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NCT Number: NCT06176027

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Navy General Hospital

Beijing, Beijing Municipality, 100048, China

Location status: Recruiting

Location contact

Liren Qian, M.D.

CONTACT

[email protected]

+861066957676

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azacytidine plus CAOLD regimen

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)

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: 1 year

    ORR was defined as the proportion of patients who achieved CR or PR as their best response

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 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

  2. Progression Free Survival (PFS)

    Time frame: 18 months

    PFS using local assessment of progressive disease according to Lugano Response Criteria (2014)

Study contacts

Contact information is provided by the study sponsor or research team.

Liren Qian, PhD

CONTACT

[email protected]

+861066957676

Sponsors and collaborators

Lead sponsor

Navy General Hospital, Beijing

Other

Collaborators

  • Chinese PLA General Hospital

Registry information

Official study title

Therapeutic Effect of Chemotherapy Azacytidine Plus CAOLD Regimen on Patients With Relapsed/Refractory Peripheral T-Cell Lymphomas

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
Dec 19, 2023
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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