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Chidamide Plus Azacitidine for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma

Primary Purpose

Peripheral T Cell Lymphoma, Epigenetic Repression

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide
Azacitidine
Sponsored by
Institute of Hematology & Blood Diseases Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T Cell Lymphoma

Eligibility Criteria

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

Inclusion Criteria: Subjects must have histological confirmation of nodal T-follicular helper (TFH) cell lymphoma. More than 18 years of age. Proper functioning of the major organs: 1) The absolute value of neutrophils (≥1×10^9/L); 2) platelet count (≥75×10^9/L); 3) Serum total bilirubin ≤ 1.5 times ULN; 4) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN; 5) Serum creatinine (Cr) ≤2 ULN, or glomerular filtration rate ≥40ml/min; Eastern Cooperative Oncology Group (ECOG) Performance status 0-2. LVEF value measured by echocardiography ≥50%. Life expectancy > 3 months. Exclusion Criteria: Patients who have previously received chemotherapy, radiotherapy or other antitumor therapy. Patients with central nervous system involvement by lymphoma. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases. Pregnant or breastfeeding women. Presence of human immunodeficiency virus (HIV) virus infection. Previous history of other malignant tumors, unless the disease has been cured for 5 years or more. The following cured tumors are excluded: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin and related localized non-melanoma skin cancers; Carcinoma in situ of the cervix

Sites / Locations

  • Institute of Hematology & Blood Diseases HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

interim evaluation of CR group

interim evaluation of PR group

Arm Description

Untreated patients with TFH-derived peripheral T-cell lymphoma will be treated with chidamide combined with azacitidine for four cycles. For patients with interim-PET evaluation of CR, consolidation therapy with ASCT or another eight cycles with chidamide combined with azacitidine can be obtained. Subsequently, cidarbenamide monotherapy was given as maintenance therapy for 12 months. Patients with interim evaluation of SD or PD withdrew from this study.

Untreated patients with TFH-derived peripheral T-cell lymphoma will be treated with chidamide combined with azacitidine for four cycles. For patients with interim-PET evaluation of PR, another two cycles of chidamide combined with azacitidine will be continued, followed by the second PET-CT efficacy evaluation, and those who achieve CR receive consolidation therapy with ASCT or another six cycles of chidamide combined with azacitidine. Subsequently, cidarbenamide monotherapy was given as maintenance therapy for 12 months. Patients with second efficacy evaluation of PR or SD or PD withdrew from this study.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification by PET-CT as determined by study investigators.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Secondary Outcome Measures

Progression-Free Survival (PFS)
PFS is defined as the time from the initiation of treatment to the date of disease progression or death from any cause.
Duration of Response (DOR)
DOR is defined for participants who experience complete response after treatment and is the time from the first objective response to disease progression or death from any cause.
Overall Survival (OS)
OS is defined as the time from initiation of treatment to the date of death from any cause.

Full Information

First Posted
July 4, 2023
Last Updated
July 14, 2023
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT05958719
Brief Title
Chidamide Plus Azacitidine for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma
Official Title
Chidamide Plus Azacitidine Epigenetic Repression for the Treatment of Previously Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
March 2, 2026 (Anticipated)
Study Completion Date
March 2, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China

