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

Phase 1

Recruiting

• Conditions: Peripheral T Cell Lymphoma
• Interventions: Drug: Azacitidine Injection; Drug: Tucidinostat; Drug: Camrelizumab; Drug: Linperlisib; Drug: SHR2554; Drug: Apatinib; Drug: Dasatinib

• Registration Number: NCT05559008
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-25
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-29
• Study Start: 2022-09-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-09
• Primary Completion: 2024-03-26
• Study Completion: 2026-01-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
T1 subtypes based on next generation sequencing results	Azacitidine Injection	T1 subtypes based on next generation sequencing results
T2 subtypes based on next generation sequencing results	Azacitidine Injection	T2 subtypes based on next generation sequencing results
T2 subtypes based on next generation sequencing results	Linperlisib	T2 subtypes based on next generation sequencing results
T3.1 subtypes based on next generation sequencing results	Tucidinostat	T3.1 subtypes based on next generation sequencing results
T3.1 subtypes based on next generation sequencing results	SHR2554	T3.1 subtypes based on next generation sequencing results
T3.2 subtypes based on next generation sequencing results	Camrelizumab	T3.2 subtypes based on next generation sequencing results
T3.2 subtypes based on next generation sequencing results	Apatinib	T3.2 subtypes based on next generation sequencing results
T1 subtypes based on next generation sequencing results	Dasatinib	T1 subtypes based on next generation sequencing results

Primary Outcome Measures

Name	Time	Method
Overall response rate	End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)	Percentage of participants with complete and partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

Secondary Outcome Measures

Name	Time	Method
Complete response rate	End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)	Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Progression-free survival	Baseline up to data cut-off (up to approximately 2 years)	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.
Overall survival	Baseline up to data cut-off (up to approximately 2 years)	Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
Duration of response	Baseline up to data cut-off (up to approximately 2 years)	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
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0	From enrollment to study completion, a maximum of 4 years	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.

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China