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

Phase 1

Recruiting

• Conditions: Relapsed Peripheral T-Cell Lymphomas; Refractory Peripheral T-Cell Lymphomas
• Interventions: Drug: Azacytidine plus CAOLD regimen

• Registration Number: NCT06176027
• Lead Sponsor: Navy General Hospital, Beijing

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-08-05
• Study First Submitted QC: 2023-12-18
• Study First Posted: 2023-12-19
• Status Verified: 2024-10
• Study Start: 2024-10-01
• Last Update Submitted: 2024-10-26
• Last Update Posted: 2024-10-29
• Primary Completion: 2028-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Azacytidine plus CAOLD regimen	Azacytidine plus CAOLD regimen	Patients were treated by Azacytidine plus CAOLD regimen

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	1 year	ORR was defined as the proportion of patients who achieved CR or PR as their best response

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Navy General Hospital; 🇨🇳 Beijing, Beijing, China