymphoma type. It is sponsored by the Eastern Cooperative Oncology Group.

Who may be eligible for this peripheral T-cell lymphoma clinical trial?

Adults aged 18 to 75 years with peripheral T-cell lymphoma who have completed anthracycline-based chemotherapy and achieved complete remission may be eligible. Participants must be fit for high dose chemotherapy and stem cell transplant and have no active infections needing intravenous antibiotics. Please review eligibility criteria for more details.

Is there any cost to participate in this peripheral T-cell lymphoma clinical trial?

Study-related care, including the high dose chemotherapy, stem cell transplant, and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase 3

Age: 18Years - 75Years

All Genders

ID06724237

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 Following Induction Therapy

Led by Eastern Cooperative Oncology Group · Updated on 2026-05-15

294

Participants Needed

158

Research Sites

291 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether high dose chemotherapy combined with the patient's own stem cell transplant improves outcomes compared to observation only in patients with peripheral T-cell lymphoma who have achieved a complete response after initial chemotherapy. This phase III trial aims to better understand progression-free survival and overall survival differences between these treatment approaches, as well as relapse and mortality rates over a long-term follow-up of up to 12 years. The study also explores the role of minimal residual disease in treatment benefit. Participants are randomly assigned to one of two groups. One group receives standard observation with regular blood sample collection, optional bone marrow biopsy, and imaging scans such as CT or PET/CT. The other group undergoes stem cell mobilization, leukapheresis, high dose chemotherapy, and autologous stem cell transplantation, alongside the same monitoring procedures. After treatment, patients are monitored every 3 months for 2 years, then every 6 months for 3 years, and yearly thereafter, totaling 12 years from enrollment. During the study, participants undergo blood tests, optional bone marrow sampling, and imaging scans to track disease status. Researchers monitor progression-free survival, overall survival, relapse rates, and mortality. The long follow-up period allows for comprehensive assessment of treatment effects and safety. Participants can expect regular visits for assessments and monitoring throughout their involvement in the trial, which lasts up to 12 years from the date of randomization.

CONDITIONS

Brief Title

Testing Whether High Dose Chemotherapy and Infusion of the Patients' Own Stem Cells Improves Survival in Patients With Peripheral T-cell Lymphoma Who Achieved a Complete Response at the End of the Initial Chemotherapy

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Patient is between 18 and 75 years old
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Patient has histologically confirmed peripheral T-cell lymphoma in one of these categories: ALK-negative anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, nodal PTCL with follicular helper T cell phenotype, or PTCL not otherwise specified
Patient has received induction treatment with anthracycline-based chemotherapy and achieved complete remission as defined by Lugano criteria with a Deauville score between 1 and 3 by PET-CT
Patient is eligible for high dose chemotherapy and autologous stem cell transplant according to transplant center guidelines and ready to proceed if randomized to that arm
Patient has no active infection requiring intravenous systemic antibiotics at time of randomization; stable antibiotic prophylaxis is allowed
Patients with prior or concurrent malignancy are eligible if it does not interfere with study safety or efficacy assessment
Female patients must not be pregnant or breastfeeding and must have a pregnancy test within 14 days prior to randomization if of childbearing potential
Patients must agree to use accepted contraception or abstain from conceiving during and after treatment per institutional guidelines
Absolute neutrophil count must be at least 1000/mcL within 14 days prior to randomization
Platelet count must be at least 75,000/mcL within 14 days prior to randomization
Total bilirubin must be at or below 1.5 times the institutional upper limit of normal within 14 days prior to randomization
AST and ALT levels must be at or below 3 times the institutional upper limit of normal within 14 days prior to randomization
HIV-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible
Patients with chronic hepatitis B must have undetectable viral load on suppressive therapy if needed
Patients with hepatitis C must be treated and cured or have undetectable viral load if currently on treatment

You will not qualify if you...

Patient is younger than 18 or older than 75 years
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status above 2
Patient does not have one of the specified peripheral T-cell lymphoma subtypes
Patient has not achieved complete remission after induction chemotherapy
Patient is not eligible for high dose chemotherapy and autologous stem cell transplant
Patient has an active infection requiring intravenous systemic antibiotics
Patient is pregnant or breastfeeding
Patient does not agree to use contraception or abstain from conceiving during and after treatment
Absolute neutrophil count is below 1000/mcL
Platelet count is below 75,000/mcL
Total bilirubin is above 1.5 times the institutional upper limit of normal
AST or ALT levels are above 3 times the institutional upper limit of normal
HIV-infected patients without effective antiretroviral therapy or detectable viral load
Patients with chronic hepatitis B not on suppressive therapy or with detectable viral load
Patients with untreated or active hepatitis C infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Varies based on treatment procedures

Participants randomized to the treatment arm receive stem cell mobilization therapy, leukapheresis, high dose chemotherapy, and autologous stem cell transplant per standard of care. Participants randomized to the observation arm undergo standard of care observation without active treatment.

Multiple visits including procedures for stem cell mobilization, leukapheresis, chemotherapy, and transplant or observation visits

Follow-up

Duration - Up to 12 years from randomization

After completion of treatment or observation, participants are followed up regularly to monitor health status, disease progression, and survival outcomes.

Visits every 3 months for 2 years, every 6 months for 3 years, then yearly visits up to 7 years

Trial Site Locations

Total: 158 locations

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States, 35233

Not Yet Recruiting

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States, 98508

Actively Recruiting

Alaska Breast Care and Surgery LLC