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 (Jun 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
Treatments studied
Other
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)
Demographics
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 →Frequently asked questions
Is NCT06788756 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior mediastinal radiotherapy, L-asparaginase, anthracycline disqualifies patients from enrollment.
Are patients with FLT3 alterations eligible?
No. FLT3 mutation is an exclusion criterion.
What disease stage is eligible?
Stage REFRACTORY or RELAPSED is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages