NCT04480099

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2020

Typical duration for phase_2

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

July 29, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

2.7 years

First QC Date

July 19, 2020

Last Update Submit

June 10, 2023

Conditions

Peripheral T-cell Lymphoma

Keywords

Peripheral T-cell lymphomaTargeted therapy

Outcome Measures

Primary Outcomes (1)

  • Complete response rate

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

    At the end of Cycle 6 (each cycle is 21 days)

Secondary Outcomes (7)

  • Overall response rate

    At the end of Cycle 6 (each cycle is 21 days)

  • Progression free survival

    Baseline up to data cut-off (up to approximately 4 years)

  • Overall survival

    Baseline up to data cut-off (up to approximately 4 years)

  • Duration of response

    Baseline up to data cut-off (up to approximately 4 years)

  • Treatment related mortality

    Baseline up to data cut-off (up to approximately 4 years)

  • +2 more secondary outcomes

Other Outcomes (2)

  • Circulating free Deoxyribonucleic Acid (cfDNA) monitoring

    Baseline up to data cut-off (up to approximately 4 years)

  • Exploratory biomarker analysis

    Baseline up to data cut-off (up to approximately 4 years)

Study Arms (2)

CHOP

ACTIVE COMPARATOR

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

Drug: CHOP

CHOP+X

EXPERIMENTAL

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

Drug: CHOP+X

Interventions

CHOPDRUG

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
CHOP+XDRUG

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

CHOP+X

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

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

Beijing, China

Location

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

Chengdu, China

Location

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

Fuzhou, China

Location

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

Shandong, China

Location

Shanghai Ruijin Hospital

Shanghai, China

Location

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

Wuhan, China

Location

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

Wuhan, China

Location

Related Publications (1)

  • 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.

    PMID: 39175480DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
First Deputy Director，Hematology Department

Study Record Dates

First Submitted

July 19, 2020

First Posted

July 21, 2020

Study Start

July 29, 2020

Primary Completion

April 20, 2023

Study Completion

April 1, 2024

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations

CN(7)