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

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05559008
Collaborator
(none)
116
1
4
39.9
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
116 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Umbrella Study in Relapsed/Refractory Peripheral T-cell Lymphoma Guided by Molecular Subtypes
Actual Study Start Date :
Sep 30, 2022
Anticipated Primary Completion Date :
Mar 26, 2024
Anticipated Study Completion Date :
Jan 26, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: T1 subtypes based on next generation sequencing results

T1 subtypes based on next generation sequencing results

Drug: Azacitidine Injection
Azacitidine Injection,SC and Dasatinib PO will be administered in T1 subtypes

Drug: Dasatinib
Azacitidine Injection,SC and Dasatinib PO will be administered in T1 subtypes

Experimental: T2 subtypes based on next generation sequencing results

T2 subtypes based on next generation sequencing results

Drug: Azacitidine Injection
Azacitidine Injection,SC and Dasatinib PO will be administered in T1 subtypes

Drug: Linperlisib
Azacitidine Injection,SC and Linperlisib PO will be administered in T2 subtypes

Experimental: T3.1 subtypes based on next generation sequencing results

T3.1 subtypes based on next generation sequencing results

Drug: Tucidinostat
Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes

Drug: SHR2554
Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes

Experimental: T3.2 subtypes based on next generation sequencing results

T3.2 subtypes based on next generation sequencing results

Drug: Camrelizumab
Camrelizumab and Apatinib will be administered in T3.2 subtypes

Drug: Apatinib
Camrelizumab and Apatinib will be administered in T3.2 subtypes

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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<1.0×109/L Platelets<75×109/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.

  1. HIV-infected patients

  2. Active hepatitis infection

  3. Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol

  4. Pregnant or lactation

  5. Other medical conditions determined by the researchers that may affect the study For T3.2 should exclude patiens with active autoimmune disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200025

Sponsors and Collaborators

  • Ruijin Hospital

Investigators

  • Study Chair: Weili Zhao, Ruijin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhao Weili, First Deputy Director, Hematology Department, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT05559008
Other Study ID Numbers:
  • PTCL-IIT-umbrella
First Posted:
Sep 29, 2022
Last Update Posted:
Nov 9, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2022