Angioimmunoblastic T-cell Lymphoma
Conditions
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.
Interventions
DRUGChidamide
Chidamide 20mg per day administered orally on Day 1, 4, 8, 11 of each 21-day cycle for 6 cycles
DRUGCyclophosphamide
Cyclophosphamide 750 milligrams per square metre (mg/m\^2), administered intravenously (IV) on Day 1 of each 21-day cycle.
DRUGDoxorubicin
Doxorubicin 50 mg/m\^2 IV, administered on Day 1 of each 21-day cycle.
DRUGVincristine
Vincristine 1.4 mg/m\^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.
DRUGPrednisone
Prednisone 60mg/m2 , Maximum 100 mg , (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate | At the end of Cycle 6 (each cycle is 21 days) | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | At the end of Cycle 6 (each cycle is 21 days) | 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 | Baseline up to data cut-off (up to approximately 4 years) | 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 | Baseline up to data cut-off (up to approximately 4 years) | 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. |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | Baseline up to data cut-off (up to approximately 4 years) | 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 | 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) ] | 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. |
| Duration of response | Baseline up to data cut-off (up to approximately 4 years) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Circulating free Deoxyribonucleic Acid (cfDNA) monitoring | Baseline up to data cut-off (up to approximately 4 years) | cfDNA in peripheral blood assessed by local lab |
Countries
China
Outcome results
None listed