Distribution of lymphoid neoplasms in Northwest China: Analysis of 3244 cases according to WHO classification in a single institution.
Chun Cao, Juan Feng, Hongtao Gu...
https://pubmed.ncbi.nlm.nih.gov/29661730Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06509945
Allogeneic Peripheral Blood Stem Cell Transplantation as the First-line Treatment for Patients With High-risk Peripheral T-cell Lymphoma
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2024-08-01
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating allogeneic peripheral blood stem cell transplantation as a treatment for patients with high-risk peripheral T-cell lymphoma who have achieved complete or partial response after initial chemotherapy. This single-center, single-arm, prospective phase II trial aims to assess the treatment's safety and effectiveness, focusing on progression-free survival and other important outcomes over a two-year period. Participants will receive the transplantation following a conventional or preferred reduced-intensity conditioning regimen, with donor stem cells infused on day 0. Bone marrow examinations are scheduled on days 14 and 28 post-transplant, then monthly during the first year and every 60 days during the second year. Additionally, PET/CT scans will be done every six months, and extra examinations will be performed if relapse is suspected. The study also monitors complications such as graft-versus-host disease and viral reactivations. Throughout the study, participants will undergo regular bone marrow assessments, imaging scans, and lab tests to track their condition and detect any relapse or complications. Researchers will measure outcomes like progression-free survival at one and two years, relapse rates, overall survival, and occurrences of graft-versus-host disease and viral reactivation. The total follow-up spans up to two years after transplantation to ensure comprehensive safety and effectiveness monitoring.
CONDITIONS
Brief Title
Allo-PBSCT as the First-line Treatment for Patients With the High-risk PTCL
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and less than 70 years, regardless of gender
- Diagnosed peripheral T-cell lymphoma (PTCL) according to the 2016 WHO criteria
- High risk as defined by IPI score ≥ 3 or age-adjusted IPI score ≥ 2 for patients under 60
- Achieved complete response (CR) or partial response (PR) after first-line chemotherapy
- Suitable hematopoietic stem cell donor with minimum HLA matching (related donor: ≥ 5/10; unrelated donor: ≥ 8/10)
- Hematopoietic cell transplantation comorbidity index (HCT-CI) score ≤ 2
- ECOG performance status between 0 and 2
- Adequate liver, kidney, and cardiopulmonary function meeting specified lab and functional criteria
- Ability to understand and willing to participate and sign informed consent
You will not qualify if you...
- PTCL patients not meeting high-risk criteria
- PTCL ALK+ patients with complete response after first-line treatment
- History of malignancies other than lymphoid tumors within 5 years, except certain treated cancers
- ECOG performance status ≥ 3
- HCT-CI score ≥ 3
- Unstable systemic diseases including recent heart or cerebrovascular events, severe arrhythmias, or significant organ diseases
- Active, uncontrolled infections or persistent unexplained fever
- HIV infection
- Active hepatitis B or C requiring antiviral therapy
- History of autoimmune diseases
- Pregnant or breastfeeding women
- Fertile males and females unwilling to use contraception during treatment and for 12 months after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration according to transplantation protocol and participant recovery
Participants who achieved response to first-line chemotherapy will receive allogeneic peripheral blood stem cell transplantation as the first-line treatment.
1 transplantation visit and follow-up visits as per clinical protocol
Follow-up
Duration - Up to 2 years
Participants are monitored for graft-versus-host disease, relapse, survival, and viral reactivation following transplantation.
Regular visits for up to 2 years
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
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Research Team
X
xianmin song, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Subtype distribution of lymphomas in Southwest China: analysis of 6,382 cases using WHO classification in a single institution.
Qun-Pei Yang, Wen-Yan Zhang, Jian-Bo Yu...
https://pubmed.ncbi.nlm.nih.gov/21854649