RecruitingPhase 2NCT05958719

Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma

Evaluation of Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for Reviously Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

37 participants

Start Date

Mar 2, 2023

Study Type

INTERVENTIONAL

Conditions

Peripheral T Cell Lymphoma Epigenetic Repression

Summary

This study is investigating the effectiveness (specifically the objective response rate - ORR) of a new combination therapy called CAMP (chidamide, azacitidine, liposomal mitoxantrone, and prednisone) for previously untreated angioimmunoblastic T-cell lymphoma (AITL). It's a single-arm study comparing CAMP's safety and efficacy to standard treatments. Younger patients (≤70) receive the full CAMP regimen, while older patients receive a modified version (CAMP-light). Patients are assessed via PET-CT after 4 cycles. Responders (CR/PR) receive consolidation therapy and then maintenance chidamide for 2 years. Eligible patients achieving CR after 4 cycles can get a transplant, while those with PR need 2 more cycles first. Patients with stable or progressive disease after 4 cycles are withdrawn. Progression at any time leads to study discontinuation.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of four drugs — chidamide (an anti-cancer pill), azacitidine, liposomal mitoxantrone, and etoposide — as a first-line treatment for a rare type of lymphoma called nodal T-follicular helper (TFH) cell lymphoma. This is a newly diagnosed, untreated patient population. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of nodal T-follicular helper cell lymphoma - You have not previously received any treatment (chemotherapy, radiation, or other anti-cancer therapy) - Your major organ functions (blood counts, liver, kidneys, heart) are within acceptable levels - Your performance status is good (ECOG 0–2) **You may NOT be eligible if...** - You have lymphoma involving the brain or spinal fluid - You are pregnant or breastfeeding - You have HIV - You have had another cancer in the past 5 years (with limited exceptions for treated skin cancers or cervical carcinoma in situ) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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