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 (CR1) Following Induction Therapy (PTCL-STAT)
Study on Autologous Stem Cell Transplant for Peripheral T-Cell Lymphoma in Remission
Utpal Dave, MD
Primary Investigator
Brief description of study
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.
Detailed description of study
Prior to enrollment, patients must have already completed induction with an anthracycline based chemotherapy regimen and be in complete remission (CR). Patients will then be randomized to either the Observation arm (Arm A) or the Autologous Stem Cell Transplant arm (Arm B).
ARM I: Patients receive standard of care observation on study. Patients also undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and computed tomography (CT) or positron emission tomography (PET)/CT throughout the study.
ARM II: Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for up to 7 years for a total of 12 years from the date of randomization.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Anaplastic Large Cell Lymphoma, ALK-Negative Follicular Helper T-Cell Lymphoma Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type Peripheral T-Cell Lymphoma, Cancer
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Age: 18 years - 75 years
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Gender: All
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
This study investigates the potential benefits of using high dose chemotherapy followed by a patient's own stem cells, known as an autologous stem cell transplant, in treating peripheral T-cell lymphoma. Peripheral T-cell lymphoma is a type of cancer that affects T-cells, which are part of the body's immune system. The study is focused on patients who have achieved a complete response after their initial chemotherapy. The trial will compare two approaches: one group will continue with standard observation, and the other will receive the high dose chemotherapy and stem cell transplant.
Participants in the study will be divided into two arms. In the first arm, patients will undergo standard observation, including blood tests and optional bone marrow tests, along with CT or PET/CT scans. In the second arm, patients will receive stem cell mobilization, followed by high dose chemotherapy and an autologous stem cell transplant. This involves collecting the patient's stem cells before treatment, administering chemotherapy, and then returning the stem cells to help restore blood-forming cells. Regular monitoring through blood tests, optional bone marrow tests, and imaging scans will be conducted for both groups.
- Who can participate: Adults aged 18 to 75 with peripheral T-cell lymphoma in complete remission after anthracycline-based chemotherapy are eligible. Participants must have a good performance status and meet health criteria, including specific blood counts and liver function tests.
- Study details: Participants will either undergo observation or receive high dose chemotherapy followed by an autologous stem cell transplant. A placebo is not used in this study.
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