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

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.

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.

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