To hear about similar clinical trials, please enter your email below
Trial Title:
Chidamide Plus Azacitidine for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma
NCT ID:
NCT05958719
Condition:
Peripheral T Cell Lymphoma
Epigenetic Repression
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell, Peripheral
Azacitidine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chidamide
Description:
chidamide 30mg biw, p.o, 28 days for a cycle.
Arm group label:
interim evaluation of CR group
Arm group label:
interim evaluation of PR group
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
75mg/m2, continuous i.h. on day 1-7，28 days for a cycle.
Arm group label:
interim evaluation of CR group
Arm group label:
interim evaluation of PR group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology & Blood Diseases Hospital
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Dehui Zou, Dr.
Phone:
86-022-23909282
Email:
zoudehui@ihcams.ac.cn
Contact backup:
Last name:
Huimin Liu, Dr.
Phone:
86-022-23909282
Email:
liuhuimin@ihcams.ac.cn
Start date:
March 2, 2023
Completion date:
March 2, 2027
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05958719
