Combining azacytidine with CAOLD for treating relapsed T-cell lymphomas

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

This study is testing a new combination of azacytidine and CAOLD to see if it helps people with relapsed T-cell lymphomas feel better and live longer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Navy General Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06176027 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, single-arm phase II study aims to evaluate the safety and efficacy of azacytidine in combination with the CAOLD regimen for patients with relapsed or refractory peripheral T-cell lymphomas. The study will assess key outcomes such as response rate, progression-free survival (PFS), overall survival (OS), and toxicity associated with the treatment. Participants will receive the combined therapy and will be monitored closely for their response to the treatment and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed angioimmunoblastic T-cell lymphoma who have relapsed or refractory disease after at least one line of systemic therapy.

Not a fit: Patients who do not have angioimmunoblastic T-cell lymphoma or those who have not undergone prior systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat peripheral T-cell lymphomas.

How similar studies have performed: While there have been studies exploring treatments for peripheral T-cell lymphomas, the specific combination of azacytidine with the CAOLD regimen is novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Beijing, Beijing Municipality

• Navy General Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Liren Qian, PhD

Conditions Relapsed Peripheral T-Cell Lymphomas; Refractory Peripheral T-Cell Lymphomas