Azacytidine Plus Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma

Brief Title

Azacytidine Plus Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma

Official Title

Azacytidine Combined With Chidamide in the Treatment of Relapsed and Refractory Angioimmunoblastic T-cell Lymphoma: a Multicenter Single Arm Phase II Study

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 chidamide in the treatment of
      relapsed/refractory angioimmunoblastic T-cell lymphoma.
    

Detailed Description

      Azacytidine was given subcutaneously at a dose of 75 mg/m2 on days 1-7. Chidamide was an oral
      tablet which was administered 20mg twice weekly. This regimen was repeated every 28 days.
      Treatment was given until disease progression, unacceptable toxicity, or patient/investigator
      discretion.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall Response Rate (ORR)

Secondary Outcome

 progression-free survival (PFS)

Condition

Angioimmunoblastic T-cell Lymphoma

Intervention

Azacitidine

Study Arms / Comparison Groups

 Azacytidine combined with chidamide
Description:  Patients in the experimental arm will received azacytidine plus chidamide treatment. This regimen was repeated every 28 days.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

January 1, 2022

Completion Date

May 1, 2024

Primary Completion Date

January 1, 2024

Eligibility Criteria

        Inclusion Criteria:

          -  Pathologically confirmed angioimmunoblastic T-cell lymphoma according World Health
             Organization (WHO) classification;

          -  Age≥18years;

          -  ECOG≤2;

          -  Patients received at least one systemic treatment previously and achieved no remission
             or relapsed after first-line treatment;

          -  Adequate bone marrow hematopoietic function: ANC>1.5 × 109/L,HGB>90g/L,PLT>80 × 109/L;

          -  Adequate organ function: ALT≤3 times ULN, TBil≤1.5 times ULN, SCr≥50ml/min/m2, cardiac
             function grade 0-2 (NYHA);

        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;
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Wei Zhang, Dr, +86 13521760705, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05179213

Organization ID

PUMCH-NHL-012


Responsible Party

Sponsor

Study Sponsor

Peking Union Medical College Hospital

Collaborators

 Beijing Longfu Hospital

Study Sponsor

Wei Zhang, Dr, Study Director, Peking Union Medical College Hospital


Verification Date

December 2021