Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) … (NCT05958719) | Clinical Trial Compass
RecruitingPhase 2
Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma
China37 participantsStarted 2023-03-02
Plain-language 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 Patients with stable or progressive disease after 4 cycles are withdrawn.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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects must have histological confirmation of nodal T-follicular helper (TFH) cell lymphoma.
✓. More than 18 years of age.
✓. 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;
✓. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
✓. LVEF value measured by echocardiography ≥50%.
✓. Life expectancy \> 3 months.
Exclusion criteria
✕. Patients who have previously received chemotherapy, radiotherapy or other antitumor therapy.
✕. Patients with central nervous system involvement by lymphoma.
✕. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: 2 years post initiation of treatment
2
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Timeframe: 2 years post initiation of treatment
Trial details
NCT IDNCT05958719
SponsorInstitute of Hematology & Blood Diseases Hospital, China