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 now · Phase 3

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT06724237
Run by: Eastern Cooperative Oncology Group
People needed: 294
Starts: 2025-01-30
Expected to finish: 2033-12-01
Last updated by the study team: 2026-07-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States (enrolling)
Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)
Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States (enrolling)
Medical Oncology Hematology Consultants PA — Newark, Delaware, United States (enrolling)
Christiana Care Health System-Wilmington Hospital — Wilmington, Delaware, United States (enrolling)
Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States (enrolling)
Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States (enrolling)
Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States (enrolling)
Beebe Medical Center — Lewes, Delaware, United States (enrolling)
Helen F Graham Cancer Center — Newark, Delaware, United States (enrolling)
Beebe Health Campus — Rehoboth Beach, Delaware, United States (enrolling)
City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States (enrolling)
Providence Alaska Medical Center — Anchorage, Alaska, United States (enrolling)
Providence Queen of The Valley — Napa, California, United States (enrolling)
UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States (enrolling)
Providence Medical Foundation - Santa Rosa — Santa Rosa, California, United States (enrolling)
Providence Santa Rosa Memorial Hospital — Santa Rosa, California, United States (enrolling)
Banner University Medical Center - Tucson — Tucson, Arizona, United States (enrolling)
Alaska Women's Cancer Care — Anchorage, Alaska, United States (enrolling)
University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States (enrolling)
Beebe South Coastal Health Campus — Millville, Delaware, United States (enrolling)
Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States (enrolling)
Katmai Oncology Group — Anchorage, Alaska, United States (enrolling)
Moffitt Cancer Center-International Plaza — Tampa, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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