Azacytidine Plus CAOLD Regimen in Relapsed/Refractory Peripheral T-Cell Lymphomas
Therapeutic Effect of Chemotherapy Azacytidine Plus CAOLD Regimen on Patients With Relapsed/Refractory Peripheral T-Cell Lymphomas
Navy General Hospital, Beijing
52 participants
Oct 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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;
- 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 Criteria3
- 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
Interventions
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)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06176027