NCT05958719 Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma
| NCT ID | NCT05958719 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Peripheral T Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 37 participants |
| Start Date | 2023-03-02 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 37 participants in total. It began in 2023-03-02 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Patients with stable or progressive disease after 4 cycles are withdrawn.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 Criteria
Inclusion Criteria: 1. Subjects must have histological confirmation of nodal T-follicular helper (TFH) cell lymphoma. 2. More than 18 years of age. 3. Proper functioning of the major organs: 1) The absolute value of neutrophils (≥1×10\^9/L); 2) platelet count (≥75×10\^9/L); 3) Serum total bilirubin ≤ 1.5 times ULN; 4) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN; 5) Serum creatinine (Cr) ≤2 ULN, or glomerular filtration rate ≥40ml/min; 4. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2. 5. LVEF value measured by echocardiography ≥50%. 6. Life expectancy \> 3 months. Exclusion Criteria: 1. Patients who have previously received chemotherapy, radiotherapy or other antitumor therapy. 2. Patients with central nervous system involvement by lymphoma. 3. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases. 4. Pregnant or breastfeeding women. 5. Presence of human immunodeficiency virus (HIV) virus infection. 6. Previous history of other malignant tumors, unless the disease has been cured for 5 years or more. The following cured tumors are excluded: 1. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin and related localized non-melanoma skin cancers; 2. Carcinoma in situ of the cervix
Contact & Investigator
Dehui Zou, Dr.
PRINCIPAL INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Frequently Asked Questions
Who can join the NCT05958719 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral T Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05958719 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05958719 currently recruiting?
Yes, NCT05958719 is actively recruiting participants. Contact the research team at zoudehui@ihcams.ac.cn for enrollment information.
Where is the NCT05958719 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT05958719 clinical trial?
NCT05958719 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Dehui Zou, Dr. at Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 37 participants.