OncoMatch/Clinical Trials/NCT06788756
L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML
Is NCT06788756 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Liposomal Annamycin and Liposomal Annamycin for acute myeloid leukaemia (aml).
Treatment: Liposomal Annamycin · Liposomal Annamycin · Liposomal Annamycin for — This pivotal phase 2/3, multi-center, adaptive design study of L-Annamycin for Injection in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML is divided into two parts, Part A and Part B.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Excluded: FLT3 mutation
Disease stage
Required: Stage REFRACTORY, RELAPSED (ELN 2022)
Has refractory/relapsed AML after having received only one prior line of therapy
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: cytotoxic chemotherapy — first-line
Has refractory/relapsed AML after having received only one prior line of therapy
Cannot have received: mediastinal radiotherapy
Received prior mediastinal radiotherapy
Cannot have received: L-asparaginase (L-asparaginase)
Has received prior treatment with L-asparaginase
Cannot have received: anthracycline
Exception: total cumulative prior anthracycline dose of > 300 mg/m2 (daunorubicin equivalent dose)
Has received a total cumulative prior anthracycline dose of > 300 mg/m2 (daunorubicin equivalent dose)
Cannot have received: investigational therapy
Has received no investigational therapy within 4 weeks prior to the first randomized dose of study drug
Lab requirements
Kidney function
Creatinine clearance ≥60 mL/min (Cockcroft-Gault equation)
Liver function
Total bilirubin ≤2.0 x ULN (≤3.0 x ULN with leukemic involvement or Gilbert Syndrome); AST, ALT, and alkaline phosphatase <3.5 x ULN (≤4.5 x ULN with organ involvement)
Cardiac function
Abnormal LVEF at screening; valvular heart disease; severe, uncontrolled hypertension; uncontrolled cardiac arrhythmias; recent (≤6 months) myocardial infarction; unstable angina; symptomatic congestive heart failure; NYHA class 3 or 4; QT/QTc >480 msec; history of additional risk factors for torsade des pointes; use of concomitant medications that significantly prolong the QT/QTc interval
Has adequate laboratory results at screening including the following: Total bilirubin ≤2.0 times the upper limit of normal (ULN)... Creatinine clearance ≥60 mL/min... Has impaired cardiac function, including any of the following: Abnormal LVEF at screening... etc.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Bioresearch Partners · Miami, Florida
- Atlantic Health · Morristown, New Jersey
- University Hospitals Cleveland Medical Center · Cleveland, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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