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High Dose Chemotherapy and Stem Cell Transplant for Peripheral T-Cell Lymphoma

This study is testing whether giving high dose chemotherapy followed by a transplant of your own stem cells (autologous stem cell transplant or ASCT) helps people with certain types of peripheral T-cell lymphoma (a type of blood cancer) live longer without their cancer returning. This is for patients whose cancer completely responded to initial chemotherapy. Researchers want to see if ASCT is better than just watching carefully (observation). The study aims to enroll 294 participants between 18 and 75 years old who have specific types of peripheral T-cell lymphoma, including ALK-negative Anaplastic Large Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma. The main goal is to see if ASCT improves the time until the cancer comes back or death (progression-free survival).

Study design
This is an interventional study, meaning participants will receive a specific treatment or observation. It plans to enroll 294 participants.
What's involved
Participants will either receive standard observation or undergo stem cell mobilization, leukapheresis, high dose chemotherapy, and an autologous stem cell transplant. Both groups will have blood samples collected, and some may have optional bone marrow aspirations and biopsies.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for progression-free survival for up to 12 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06724237

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

Recruiting
PHASE3Ages 18–75InterventionalTreatment
Eastern Cooperative Oncology Group
~294 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:Autologous Hematopoietic Stem Cell TransplantationBest PracticeBiospecimen CollectionBone Marrow AspirationBone Marrow BiopsyComputed Tomography

At a glance

Recruiting sites
142 of 165 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS)
Measured over From study randomization to documented disease progression or death, whichever occurs first, assessed up to 12 years

Conditions

Anaplastic Large Cell Lymphoma, ALK-Negative
Follicular Helper T-Cell Lymphoma
Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type
Peripheral T-Cell Lymphoma, Not Otherwise Specified

Explore related trials

Anaplastic Large Cell LymphomaFollicular Helper T-Cell Lymphoma, Angioimmunoblastic-TypeMature T-Cell and NK-Cell Non-Hodgkin LymphomaPeripheral T-Cell Lymphoma, Not Otherwise Specified

NCT06724237

Where you'd take part

This study runs at 165 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaskastudy coordinator listed

    Recruiting

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaskastudy coordinator listed

    Recruiting

  • Alaska Women's Cancer Care

    Anchorage, Alaskastudy coordinator listed

    Recruiting

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaskastudy coordinator listed

    Recruiting

  • Banner University Medical Center - Tucson

    Tucson, Arizonastudy coordinator listed

    Recruiting

  • Bay Area Hospital

    Coos Bay, Oregonstudy coordinator listed

    Recruiting

  • Beebe Health Campus

    Rehoboth Beach, Delawarestudy coordinator listed

    Recruiting

  • Beebe Medical Center

    Lewes, Delawarestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Nabila N Bennani · PRINCIPAL_INVESTIGATOR · ECOG-ACRIN Cancer Research Group

Who to contact

Pamela Cogliano
[email protected]
857-504-2900
Email the study team

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Eligibility criteria

Inclusion

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 infection requiring intravenous systemic antimicrobial at time of randomization. Antibiotic prophylaxis is acceptable as long as the dose of the medication has been stable for at least 7 days prior to randomization
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse during the treatment phase of the study and thereafter according to institutional guidelines
Absolute neutrophil count (ANC) ≥ 1000/mcL (obtained ≤ 14 days prior to protocol randomization)
Platelets ≥ 75,000/mcL (obtained ≤ 14 days prior to protocol randomization)
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to protocol randomization)
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3.0 x institutional ULN (obtained ≤ 14 days prior to protocol randomization)
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

What this trial measures

  • Progression-free survival (PFS)From study randomization to documented disease progression or death, whichever occurs first, assessed up to 12 years

    Stratified logrank test will be used for the primary analysis of the comparison of PFS between treatment arms. Kaplan-Meier method will be used to visualize and estimate survival function for failure time endpoints. There will be a subgroup analysis for the randomization stratification factors, and other variables measured at baseline.