High-dose chemotherapy with autologous stem cell transplant versus observation for peripheral T‑cell lymphoma in complete remission

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients who achieved a complete radiologic remission after anthracycline‑based induction chemotherapy are randomized to either standard observation or stem cell mobilization with high‑dose chemotherapy followed by an autologous stem cell transplant. The primary endpoint is progression‑free survival, with overall survival, relapse and mortality rates as key secondary outcomes and minimal residual disease examined as an exploratory objective. Blood samples, optional bone marrow biopsies, and routine CT or PET/CT imaging are collected during follow‑up. Clinical visits and imaging are scheduled regularly, approximately every three months during the initial follow‑up period.

Why it matters

Who can join: the full rules

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 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's running

• Anchorage Associates in Radiation Medicine
  Anchorage, Alaska, United States Recruiting
• Alaska Breast Care and Surgery LLC
  Anchorage, Alaska, United States Recruiting
• Alaska Oncology and Hematology LLC
  Anchorage, Alaska, United States Recruiting
• Alaska Women's Cancer Care
  Anchorage, Alaska, United States Recruiting
• Katmai Oncology Group
  Anchorage, Alaska, United States Recruiting
• Providence Alaska Medical Center
  Anchorage, Alaska, United States Recruiting

+115 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Nabila N Bennani — ECOG-ACRIN Cancer Research Group
• Study coordinator: Pamela Cogliano
• Email: ecog.rss@jimmy.harvard.edu
• Phone: 857-504-2900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.