Azacytidine Plus CAOLD Regimen in Relapsed/Refractory Angioimmunoblastic T Cell Lymphoma

Study Overview
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Brief Summary
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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 angioimmunoblastic T-cell lymphoma.

Detailed Description
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The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with CAOLD Regimen in relapsed/refractory angioimmunoblastic T-cell lymphoma.

Official Title
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Therapeutic Effect of Chemotherapy Azacytidine Plus CAOLD Regimen on Patients With Relapsed/Refractory Angioimmunoblastic T-cell Lymphoma

Conditions
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Relapsed Angioimmunoblastic T-Cell Lymphoma, Refractory Angioimmunoblastic T-cell Lymphoma

Intervention / Treatment
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* Drug: Azacytidine plus CAOLD regimen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azacytidine plus CAOLD regimen<br>Patients were treated by Azacytidine plus CAOLD regimen | Drug: Azacytidine plus CAOLD regimen<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | ORR was defined as the proportion of patients who achieved CR or PR as their best response | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS was defined as time from diagnosis to death from any cause or the last follow-up | through study completion, an average of 2 year | 
| Progression Free Survival (PFS) | PFS using local assessment of progressive disease according to Lugano Response Criteria (2014) | 18 months |