A Umbrella Study in R/R PTCL Guided by Molecular Subtypes

Peripheral T Cell Lymphoma Clinical Trial

Official title:

A Umbrella Study in Relapsed/Refractory Peripheral T-cell Lymphoma Guided by Molecular Subtypes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05559008
• Other study ID #: PTCL-IIT-umbrella
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 30, 2022
• Est. completion date: January 26, 2026

Study information

• Verified date: November 2022
• Source: Ruijin Hospital
• Contact: Weili Zhao
• Phone: +862164370045
• Email: zwl_trial[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: January 26, 2026
• Est. primary completion date: March 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T Cell Lymphoma

Intervention

Drug:
• Azacitidine Injection
Azacitidine Injection,SC and Dasatinib PO will be administered in T1 subtypes
• Dasatinib
Azacitidine Injection,SC and Dasatinib PO will be administered in T1 subtypes
• Linperlisib
Azacitidine Injection,SC and Linperlisib PO will be administered in T2 subtypes
• Tucidinostat
Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes
• SHR2554
Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes
• Camrelizumab
Camrelizumab and Apatinib will be administered in T3.2 subtypes
• Apatinib
Camrelizumab and Apatinib will be administered in T3.2 subtypes

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	Percentage of participants with complete and partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.	End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6)(each cycle is 28 days)
Secondary	Complete response rate	Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.	End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6)(each cycle is 28 days)
Secondary	Progression-free survival	Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.	Baseline up to data cut-off (up to approximately 2 years)
Secondary	Overall survival	Overall survival was defined as the time from the date of enrollment to the date of death from any cause.	Baseline up to data cut-off (up to approximately 2 years)
Secondary	Duration of response	Duration of response was defined as the time from the date of favorable response until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria	Baseline up to data cut-off (up to approximately 2 years)
Secondary	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0	An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.	From enrollment to study completion, a maximum of 4 years