Allogeneic stem cell transplantation for high-risk peripheral T cell lymphoma

Allogeneic Peripheral Blood Stem Cell Transplantation as the First-line Treatment for Patients With the High-risk Peripheral T Cell Lymphoma

This study is testing if a type of stem cell transplant can help people with high-risk peripheral T-cell lymphoma who have responded to their first round of chemotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06509945 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of allogeneic peripheral blood stem cell transplantation as a first-line treatment for patients with high-risk peripheral T-cell lymphoma who have achieved a complete or partial response after initial chemotherapy. The study is conducted at a single center and utilizes a conventional conditioning regimen, with a preference for reduced-intensity conditioning. Patients will undergo regular follow-up assessments, including bone marrow examinations and PET/CT imaging, to monitor for disease relapse and overall treatment response.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with high-risk peripheral T-cell lymphoma who have responded to initial chemotherapy and have a suitable stem cell donor.

Not a fit: Patients who do not meet the eligibility criteria, such as those with a higher HCT-CI score or without a suitable donor, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new first-line option for patients with high-risk peripheral T-cell lymphoma, potentially improving their chances of long-term remission.

How similar studies have performed: Other studies have shown promising results with allogeneic stem cell transplantation in similar patient populations, indicating that this approach has potential based on previous findings.

Eligibility criteria

Inclusion Criteria:

1\. 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:

1. 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).
2. 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:

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 (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.

   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 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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: xianmin Song, MD — Shanghai General HospitalShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: xianmin song, MD

Conditions Peripheral T Cell Lymphoma; peripheral T cell lymphoma; allogeneic peripheral blood stem cell transplantation; high-risk