Clinical Study of Mitoxantrone Liposome and Azacitidine in the Treatment of R/R AITL (NCT06224842) | Clinical Trial Compass
UnknownPhase 1/2
Clinical Study of Mitoxantrone Liposome and Azacitidine in the Treatment of R/R AITL
China30 participantsStarted 2023-12-12
Plain-language summary
This study is an open-label, single-arm Phase Ib/II clinical trial designed to evaluate the safety and efficacy of the combination therapy with mitoxantrone liposome and azacitidine in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma(R/R AITL). The study includes two parts: a dose escalation phase and a dose expansion phase, each comprising screening, treatment, and follow-up periods. In the dose escalation phase, the mitoxantrone liposome injection will start at a dose of 16 mg/m\^2 on day1, combined with subcutaneous injection of azacitidine at a dose of 75 mg/m\^2 on days 1-7, with each cycle lasting 4 weeks (28 days). Three predetermined dose groups for mitoxantrone liposome are 16, 18, and 20 mg/m\^2. In the dose expansion phase, 10-20 cases will be included with the mitoxantrone liposome injection at the recommended phase II dose (RP2D) based on the results of the dose escalation phase. After the treatment period, safety and survival information will be collected during the follow-up period. This study aims to comprehensively evaluate the safety and efficacy of mitoxantrone liposome in combination with azacitidine for the treatment of R/R AITL, exploring a combination therapy that offers higher survival benefits with limited adverse reactions and providing new therapeutic approaches for R/R AITL.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. neutrophil count ≥ 1.5 x 10\^9/L, it can be relaxed to ≥ 1.0 x 10\^9 /L in patients with bone marrow involvement;
✓. hemoglobin ≥ 90 g/L(without red blood cell transfusion within 14 days), it can be relaxed to ≥ 75 g/L in patients with bone marrow involvement;
✓. platelet count ≥ 75 x 10\^9 /L, it can be relaxed to ≥ 50 x 10\^9 /L in patients with bone marrow involvement;
✓. Total bilirubin ≤ 1.5 times the upper limit of normal value (≤ 3 times the upper limit of normal value for patients with liver invasion);
✓. AST and ALT ≤ 2.5 times the upper limit of normal values ,≤ 5 times the upper limit of normal values for patients with liver invasion;
✓. Serum creatinine ≤ 1.5 times the upper limit of normal value; 8.Qualified patients of reproductive capability (both males and females) must agree to use a reliable contraceptive method with their partners during the trial and for at least 7 months after the last dose of medication. Female patients of childbearing age must have a negative blood pregnancy test within 7 days prior to enrollment.
Exclusion criteria
✕
What they're measuring
1
Adverse events
Timeframe: Through study completion, an average of 2 year.
. Patients previously treated withMitoxantrone liposome in combination with Azacitidine (patients who have received either of the treatments, or those who have received both treatments sequentially, are eligible).
✕. Previous treatment with adriamycin or other anthracyclines, with a total cumulative dose of adriamycin ≥ 350 mg/m2 (conversion for other anthracycline-type drugs: 1 mg of daunorubicin/pirarubicin/epirubicin is equivalent to 0.5 mg of adriamycin, and 1 mg of idarubicin is equivalent to 2 mg of anthracycline).
✕. Receipt of cytotoxic chemotherapy, radiotherapy, targeted therapy within 4 weeks, immunomodulators (thalidomide, lenalidomide) within 3 weeks, or hormonal or herbal therapy for lymphoma within 2 weeks before the first dose of the investigational drug.
✕. Participation in other clinical trials and use of investigational drug treatment within 4 weeks before the first dose of the investigational drug.
✕. History of allogeneic hematopoietic stem cell transplantation or autologous hematopoietic stem cell transplantation within the past 6 months.
✕. Unresolved toxic reactions from prior anti-tumor therapy with toxicity persisting at \> Grade 1, excluding alopecia and pigmentation.
✕. Impaired cardiac function or significant cardiac diseases, including but not limited to:
✕. Occurrence of myocardial infarction, congestive heart failure, or viral myocarditis within the past 6 months before screening;