RecruitingPhase 3

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

United States294 participantsStarted 2025-01-30

Plain-language summary

This phase III trial compares the effect of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Usual treatment after a complete response may include observation or high dose chemotherapy followed by an autologous stem cell transplant, however, it is not known if a transplant if beneficial. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. Giving high dose chemotherapy followed by an autologous stem cell transplant may be more effective compared to observation only in treating patients with peripheral T-cell lymphoma who have achieved a complete response after initial chemotherapy.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient must be 18 to 75 years of age * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patient must have histologically proven peripheral T-cell lymphoma (PTCL) in one of the following categories: * Anaplastic large cell lymphoma (ALCL) ALK-negative * Angioimmunoblastic T-cell lymphoma (AITL) * Nodal PTCL with follicular helper T cell (TFH) phenotype * Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) * Patient must have undergone induction treatment with an anthracycline based chemotherapy. * NOTE: Patients who discontinued anthracycline during treatment are eligible as long as they received at least one dose and achieved complete remission * Patient must have achieved radiologic complete remission following induction therapy as defined by the Lugano criteria with a Deauville score between 1-3 by PET-CT * NOTE: There is no central review required. Confirmation of complete remission status is determined by the enrolling institution's review * NOTE: If a patient had a positive bone marrow biopsy at the time of initial diagnosis (pre-induction), a repeat biopsy must be completed post induction to confirm complete remission (CR) * Patient must be eligible for high dose chemotherapy and autologous stem cell transplant (ASCT) per the enrolling institutional guidelines at the transplant center and be ready to proceed with ASCT if randomized to the ASCT arm * Patient must not have active inf…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 3 trial testing high-dose chemotherapy followed by my own stem cells — does that mean it's still being compared against standard treatment, and how confident can we be in its safety and benefit at this stage?
2The trial is specifically for people with peripheral T-cell lymphoma who achieved a complete response after their first round of chemotherapy — if I've reached complete response, is this the right moment to discuss whether this trial is worth considering, or should I first pursue other standard options?
3The trial is measuring progression-free survival as its main goal — can you help me understand what that means practically, such as how long remission might last compared to what I could expect without the transplant?
4Since this involves collecting and storing my own stem cells and then receiving high-dose chemotherapy, what does that process actually look like day-to-day, and how disruptive would it be to my work and family life over the course of treatment?
5My specific diagnosis is one of the subtypes listed — like ALK-negative anaplastic large cell lymphoma or follicular helper T-cell lymphoma — and I want to know whether my particular subtype tends to respond better or worse to this kind of stem cell consolidation approach compared to the others in the study?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression-free survival (PFS)

Timeframe: From study randomization to documented disease progression or death, whichever occurs first, assessed up to 12 years

Trial details

NCT IDNCT06724237

SponsorEastern Cooperative Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2028-04-30

Contact for this trial

Pamela Cogliano

857-504-2900 ecog.rss@jimmy.harvard.edu

View on ClinicalTrials.gov More Anaplastic Large Cell Lymphoma, ALK-Negative trials