Allo-PBSCT as the First-line Treatment for Patients With the High-risk PTCL
- Conditions
- Peripheral T Cell Lymphoma
- Interventions
- Other: allogeneic peripheral blood stem cell transplantation
- Registration Number
- NCT06509945
- Lead Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Brief Summary
This study is a single-center, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of allogeneic peripheral blood stem cell transplantation in the treatment of high-risk peripheral T-cells lymphoma patients achieved complete response (CR) or partial response (PR). Conventional conditioning regimen is adopted while the reduced-intensity conditioning regimens will be preferred. Donor hematopoietic stem cell infusion is performed on day 0. All patients will undergo bone marrow examination on day 14 and day 28 post-transplant, followed by bone marrow examinations every 30 days within the first year after transplantation, and every 60 days within the second year after transplantation. Positron emission tomography with 2-deoxy-2-\[fluorine-18\]fluoro-D-glucose integrated with computed tomography (18F-FDG PET/CT) imaging will be performed every 6 months after transplantation. If disease relapse is suspected during the follow-up period, bone marrow and relapse site examinations will be conducted at any time. The primary study endpoints are the 1-year and 2-year progression-free survival (PFS) rates post-transplant. Secondary study endpoints include the incidence of acute graft-versus-host disease (GVHD) within 180 days post-transplant, cumulative relapse rates at 1 year and 2 years post-transplant, 1-year and 2-year overall survival (OS), graft-versus-host disease-free, relapse-free survival (GRFS), non-relapse mortality (NRM), cumulative incidence of chronic GVHD, and the incidence of Cytomegalovirus （CMV）and Epstein-Barr virus（EBV）reactivation within 1 year.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
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Age between 18 and less than 70 years, regardless of gender 2. Peripheral T-cell lymphoma (PTCL) was diagnosed according to the 2016 WHO criteria and met any of the following criteria:
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High risk: IPI（International Prognostic Index） score ≥ 3 or aaIPI（age-adjusted International Prognostic Index） score ≥ 2 ( aaIPI is suitable for patients younger than 60 years old).
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Patients who achieved complete response (CR) or partial response (PR) after first-line chemotherapy (PET-CT or CT examination was performed according to the patient 's economic conditions） 3.Patients must have a suitable hematopoietic stem cell donor:
Related donors must have at least 5/10 matches for HLA-A, -B, -C, -DQB1, and - DRB1.
Unrelated donors must have at least 8/10 matches for HLA-A, -B, -C, -DQB1, and -DRB1.
4.Hematopoietic cell transplantation comorbidity index (HCT-CI) score ≤ 2. 5.ECOG (Eastern Cooperative Oncology Group) performance status: 0-2. 6.Adequate liver, kidney, and cardiopulmonary function, meeting the following requirements:
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Serum creatinine ≤ 1.5x ULN (the upper limit of normal).
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Cardiac function: Ejection fraction ≥ 50%.
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Baseline oxygen saturation > 92%.
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Total bilirubin ≤ 2.0 x ULN; ALT and AST ≤ 2.0 x ULN，AKP ≤ 2.0 x ULN
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Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 (Forced Expiratory Volume in 1 second) ≥ 50%.
7.Patients must have the ability to understand and be willing to participate in this study and sign an informed consent form.
- PTCL patients did not meet the criteria of high-risk. 2. PTCL ALK + patients with CR after first-line treatment. 3. History of malignancies other than lymphoid tumors within the 5 years prior to screening, except for adequately treated in situ cervical cancer, basal cell carcinoma, squamous cell carcinoma of the skin, and curatively treated localized prostate cancer or ductal carcinoma in situ 4. ECOG ≥ 3. 5. HCT-CI score ≥ 3. 6. Any unstable systemic diseases, including but not limited to unstable angina, recent cerebrovascular accidents or transient ischemic attacks within the 3 months prior to screening, myocardial infarction within the 3 months prior to screening, congestive heart failure (New York Heart Association [NYHA] class ≥ III), severe arrhythmias requiring drug treatment after pacemaker implantation, significant liver, kidney, or metabolic diseases, and pulmonary arterial hypertension. 7. Active, uncontrolled infections, including those associated with hemodynamic instability, new or worsening infection symptoms or signs, new infectious lesions on imaging, or persistent unexplained fever without signs or symptoms of infection. 8. HIV-infected individuals. 9. Active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral therapy. 10. History of autoimmune diseases 11. Pregnant or breastfeeding women. 12. Fertile males and females unwilling to use contraception during the treatment period and for 12 months after treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description intervention arm allogeneic peripheral blood stem cell transplantation Participants will receive allogeneic peripheral blood stem cell transplantation.
- Primary Outcome Measures
Name Time Method 1y and 2y-progression-free survival (PFS) up to 1 years for the 1y-PFS and up to 2 years for the 2y-PFS 1-year and 2-year progression-free survival (PFS) rates post-transplant
- Secondary Outcome Measures
Name Time Method cumulative incidence of chronic graft-versus-host disease (cGVHD) up to 2 years cumulative incidence of chronic graft-versus-host disease (cGVHD) at 2 years post-transplant
graft-versus-host disease-free and relapse-free survival (GRFS) up to 2 years graft-versus-host disease-free and relapse-free survival (GRFS) at 2 years post-transplant
Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) reactivation up to 1 year the incidence of CMV and EBV reactivation within 1 year
non-relapse mortality (NRM) up to 2 years non-relapse mortality (NRM) at 2 years post-transplant
1y and 2y-overall survival (OS) up to 1 years for the 1y-OS and up to 2 years for the 2y-OS overall survival (OS) at 1 year and 2 years post-transplant
acute graft-versus-host disease (aGVHD) up to 180 days acute graft-versus-host disease (aGVHD) within 180 days post-transplant
1y and 2y-cumulative relapse rates (CIR) up to 1 years for the 1y-CIR and up to 2 years for the 2y-CIR cumulative relapse rates (CIR) at 1 year and 2 years post-transplant
Trial Locations
- Locations (1)
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China