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New treatment option for Peripheral T Cell Lymphoma
Official title Allo-PBSCT as the First-line Treatment for Patients With the High-risk PTCL
ClinicalTrials.gov ID: NCT06509945
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- High risk: IPI（International Prognostic Index） score ≥ 3 or aaIPI（age-adjusted International Prognostic Index） score ≥ 2 ( aaIPI is suitable for...
- Patients who achieved complete response (CR) or partial response (PR) after first-line chemotherapy (PET-CT or CT examination was performed according...
- Serum creatinine ≤ 1.5x ULN (the upper limit of normal).
- Cardiac function: Ejection fraction ≥ 50%.
You likely can't join if
- PTCL patients did not meet the criteria of high-risk.
- PTCL ALK + patients with CR after first-line treatment.
- History of malignancies other than lymphoid tumors within the 5 years prior to screening, except for adequately treated in situ cervical cancer...
- 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...
See the full eligibility 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:
- 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).
- 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...
- 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%. 7.Patients must have the ability to understand and be willing to participate in this study and sign an...
- PTCL patients did not meet the criteria of high-risk.
- PTCL ALK + patients with CR after first-line treatment.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.