Angioimmunoblastic T-cell Lymphoma
Conditions
Keywords
Angioimmunoblastic T-cell Lymphoma, Azacytidine, Chidamide
Brief summary
This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with chidamide in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma.
Detailed description
Azacytidine was given subcutaneously at a dose of 75 mg/m2 on days 1-7. Chidamide was an oral tablet which was administered 20mg twice weekly. This regimen was repeated every 28 days. Treatment was given until disease progression, unacceptable toxicity, or patient/investigator discretion.
Interventions
DRUGAzacitidine
75 mg/m2 subcutaneously on days 1-7
DRUGChidamide
20mg orally per week continuously
Sponsors
Beijing Longfu Hospital
Peking Union Medical College 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
* Pathologically confirmed angioimmunoblastic T-cell lymphoma according World Health Organization (WHO) classification; * Age≥18years; * ECOG≤2; * Patients received at least one systemic treatment previously and achieved no remission or relapsed after first-line treatment; * Adequate bone marrow hematopoietic function: ANC\>1.5 × 109/L，HGB\>90g/L，PLT\>80 × 109/L; * Adequate organ function: ALT≤3 times ULN, TBil≤1.5 times ULN, SCr≥50ml/min/m2, cardiac function grade 0-2 (NYHA);
Exclusion criteria
* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment; * Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy; * Pregnant or lactating women;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | 1year | ORR was defined as the proportion of patients who achieved CR or PR as their best response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival (PFS) | 1 year | PFS was defined as time from diagnosis to the date of disease progression or death from any cause or the last follow-up. |
| Duration of response (DOR) | through study completion, an average of 1 year | DOR was defined as the time from the first occurrence of CR or PR to the first diagnosis of PD or relapse. |
| overall survival (OS) | through study completion, an average of 2 year | OS was defined as time from diagnosis to death from any cause or the last follow-up. |
| Adverse Events | During the whole treatment | Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 |
Countries
China
Contacts
Primary ContactChong Wei, Dr
Outcome results
None listed