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 (Sep 2026). This Phase 2/3 trial studies multiple treatments including Liposomal Annamycin and Liposomal Annamycin for for acute myeloid leukaemia (aml).
Treatment: 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: systemic therapy for AML — first-line AML
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
Has received prior treatment with L-asparaginase
Cannot have received: anthracycline
Exception: total cumulative prior anthracycline dose ≤ 300 mg/m2 (daunorubicin equivalent dose)
Has received a total cumulative prior anthracycline dose of > 300 mg/m2 (daunorubicin equivalent dose)
Lab requirements
Kidney function
Creatinine clearance ≥60 mL/min (Cockcroft-Gault equation)
Liver function
Total bilirubin ≤2.0x ULN (≤3.0x ULN with leukemic involvement or Gilbert Syndrome); AST, ALT, and alkaline phosphatase <3.5x ULN (≤4.5x ULN with organ involvement)
Cardiac function
No abnormal LVEF, valvular heart disease, severe/uncontrolled hypertension, uncontrolled arrhythmias, recent MI (≤6 months), unstable angina, symptomatic CHF, NYHA class 3 or 4, QTc >480 msec, history of risk factors for torsade de pointes, or use of TdP-risk medications unless PI deems safe with monitoring
Has adequate laboratory results at screening including: Total bilirubin ≤2.0x ULN (≤3.0x ULN with leukemic involvement or Gilbert Syndrome); AST, ALT, and alkaline phosphatase <3.5x ULN (≤4.5x ULN with organ involvement); Creatinine clearance ≥60 mL/min. Cardiac exclusion criteria as listed.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Bioresearch Partners · Miami, Florida
- Augusta University - Georgia Cancer Center · Augusta, Georgia
- University of Nebraska Medical Center · Omaha, Nebraska
- 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