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

Peripheral T Cell Lymphoma Clinical Trial

Official title:

Chidamide Plus Azacitidine Epigenetic Repression for the Treatment of Previously Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05958719
• Other study ID #: IIT2023003-EC-1
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2, 2023
• Est. completion date: March 2, 2027

Study information

• Verified date: July 2023
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: Dehui Zou, Dr.
• Phone: 86-022-23909282
• Email: zoudehui[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: March 2, 2027
• Est. primary completion date: March 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects must have histological confirmation of nodal T-follicular helper (TFH) cell lymphoma.

2. More than 18 years of age.

3. 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;

4. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.

5. LVEF value measured by echocardiography =50%.

6. Life expectancy > 3 months.

Exclusion Criteria:

1. Patients who have previously received chemotherapy, radiotherapy or other antitumor therapy.

2. Patients with central nervous system involvement by lymphoma.

3. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases.

4. Pregnant or breastfeeding women.

5. Presence of human immunodeficiency virus (HIV) virus infection.

6. Previous history of other malignant tumors, unless the disease has been cured for 5

years or more. The following cured tumors are excluded:

1. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin and related localized non-melanoma skin cancers;

2. Carcinoma in situ of the cervix

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell, Peripheral
• Peripheral T Cell Lymphoma

Intervention

Drug:
• Chidamide
chidamide 30mg biw, p.o, 28 days for a cycle.
• Azacitidine
75mg/m2, continuous i.h. on day 1-7,28 days for a cycle.

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	levels of lymphocyte subsets in blood		2 years post initiation of treatment
Other	levels of cytokines in serum		2 years post initiation of treatment
Primary	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.	2 years post initiation of treatment
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0		2 years post initiation of treatment
Secondary	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.	2 years post initiation of treatment
Secondary	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.	2 years post initiation of treatment
Secondary	Overall Survival (OS)	OS is defined as the time from initiation of treatment to the date of death from any cause.	2 years post initiation of treatment