Refractory Peripheral T-Cell Lymphomas, Relapsed Peripheral T-Cell Lymphomas
Conditions
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 CAOLD Regimen in the treatment of relapsed/refractory peripheral t-cell lymphomas.
Detailed description
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with CAOLD Regimen in relapsed/refractory peripheral t-cell lymphomas.
Interventions
DRUGAzacytidine plus CAOLD regimen
Patients were treated by Azacytidine(75 mg/m2 on days 1-7) plus CAOLD regimen (cyclophosphamide 400mg/m2 qd d1; cytarabine 30mg/m2 qd d1-d4; vindesine 2mg/m2 qd d1; pegaspargase 2500iu/m2 qd d2; dexamethasone 7.5mg/m2 qd d1-d5)
Sponsors
Chinese PLA General Hospital
Navy General Hospital, Beijing
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
Patients must satisfy all following criteria to be enrolled in the study: * Pathologically confirmed angioimmunoblastic T-cell lymphoma according World Health Organization (WHO) classification; * Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF). * Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted; * Patient is willing and able to adhere to the study visit schedule and other protocol requirements; * Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below.) * Meet the following lab criteria: * Absolute Neutrophil Count (ANC) ≥ 1,5 x 10\^9/L (≥ 1 x 10\^9/L if bone marrow (BM) involvement by lymphoma) * Platelet ≥ 75 x 10\^9/L (≥ 50 x 10\^9/L if BM involvement by lymphoma) * Hemoglobin ≥ 8 g/dL. * Anticipated life expectancy at least 3 months
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) | 1 year | ORR was defined as the proportion of patients who achieved CR or PR as their best response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Progression Free Survival (PFS) | 18 months | PFS using local assessment of progressive disease according to Lugano Response Criteria (2014) |
Countries
China
Contacts
Primary ContactLiren Qian, PhD
Outcome results
None listed