Azacytidine Plus CAOLD Regimen in Relapsed/Refractory Peripheral T-Cell Lymphomas

Navy General Hospital, Beijing

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Relapsed Peripheral T-Cell Lymphomas

Refractory Peripheral T-Cell Lymphomas

Treatments

Drug: Azacytidine plus CAOLD regimen

Study type

Interventional

Funder types

Other

Identifiers

NCT06176027

NavyGHB-008

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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