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Study Evaluating the Safety and Efficacy of C-CHOP in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma

Primary Purpose

Angioimmunoblastic T-cell Lymphoma

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angioimmunoblastic T-cell Lymphoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Pathologically confirmed angioimmunoblastic T cell lymphoma
  2. Treatment naive
  3. Age > 18 years
  4. Must has measurable lesion in CT or PET-CT prior to treatment
  5. ECOG 0,1,2
  6. Informed consented

Exclusion Criteria:

  1. Has accepted Chemotherapy before
  2. Has accepted autologous Stem cell transplantation before
  3. History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3 years prior to study treatment
  4. Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
  5. Primary CNS lymphoma
  6. LVEF≤50%
  7. Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/L ;Platelet<75*10^9/L; ALT or AST >2*ULN; AKP or bilirubin >1.5*ULN ;Creatinine>1.5*ULN
  8. Other uncontrollable medical condition that may that may interfere the participation of the study
  9. Not able to comply to the protocol for mental or other unknown reasons
  10. Pregnant or lactation
  11. HIV infection
  12. If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.

Sites / Locations

  • Ruijin hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chidamide plus CHOP

Arm Description

Participants received six 21-day cycles of chidamide, combined with six cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy (21-day cycles).

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

Overall response rate
Percentage of participants with response(complete response and partial response) was determined on the basis of investigator assessments according to 2014 Lugano criteria
Progression free survival
Progression-free survival was defined as the time from the date of diagnosis 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 in the overall study population was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event.
Duration of response
time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
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.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants.

Full Information

First Posted
February 19, 2019
Last Updated
April 19, 2022
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03853044
Brief Title
Study Evaluating the Safety and Efficacy of C-CHOP in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma
Official Title
A Phase 2, Open-Label Study to Evaluate the Safety and Efficacy of Chidamide Combined With CHOP(Cyclophosphamide, Doxorubicin, Vincristine, Prednisone ) in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 29, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single-arm, open-label phase 2study of Chidamide in combination with CHOP in the treatment of subjects with untreated angioimmunoblastic T cell lymphoma.
Detailed Description
This open-label, single arm study will evaluate the efficacy and safety of chidamide in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy in previously untreated subjects with angioimmunoblastic T cell lymphoma. Subjects will receive 6 cycles of Chidamide 20mg, day 1,4,8,11, orally (PO) every 21 days, in addition to 6 cycles of CHOP chemotherapy IV every 21 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angioimmunoblastic T-cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chidamide plus CHOP
Arm Type
Experimental
Arm Description
Participants received six 21-day cycles of chidamide, combined with six cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy (21-day cycles).
Intervention Type
Drug
Intervention Name(s)
Chidamide
Intervention Description
Chidamide 20mg per day administered orally on Day 1, 4, 8, 11 of each 21-day cycle for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone 60mg/m2 , Maximum 100 mg , (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 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
At the end of Cycle 6 (each cycle is 21 days)
Secondary Outcome Measure Information:
Title
Overall response rate
Description
Percentage of participants with response(complete response and partial response) was determined on the basis of investigator assessments according to 2014 Lugano criteria
Time Frame
At the end of Cycle 6 (each cycle is 21 days)
Title
Progression free survival
Description
Progression-free survival was defined as the time from the date of diagnosis 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 4 years)
Title
Overall survival
Description
Overall survival in the overall study population was defined as the time from the date of diagnosis to the date of death from any cause. Reported is the percentage of participants with event.
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
Title
Duration of response
Description
time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with PET-CT.
Time Frame
Baseline up to data cut-off (up to approximately 4 years)
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
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
Baseline up to data cut-off (up to approximately 4 years)
Title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Description
The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants.
Time Frame
Baseline (pre-dose [Hour 0] on Cycle1 Day1), Cycle3 Day 1, end of treatment (up to Month 6), every 3 months 1st year, every 6 months 2nd year, and 12 months thereafter up to data cut-off, up to approximately 4 years (cycle length = 21 days) ]
Other Pre-specified Outcome Measures:
Title
Circulating free Deoxyribonucleic Acid (cfDNA) monitoring
Description
cfDNA in peripheral blood assessed by local lab
Time Frame
Baseline up to data cut-off (up to approximately 4 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically confirmed angioimmunoblastic T cell lymphoma 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: Has accepted Chemotherapy before 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 3 years prior to study treatment Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease Primary CNS lymphoma LVEF≤50% Lab at enrollment (Unless caused by lymphoma): Neutrophile<1.5*10^9/L ;Platelet<75*10^9/L; ALT or AST >2*ULN; AKP or bilirubin >1.5*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 Pregnant or lactation HIV infection If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, MD. PhD
Organizational Affiliation
Ruijin Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ruijin hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study Evaluating the Safety and Efficacy of C-CHOP in Untreated Subjects With Angioimmunoblastic T Cell Lymphoma

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