Clinical trial NCT05559008: A Umbrella Study in R/R PTCL Guided by Molecular Subtypes
Official title: A Umbrella Study in Relapsed/Refractory Peripheral T-cell Lymphoma Guided by Molecular Subtypes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Peripheral T Cell Lymphoma
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, prospective, open-label, interventional umbrella study to evaluate the efficacy and safety of targeted therapies guided by molecular subtypes in patients with relasped or refractory peripheral T-cell lymphoma.


Eligibility criteria: Inclusion Criteria:

1. Histologically-confirmed Peripheral T-cell lymphoma (without central nervous system involvement)
2. Relapsed or refractory disease after first line treatment
3. Availability of archival or freshly collected tumor tissue before study enrollment
4. Evaluable lesion by PET-CT or CT scan
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
6. Life expectancy greater than or equal to (\>/=) 3 months
7. Informed consent

Exclusion Criteria:

1. Patients with central nervous system (CNS) lymphoma
2. History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
3. Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
4. Laboratory measures meet the following criteria at screening (unless caused by lymphoma):

   Neutrophils\<1.0×10\^9/L Platelets\<75×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement) ALT or AST is 2.5 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.

   Creatinine is 1.5 times higher than the ULN.
5. HIV-infected patients
6. Active hepatitis infection
7. Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
8. Pregnant or lactation
9. Other medical conditions determined by the researchers that may affect the study For T3.2 should exclude patiens with active autoimmune disease

Primary outcomes:
measure: Overall response rate
timeFrame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)
Secondary outcomes:
measure: Complete response rate
timeFrame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)
measure: Progression-free survival
timeFrame: Baseline up to data cut-off (up to approximately 2 years)
measure: Overall survival
timeFrame: Baseline up to data cut-off (up to approximately 2 years)
measure: Duration of response
timeFrame: Baseline up to data cut-off (up to approximately 2 years)
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
timeFrame: From enrollment to study completion, a maximum of 4 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Weili Zhao
role: STUDY_CHAIR
References: