Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Location status: Recruiting
NCT Number: NCT07353840
This study is a multicenter, two-arm, prospective clinical trial, comprising two groups: the observation group and the autologous hematopoietic stem cell transplantation group (Auto-HSCT). It aims to evaluate the efficacy and safety of Auto-HSCT and observation in the treatment of peripheral T-cell lymphoma that has achieved complete response (CR) after first-line therapy. During the screening/baseline period, informed consent will be obtained, and inclusion/exclusion criteria will be verified. Group assignment (Observation vs. Auto-HSCT) will be determined taking into account the patient's preference. The study plans to enroll 80 patients in each group. Data on demographics and medical history will be collected, and assessments including vital signs, physical examination, PET-CT, bone marrow aspiration smear, flow cytometry, and bone marrow pathology will be performed.
Interested in participating?
Request Info18 year–70 year
All sexes
Observational
Shanghai, Shanghai Municipality, 200080, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1.Ann Arbor Stage I disease. 2.History of any other malignancy within the past 5 years, except for locally curable malignancies that have been treated with curative intent (e.g., basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast).
3.Active infection, including:
5.Pregnant or lactating women, and subjects of childbearing potential unwilling to employ effective contraception.
6.Patients with psychiatric disorders or those unable to provide informed consent.
7.Any other condition which, in the investigator's judgment, makes the subject unsuitable for participation in this study
Auto-HSCT involves the infusion of the patient's own previously collected stem cells.
This is a patient cohort that receives monitoring after first-line therapy with complete response.
Time frame: up to 2 years for the 2y-EFS
Event-free survival (EFS) rates post-transplant. An event is defined as whichever of the following occurs first: disease progression, death from any cause, commencement of new anti-tumor therapy, or a treatment-related serious adverse event (specifically including disabling events or secondary neoplasms). Subjects who were event-free at the data cutoff will be censored on the date of their last tumor assessment.
Time frame: up to 1 years for the 1y-CIR and up to 2 years for the 2y-CIR
The cumulative probability of disease progression (including relapse or progression of the primary disease) within 1 or 2 years after transplantation, with non-progression-related death treated as a competing event.
Time frame: up to 1 years for the DFS
DFS means the time from transplantation until the first occurrence of any of the following events: disease recurrence, disease progression, or death from any cause.
Time frame: up to 1 years for the 1y-OS and up to 2 years for the 2y-OS
The probability of survival at 1 or 2 years, measured from the date of transplantation to death from any cause. Patients who are still alive at the time of analysis will be censored on the last follow-up date.
Contact information is provided by the study sponsor or research team.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Other
Acronym: T-START-CR
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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