Azacytidine Plus CAOLD Regimen in Relapsed/Refractory Angioimmunoblastic T Cell Lymphoma

Refractory Angioimmunoblastic T-cell Lymphoma Clinical Trial

Official title:

Therapeutic Effect of Chemotherapy Azacytidine Plus CAOLD Regimen on Patients With Relapsed/Refractory Angioimmunoblastic T-cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06176027
• Other study ID #: NavyGHB-008
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 1, 2024
• Est. completion date: September 1, 2030

Study information

• Verified date: January 2024
• Source: Navy General Hospital, Beijing
• Contact: Liren Qian, PhD
• Phone: +861066957676
• Email: qlr2007[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 angioimmunoblastic T-cell lymphoma.

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 angioimmunoblastic T-cell lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: September 1, 2030
• Est. primary completion date: September 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Refractory Angioimmunoblastic T-cell Lymphoma
• Relapsed Angioimmunoblastic T-Cell Lymphoma

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
China	Navy General Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Navy General Hospital, Beijing	Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	ORR was defined as the proportion of patients who achieved CR or PR as their best response	1 year
Secondary	Overall Survival (OS)	OS was defined as time from diagnosis to death from any cause or the last follow-up	through study completion, an average of 2 year
Secondary	Progression Free Survival (PFS)	PFS using local assessment of progressive disease according to Lugano Response Criteria (2014)	18 months