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NCT Number: NCT06468267

RIC With Thiotepa Combined With Bu/Flu/Ara-C in Allo-HSCT for Relapsed or Refractory PTCL.

This study is a single-center, single-arm, prospective phase II clinical trial that evaluates the efficacy and safety of an reduced-intensity conditioning (RIC) regimen with thiotepa combined with busulfan, fludarabine, and cytarabine for allogeneic hematopoietic stem cell transplantation in the treatment of relapse and refratory peripheral T-cells lymphoma. The conditioning regimen includes thiotepa at a dose of 5mg/kg/d at d -7 (1 day), fludarabine at 30mg/m2/d from d -6 to d -2 (5 days), cytarabine at 1g/m2/d from d -6 to d -2 (5 days), and busulfan at 3.2mg/kg/d from d -4 to d -3 (2 days). Conditioning begins on day -7, and 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. FDG-PET/CT imaging will be adopted 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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location status: Recruiting

Location contact

Xianmin Song, MD

CONTACT

[email protected]

+86 21 63240090 ext. 3175

Xianmin Song, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and less than 70 years, regardless of gender
  • Peripheral T-cell lymphoma (PTCL) was diagnosed according to the 2016 WHO criteria and met any of the following criteria: Relapse: Except ALK+ anaplastic large cell lymphoma (ALCL), CR was achieved by standard chemotherapy but disease progressed,and relapse after hematopoietic stem cell transplantation;Refractory: Except ALK+ anaplastic large cell lymphoma (ALCL), the tumor shrank < 50% or progressive disease after 4 courses of standard chemotherapy, or not achieve CR after 6 courses of standard chemotherapy;Not suitable for or refusing autologous hematopoietic stem cell transplantation.
  • 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
  • Hematopoietic cell transplantation comorbidity index (HCT-CI) score ≤ 2
  • ECOG (Eastern Cooperative Oncology Group) performance status: 0-2
  • Adequate liver, kidney, and cardiopulmonary function, meeting the following requirements:Serum creatinine ≤ 1.5x ULN (the upper limit of normal);Cardiac function: Ejection fraction ≥ 50%;Baseline oxygen saturation > 92%;Total bilirubin ≤ 2.0 x ULN; ALT and AST ≤ 2.0 x ULN,AKP ≤ 2.0 x ULN;Pulmonary function: DLCO (corrected for hemoglobin) ≥ 40% and FEV1 (Forced Expiratory Volume in 1 second) ≥ 50%
  • Patients must have the ability to understand and be willing to participate in this study and sign an informed consent form

Exclusion criteria

  • PTCL patients did not meet the criteria of relapse / refractory.
  • Refuse to adopt allegeneic hematopoietic stem cell transplantation.
  • 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
  • ECOG ≥ 3.
  • HCT-CI score ≥ 3.
  • 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.
  • 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.
  • HIV-infected individuals.
  • Active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral therapy.
  • History of autoimmune diseases
  • Pregnant or breastfeeding women.
  • Fertile males and females unwilling to use contraception during the treatment period and for 12 months after treatment.

Treatment and study plan

Thiotepa

Drug

The reduced intensity conditioning regimen is composed by thiotepa (5mg / kg / d-7d (1d)), fludarabine (30mg / m2 / d, -6d--2d (5d)), Ara-C (1g / m2 / d, -6d--2d (5d)), and busulfan (3.2mg / kg / d, -4d-3d (2d)).

Other names: fludarabine, busulfan, Cytarabine

Primary outcomes

  1. 1y and 2y-progression-free survival (PFS)

    Time frame: 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 outcomes

  1. acute graft-versus-host disease (aGVHD)

    Time frame: up to 180 days

    acute graft-versus-host disease (aGVHD) within 180 days post-transplant

  2. 1y and 2y-cumulative relapse rates (CIR)

    Time frame: 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

  3. 1y and 2y-overall survival (OS)

    Time frame: 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

  4. graft-versus-host disease-free, relapse-free survival (GRFS)

    Time frame: up to 2 years

    graft-versus-host disease-free, relapse-free survival (GRFS) at 2 years post-transplant

  5. non-relapse mortality (NRM)

    Time frame: up to 2 years

    non-relapse mortality (NRM) at 2 years post-transplant

  6. cumulative incidence of chronic GVHD

    Time frame: up to 2 years

    cumulative incidence of chronic GVHD at 2 years post-transplant

  7. CMV and EBV reactivation

    Time frame: up to 1 year

    the incidence of CMV and EBV reactivation within 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

xianmin Song, MD

CONTACT

[email protected]

+86 1350167250

Sponsors and collaborators

Lead sponsor

Xianmin Song, MD

Other

Registry information

Official study title

Reduced Intensity Conditioning With Thiotepa Combined With Busulfan, Fludarabine and Cytarabine in Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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