Allo-PBSCT as the First-line Treatment for Patients With the High-risk PTCL

Last updated: July 31, 2024
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

Non-hodgkin's Lymphoma

Treatment

allogeneic peripheral blood stem cell transplantation

Clinical Study ID

NCT06509945
SHSYXY-202404-PTCL
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age between 18 and less than 70 years, regardless of gender 2. Peripheral T-celllymphoma (PTCL) was diagnosed according to the 2016 WHO criteria and met any of thefollowing criteria:

  2. High risk: IPI（International Prognostic Index） score ≥ 3 or aaIPI（age-adjustedInternational Prognostic Index） score ≥ 2 ( aaIPI is suitable for patients youngerthan 60 years old).

  3. Patients who achieved complete response (CR) or partial response (PR) afterfirst-line chemotherapy (PET-CT or CT examination was performed according to thepatient 's economic conditions） 3.Patients must have a suitable hematopoietic stemcell 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:

  1. Serum creatinine ≤ 1.5x ULN (the upper limit of normal).

  2. Cardiac function: Ejection fraction ≥ 50%.

  3. Baseline oxygen saturation > 92%.

  4. Total bilirubin ≤ 2.0 x ULN; ALT and AST ≤ 2.0 x ULN，AKP ≤ 2.0 x ULN

  5. Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 (ForcedExpiratory Volume in 1 second) ≥ 50%.

7.Patients must have the ability to understand and be willing to participate in thisstudy and sign an informed consent form.

Exclusion

Exclusion Criteria:

  1. 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 toscreening, except for adequately treated in situ cervical cancer, basal cellcarcinoma, squamous cell carcinoma of the skin, and curatively treatedlocalized 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 3months prior to screening, myocardial infarction within the 3 months prior toscreening, 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 arterialhypertension.

  7. Active, uncontrolled infections, including those associated with hemodynamicinstability, new or worsening infection symptoms or signs, new infectiouslesions on imaging, or persistent unexplained fever without signs or symptomsof infection.

  8. HIV-infected individuals.

  9. Active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviraltherapy.

  10. History of autoimmune diseases

  11. Pregnant or breastfeeding women.

  12. Fertile males and females unwilling to use contraception during the treatmentperiod and for 12 months after treatment.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: allogeneic peripheral blood stem cell transplantation
Phase:
Study Start date:
July 15, 2024
Estimated Completion Date:
July 15, 2026

Connect with a study center

  • Shanghai General Hospital

    Shanghai, Shanghai 200080
    China

    Active - Recruiting

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