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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2030-09-01

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 peripheral t-cell lymphomas.

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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 peripheral t-cell lymphomas.

Conditions

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Relapsed Peripheral T-Cell Lymphomas Refractory Peripheral T-Cell Lymphomas

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azacytidine plus CAOLD regimen

Patients were treated by Azacytidine plus CAOLD regimen

Group Type EXPERIMENTAL

Azacytidine plus CAOLD regimen

Intervention Type DRUG

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)

Interventions

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Azacytidine 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)

Intervention Type DRUG

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;
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No