4. Oversight

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

5. Study Description

Brief Summary
Untreated patients with Nodal T-follicular Helper (TFH) Cell Lymphoma will be treated with chidamide combined with azacitidine for four cycles. For patients with interim evaluation of CR, consolidation therapy with ASCT or another eight cycles with chidamide combined with azacitidine can be obtained. For patients with interim evaluation of PR, another two cycles of chidamide combined with azacitidine will be continued, followed by the second efficacy evaluation, and those who achieve CR receive consolidation therapy with ASCT or another six cycles of chidamide combined with azacitidine. Subsequently, chidamide was given as maintenance therapy for 12 months. Patients with SD or PD withdrew from this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T Cell Lymphoma, Epigenetic Repression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
interim evaluation of CR group
Arm Type
Experimental
Arm Description
Untreated patients with TFH-derived peripheral T-cell lymphoma will be treated with chidamide combined with azacitidine for four cycles. For patients with interim-PET evaluation of CR, consolidation therapy with ASCT or another eight cycles with chidamide combined with azacitidine can be obtained. Subsequently, cidarbenamide monotherapy was given as maintenance therapy for 12 months. Patients with interim evaluation of SD or PD withdrew from this study.
Arm Title
interim evaluation of PR group
Arm Type
Experimental
Arm Description
Untreated patients with TFH-derived peripheral T-cell lymphoma will be treated with chidamide combined with azacitidine for four cycles. For patients with interim-PET evaluation of PR, another two cycles of chidamide combined with azacitidine will be continued, followed by the second PET-CT efficacy evaluation, and those who achieve CR receive consolidation therapy with ASCT or another six cycles of chidamide combined with azacitidine. Subsequently, cidarbenamide monotherapy was given as maintenance therapy for 12 months. Patients with second efficacy evaluation of PR or SD or PD withdrew from this study.
Intervention Type
Drug
Intervention Name(s)
Chidamide
Intervention Description
chidamide 30mg biw, p.o, 28 days for a cycle.
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
75mg/m2, continuous i.h. on day 1-7，28 days for a cycle.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification by PET-CT as determined by study investigators.
Time Frame
2 years post initiation of treatment
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
2 years post initiation of treatment
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS is defined as the time from the initiation of treatment to the date of disease progression or death from any cause.
Time Frame
2 years post initiation of treatment
Title
Duration of Response (DOR)
Description
DOR is defined for participants who experience complete response after treatment and is the time from the first objective response to disease progression or death from any cause.
Time Frame
2 years post initiation of treatment
Title
Overall Survival (OS)
Description
OS is defined as the time from initiation of treatment to the date of death from any cause.
Time Frame
2 years post initiation of treatment
Other Pre-specified Outcome Measures:
Title
levels of lymphocyte subsets in blood
Time Frame
2 years post initiation of treatment
Title
levels of cytokines in serum
Time Frame
2 years post initiation of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have histological confirmation of nodal T-follicular helper (TFH) cell lymphoma. More than 18 years of age. Proper functioning of the major organs: 1) The absolute value of neutrophils (≥1×10^9/L); 2) platelet count (≥75×10^9/L); 3) Serum total bilirubin ≤ 1.5 times ULN; 4) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN; 5) Serum creatinine (Cr) ≤2 ULN, or glomerular filtration rate ≥40ml/min; Eastern Cooperative Oncology Group (ECOG) Performance status 0-2. LVEF value measured by echocardiography ≥50%. Life expectancy > 3 months. Exclusion Criteria: Patients who have previously received chemotherapy, radiotherapy or other antitumor therapy. Patients with central nervous system involvement by lymphoma. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases. Pregnant or breastfeeding women. Presence of human immunodeficiency virus (HIV) virus infection. Previous history of other malignant tumors, unless the disease has been cured for 5 years or more. The following cured tumors are excluded: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin and related localized non-melanoma skin cancers; Carcinoma in situ of the cervix
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dehui Zou, Dr.
Phone
86-022-23909282
Email
zoudehui@ihcams.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Huimin Liu, Dr.
Phone
86-022-23909282
Email
liuhuimin@ihcams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dehui Zou, Dr.
Organizational Affiliation
Institute of Hematology & Blood Diseases Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Hematology & Blood Diseases Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dehui Zou, Dr.
Phone
86-022-23909282
Email
zoudehui@ihcams.ac.cn
First Name & Middle Initial & Last Name & Degree
Huimin Liu, Dr.
Phone
86-022-23909282
Email
liuhuimin@ihcams.ac.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Chidamide Plus Azacitidine for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma

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