Targeted therapies for relapsed or refractory peripheral T-cell lymphoma based on molecular subtypes

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

This study is testing if targeted treatments based on the specific type of peripheral T-cell lymphoma can help patients whose cancer has come back or hasn’t responded to previous treatments.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05559008 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, open-label interventional study aims to evaluate the efficacy and safety of targeted therapies in patients with relapsed or refractory peripheral T-cell lymphoma, guided by their molecular subtypes. Participants will receive treatments such as Azacitidine, Dasatinib, Linperlisib, Tucidinostat, and SHR2554, depending on their specific tumor characteristics. The study will assess the response to these therapies using imaging techniques like PET-CT or CT scans to determine the effectiveness of the interventions.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically-confirmed peripheral T-cell lymphoma who have relapsed or refractory disease after first-line treatment.

Not a fit: Patients with central nervous system lymphoma or those with uncontrolled comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more personalized treatment approach for patients with relapsed or refractory peripheral T-cell lymphoma, potentially improving outcomes.

How similar studies have performed: Other studies have shown promise in using targeted therapies based on molecular subtypes for similar conditions, indicating potential success for this approach.

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

Where this trial is running

Shanghai, Shanghai

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Weili Zhao

Conditions: Peripheral T Cell Lymphoma