Targeted Drug Combined With CHOP in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

NCT ID: NCT04480099

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-29
• Study Completion Date: 2024-04-30

Brief Summary

This prospective，multi-center，open-label, controlled study will evaluate the efficacy and safety of targeted drug in combination with CHOP in treatment of newly diagnosed peripheral T-cell lymphoma.

Detailed Description

Peripheral T-cell lymphoma (PTCL）is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for ~10%. Patients with PTCL still have poor treatment response and prognosis under conventional CHOP regimen. There is no standard of care for those patients. Targeted drugs are warranted in this group of patients to improve survival. This prospective，multi-center，open-label, controlled study will evaluate the efficacy and safety of targeted drug in combination with CHOP in treatment of newly diagnosed peripheral T-cell lymphoma.

Conditions

Peripheral T-cell Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CHOP

Patients in this arm will receive conventional CHOP regimen for 6 cycles

Group Type: ACTIVE_COMPARATOR

CHOP

Intervention Type: DRUG

Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses

CHOP+X

Patients in this arm will receive targeted drug in combination with conventional CHOP regimen for 6 cycles, based on NGS results

Group Type: EXPERIMENTAL

CHOP+X

Intervention Type: DRUG

X: X(i.e. targeted drug) will decided by NGS results as following. Decitabine 10mg/m2 ivgtt D-5 to-1 if with TP53 gene muation. Azacitadine 100mg/day ivgtt D-7 to -1 if with TET2/KMT2D gene mutation. Chidamide 20mg/day po D1,4,8,11 if with CREBBP/EP300 gene mutation. Lenalidomide 25mg/day po D1-10 if without gene mutation above. X will be added from the second cycle CHOP:Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses

Interventions

CHOP

Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses

Intervention Type: DRUG

CHOP+X

X: X(i.e. targeted drug) will decided by NGS results as following. Decitabine 10mg/m2 ivgtt D-5 to-1 if with TP53 gene muation. Azacitadine 100mg/day ivgtt D-7 to -1 if with TET2/KMT2D gene mutation. Chidamide 20mg/day po D1,4,8,11 if with CREBBP/EP300 gene mutation. Lenalidomide 25mg/day po D1-10 if without gene mutation above. X will be added from the second cycle CHOP:Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Pathologically confirmed peripheral T-cell lymphoma based on 2016 WHO classification with enough tumor sample for NGS
• Treatment naive
• Age ≥ 18 years
• Must has measurable lesion in CT or PET-CT prior to treatment
• ECOG 0,1,2
• Informed consented

Exclusion Criteria

• ALCL,ALK positive, NK/T-cell leukemia, adult T-cell lymphoma/leukemia, T-LGL
• Has accepted localized or systemic anti-lymphoma treatment
• Has accepted autologous Stem cell transplantation before
• History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix prior to study treatment
• Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
• Primary CNS lymphoma
• Left EF≤ 50%
• Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/ L ;Platelet<50*10^9/L; ALT or AST >2*ULN; Creatinine>1.5*ULN
• Other uncontrollable medical condition that may that may interfere the participation of the study
• Not able to comply to the protocol for mental or other unknown reasons
• Patients with mentally disorders or other reasons unable to fully comply with the study protocol
• Pregnant or lactation
• HIV infection
• HBV-DNA or HCV-RNA positive

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Weili

First Deputy Director，Hematology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Hematology, Peking University Third Hospital, Beijing, China

Beijing, , China

Department of Hematology, West China Hospital, Sichuan University, Chengdu, Sichuan, China

Chengdu, , China

Department of Hematology, Fujian Institute of Hematology, Fujian Provincial Key Laboratory on Hematology, Union Hospital, Fujian Institute of Hematology, Fuzhou, China

Fuzhou, , China

Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China

Shandong, , China

Shanghai Ruijin Hospital

Shanghai, , China

Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Wuhan, , China

Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Wuhan, , China

Countries

China

References

Cai MC, Cheng S, Jing HM, Liu Y, Cui GH, Niu T, Shen JZ, Huang L, Wang X, Huang YH, Wang L, Xu PP, Zhao WL. Targeted agents plus CHOP compared with CHOP as the first-line treatment for newly diagnosed patients with peripheral T-cell lymphoma (GUIDANCE-03): an open-label, multicentre phase 2 clinical trial. Lancet Reg Health West Pac. 2024 Jul 29;50:101160. doi: 10.1016/j.lanwpc.2024.101160. eCollection 2024 Sep.

Reference Type: DERIVED

PMID: 39175480 (View on PubMed)

Other Identifiers

RJ-PTCL-1

Identifier Type: -

Identifier Source: org_study_id