Health TrialsbyHealthPanel

L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML

ConditionAcute Myeloid Leukaemia (AML)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMoleculin Biotech, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has a pathologically confirmed diagnosis of AML per the 2022 International Consensus Classification (ICC) as adopted in the European LeukemiaNet (ELN) 2022 recommendations for the diagnosis and management of AML. The tests and procedures used to establish the diagnosis of AML should be consistent with the ELN's 2022 recommendations

Has refractory/relapsed AML after having received only one prior line of therapy*.

Between 18 and 80 years of age (inclusive) at the time of signing the informed consent form (ICF).

Has received no chemotherapy, radiation, or major surgery within 2 weeks prior to the first randomized dose of study drug or has recovered from the toxic side effects of that therapy. Hydroxyurea to control white blood cell (WBC) count, supportive measures, and prophylaxes as required under the protocol will be allowed. Treatment of opportunistic or other infections with antibiotics, antifungals, and/or antiviral agents, including therapy for meningeal disease (i.e., intrathecal chemotherapy), per institutional standards of care will be allowed during this period, as long as the symptoms of infection have resolved by 1 week prior to the first dose of randomized study drug.

Disqualifiers

Has prior or current diagnosis of acute promyelocytic leukemia (APL) or myelodysplastic syndrome (MDS)/AML

Received prior mediastinal radiotherapy.

Has central nervous system involvement.

Abnormal LVEF at screening [per American College of Cardiology, normal LVEF is 50 to 70%

Trial design

Design model

Factorial

Treatments tested in this trial

  • Placebo in combination with Cytarabine Injection

    Drug

    placebo (0.9% Sodium Chloride Injection, i.e., the diluent for L-Annamycin for Injection) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days.

  • Liposomal Annamycin Injection in combination with Cytarabine Injection

    Drug

    190 mg/m2/day L-Annamycin for Injection for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days.

  • Liposomal Annamycin Injection in combination with Cytarabine Injection

    Drug

    230 mg/m2/day L-Annamycin for Injection for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days.

  • Liposomal Annamycin for Injection in combination with Cytarabine Injection.

    Drug

    optimal dosage regimen (as determined in Part A) of L Annamycin for Injection (190 mg/m2/day or 230 mg/m2/day) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days (i.e., the same as Treatment Arm 2 or 3, respectively, of Part A).

Treatment groups

312 Participants
are divided into 5 treatment groups
Group A: Part A / Treatment Arm 1Placebo comparator 1 intervention
Group B: Part A / Treatment Arm 2Active comparator 1 intervention
Group C: Part A / Treatment Arm 3Active comparator 1 intervention
Group D: Part B / Treatment Arm 1Placebo comparator 1 intervention
Group E: Part B / Treatment Arm XActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part A -Determination of Optimal Dosage Regimen

1\. To identify the optimal dosage regimen of L Annamycin for Injection (190 versus 230 mg/m2/day) in combination with Cytarabine Injection (2.0 g/m2/day) as second line therapy for remission induction in adult subjects with refractory/relapsed acute myeloid leukemia (AML) as measured by rate of complete remission (CR) after one treatment cycle.

Time frame
From initiation of the first randomized treatment cycle until the first post treatment bone marrow assessment, assessed up to Day 49
2

Part B - Expansion at Optimal Dosage Regimen

To confirm the superior efficacy of the optimal dosage regimen of L-Annamycin for Injection in combination with Cytarabine Injection (determined in Part A) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML as measured by rate of CR after one treatment cycle

Time frame
From initiation of the first randomized treatment cycle until the first post treatment bone marrow assessment, assessed up to Day 49

Secondary outcomes

1

Part A -Comparison of Efficacy as Measured by Overall Survival (OS)

To compare the efficacy of two dose levels of L-Annamycin for Injection (190 versus 230 mg/m2/day) in combination with Cytarabine Injection (2.0 g/m2/day) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML as measured by overall survival (OS)

Time frame
From date of randomization to treatment (Day 1) to the date of death from any cause, assessed up to 2 years after the first dose of randomized study drug
2

Part B - Confirmation of Efficacy of the Optimal Dosage Regimen as Measured by Overall Survival (OS)

To confirm the efficacy of the optimal dosage regimen of L-Annamycin for Injection in combination with Cytarabine Injection (determined in Part A) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML as measured by OS;

Time frame
From date of randomization to treatment (Day 1) to the date of death from any cause, assessed up to 2 years after the first dose of randomized study drug

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Moleculin Biotech, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now