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New treatment option for Relapsed/Refractory Acute Myeloid Leukaemia
Official title Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R AML
ClinicalTrials.gov ID: NCT06621212
What this study is testing
What is mitoxantrone hydrochloride liposome?
mitoxantrone hydrochloride liposome is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed/refractory acute myeloid leukaemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this prospective, multi-center, single-arm, phase 2 study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, standard-dose of cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. The study plan to enroll 72 R/R AML patients who are expected to receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and...
- Age ≥18
- Clinically diagnosed relapsed/refractory AML, excluding acute promyelocytic leukemia.
- Patients who failed after at least 1 courses of initial induction therapy.
- Bone marrow blasts≥5% after CR/CRi, or reappearance of blasts in the blood in at least 2 peripheral blood samples at least one week apart, or...
You likely can't join if
- Previous anti-tumor therapy meets one of the following criteria:
- Prior therapy with mitoxantrone or mitoxantrone liposome;
- Prior therapy with doxorubicin or anthracyclines, and the cumulative dose of doxorubicin \> 360 mg/m\^2 (1 mg doxorubicin was equivalent to 2 mg...
- Have received other anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, Chinese medicines with anti-tumor activity, except...
- people who received strong or moderate CYP3A inducers/inhibitors or P-glycoprotein (P-gp) inhibitors within 7 days before starting study treatment;
- people who are unable to take oral medications or have malabsorption syndrome;
See the full eligibility criteria
- Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
- Age ≥18
- Clinically diagnosed relapsed/refractory AML, excluding acute promyelocytic leukemia.
- Patients who failed after at least 1 courses of initial induction therapy.
- Bone marrow blasts≥5% after CR/CRi, or reappearance of blasts in the blood in at least 2 peripheral blood samples at least one week apart, or leukemia cell infiltration appeared in extramedullary.
- Conversion from MRD negativity to MRD positivity after CR/CRi.
- Physical status score of Eastern Oncology Collaboration Group (ECOG) 0-2.
- Life expectancy \> 3 months.
- AST/ALT≤2.5 ULN (for people with hepatic infiltration≤5 ULN); Total bilirubin≤1.5 ULN (for people with hepatic infiltration≤3 ULN); Serum creatinine≤1.5 ULN.
- Previous anti-tumor therapy meets one of the following criteria:
- Prior therapy with mitoxantrone or mitoxantrone liposome;
- Prior therapy with doxorubicin or anthracyclines, and the cumulative dose of doxorubicin \> 360 mg/m\^2 (1 mg doxorubicin was equivalent to 2 mg daunorubicin or 0.5 mg idarubicin);
- Have received other anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, Chinese medicines with anti-tumor activity, except those that do not affect the how well it works of the study as...
- people who received strong or moderate CYP3A inducers/inhibitors or P-glycoprotein (P-gp) inhibitors within 7 days before starting study treatment;
- people who are unable to take oral medications or have malabsorption syndrome;
- Cardiovascular diseases, including but not limited to:
- QTc interval \>480 ms or long QTc syndrome in screening;
- Complete left bundle branch block, 2 or 3 grade atrioventricular block;
- Requiring treatment of serious and uncontrolled arrhythmia;
- New York Heart Association NYHA≥2;
- Cardiac ejection fraction (EF) was less than 50%;
- Myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other history of arrhythmia or clinically serious pericardial disease that requires treatment within the first 6 months of...
- Central nervous system leukemia;
- Previous or current occurrence of other malignancies (in addition to non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been...
- people are suffering from any other uncontrollable disease (including but not limited to: uncontrolled diabetes and hypertension, and advanced infection);
- HIV infection.
- HBsAg or HBcAb positive, with HBV-DNA≥1x10\^3 copies/mL; or HCV-RNA≥1x10\^3 copies/mL;
- A history of immediate or delayed allergy to similar drug and excipients of the investigate drug.
- Pregnant, lactating female or people who refuse to use effective contraception during the study.
- With a history of severe neurological or psychiatric illness.
- Not suitable for this study as decided by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.