Genotype-guided Treatment in PTCL - Clinical Trial for Peripheral T Cell Lymphoma | NCT05675813

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

CHOP+selinexor+5-Azacitidine

CHOP+duvelisib+5-Azacitidine

CHOP+chidamide+tislelizumab

About this trial

This is an interventional treatment trial for Peripheral T Cell Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically-confirmed Peripheral T-cell lymphoma Availability of archival or freshly collected tumor tissue before study enrollment Evaluable lesion by PET-CT or CT scan Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 Life expectancy greater than or equal to (>/=) 3 months Informed consent Exclusion Criteria: Patients with central nervous system (CNS) lymphoma History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases 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. HIV-infected patients Active hepatitis infection Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol Pregnant or lactation Other medical conditions determined by the researchers that may affect the study For T3 should exclude patiens with active autoimmune disease

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

CHOP+selinexor+5-Azacitidine

CHOP+duvelisib+5-Azacitidine

CHOP+chidamide+tislelizumab

Arm Description

Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive 5-Azacitidine ih d-7-d-1 and selinexor 40mg or 60mg in phase I triaI on days d1,d8 while selinexor RP2D po in phase II trial followed by standard CHOP of every 21-day cycle.

Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive 5-Azacitidine ih d-7-d-1 and duvelisib 25mg or 50mg in phase I triaI on days d1-21 while duvelisib RP2D po in phase II trial followed by standard CHOP of every 21-day cycle.

Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive tislelizumab 200mg d1 ivgtt and chidamide 20mg or 30mg po in phase I triaI biw while chidamide RP2D po in phase II trial followed by standard CHOP of every 21-day cycle.

Outcomes

Primary Outcome Measures

complete response rate

Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

Secondary Outcome Measures

Progression-free survival

Progression-free survival was defined as the time from the date of randomization 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

Overall survival was defined as the time from the date of randomization to the date of death from any cause.

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.

Full Information

NCT ID

NCT05675813

First Posted

December 29, 2022

Last Updated

December 29, 2022

Sponsor

Ruijin Hospital

Collaborators

Peking University People's Hospital, Sun Yat-sen University, Tongji Hospital, West China Hospital, Nanfang Hospital, Southern Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05675813

Brief Title

Genotype-guided Treatment in PTCL

Acronym

THEORY

Official Title

T-cell Lymphoma Series：A Genotype-guided Therapy in Newly Diagnosed Patients With Peripheral T-cell Lymphoma （THEORY Study）

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 15, 2023 (Anticipated)

Primary Completion Date

December 15, 2024 (Anticipated)

Study Completion Date

December 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

Collaborators

Peking University People's Hospital, Sun Yat-sen University, Tongji Hospital, West China Hospital, Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP-X2) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with peripheral T-cell lymphoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral T Cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CHOP+selinexor+5-Azacitidine

Arm Type

Experimental

Arm Description

Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive 5-Azacitidine ih d-7-d-1 and selinexor 40mg or 60mg in phase I triaI on days d1,d8 while selinexor RP2D po in phase II trial followed by standard CHOP of every 21-day cycle.

Arm Title

CHOP+duvelisib+5-Azacitidine

Arm Type

Experimental

Arm Description

Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive 5-Azacitidine ih d-7-d-1 and duvelisib 25mg or 50mg in phase I triaI on days d1-21 while duvelisib RP2D po in phase II trial followed by standard CHOP of every 21-day cycle.

Arm Title

CHOP+chidamide+tislelizumab

Arm Type

Experimental

Arm Description

Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive tislelizumab 200mg d1 ivgtt and chidamide 20mg or 30mg po in phase I triaI biw while chidamide RP2D po in phase II trial followed by standard CHOP of every 21-day cycle.

Intervention Type

Drug

Intervention Name(s)

CHOP+selinexor+5-Azacitidine

Intervention Description

Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive 5-Azacitidine ih d-7-d-1 and selinexor 40mg or 60mg in phase I triaI on days d1,d8 while selinexor RP2D po in phase II trial followed by standard CHOP of every 21-day cycle.

Intervention Type

Drug

Intervention Name(s)

CHOP+duvelisib+5-Azacitidine

Intervention Description

Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive 5-Azacitidine ih d-7-d-1 and duvelisib 25mg or 50mg in phase I triaI on days d1-21 while duvelisib RP2D po in phase II trial followed by standard CHOP of every 21-day cycle.

Intervention Type

Drug

Intervention Name(s)

CHOP+chidamide+tislelizumab

Intervention Description

Patients in this arm will receive cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 1, and prednisone 100 mg/day PO on days 1-5 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive tislelizumab 200mg d1 ivgtt and chidamide 20mg or 30mg po in phase I triaI biw while chidamide RP2D po in phase II trial followed by standard CHOP of every 21-day cycle.

Primary Outcome Measure Information:

Title

complete response rate

Description

Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.

Time Frame

End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]

Secondary Outcome Measure Information:

Title

Progression-free survival

Description

Progression-free survival was defined as the time from the date of randomization 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.

Time Frame

Baseline up to data cut-off (up to approximately 2 years)

Title

Overall survival

Description

Overall survival was defined as the time from the date of randomization to the date of death from any cause.

Time Frame

Baseline up to data cut-off (up to approximately 2 years)

Title

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0

Description

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.

Time Frame

From enrollment to study completion, a maximum of 4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Histologically-confirmed Peripheral T-cell lymphoma Availability of archival or freshly collected tumor tissue before study enrollment Evaluable lesion by PET-CT or CT scan Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 Life expectancy greater than or equal to (>/=) 3 months Informed consent Exclusion Criteria: Patients with central nervous system (CNS) lymphoma History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases 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. HIV-infected patients Active hepatitis infection Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol Pregnant or lactation Other medical conditions determined by the researchers that may affect the study For T3 should exclude patiens with active autoimmune disease

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Weili Zhao

Phone

+862164370045

Ext

610707

Email

zwl_trial@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Pengpeng Xu

Phone

+862164370045

Ext

610707

Email

pengpeng_xu@126.com

Genotype-guided Treatment in PTCL (THEORY)

Peripheral T Cell Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial