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Annamycin

Clinical trials are studying Annamycin in people with cancer, including acute myeloid leukemia and metastatic soft-tissue sarcomas. These studies look at safety, tolerability, dose selection, and early signs of benefit in adults with relapsed, refractory, or previously treated disease.

Table of contents

Overview of the studies

The source data includes three interventional trials of Annamycin, also called liposomal Annamycin or L-Annamycin in the trial titles and summaries.[1][2][3] These studies are in adults with cancer and focus on two main diseases: acute myeloid leukemia and metastatic soft-tissue sarcomas.[1][2][3]

The trials are designed to learn about safety, tolerability, dose selection, and early signs of benefit.[1][2][3] Two studies use Annamycin with cytarabine, which is another cancer drug named in the source data, and one study tests liposomal Annamycin alone in sarcoma.[1][2][3]

Studies in acute myeloid leukemia

Two trials in the source data study acute myeloid leukemia (AML).[2][3] One is a Phase 2/3 multi-center study in adults with refractory or relapsed AML, meaning the disease did not respond to treatment or came back after treatment.[2] The other is a Phase 1 study that evaluates safety, efficacy, and tolerability of liposomal Annamycin with cytarabine in patients with AML.[3]

The larger AML study compares L-Annamycin plus cytarabine with placebo plus cytarabine as second-line therapy, which means treatment given after the first treatment did not work well enough.[2] Its Part A looks for the best dose regimen, and Part B tests whether the chosen dose works better than placebo when both are given with cytarabine.[2]

The Phase 1 AML study also includes patients who are refractory to or relapsed after induction therapy, and the brief summary says it also considers first-line therapy in the source data.[3] This trial aims to find the maximum tolerated dose and the Recommended Phase 2 Dose, which are study terms for choosing a dose that is workable and can be tested further.[3]

Study in metastatic soft-tissue sarcoma

The sarcoma trial is a Phase 1b/2 study in patients with metastatic soft-tissue sarcomas after failure of at least one systemic therapy.[1] Systemic therapy means treatment that travels through the body, such as treatment given by vein or by mouth, although the source data does not list all prior treatments.[1]

This study tests weekly liposomal Annamycin as monotherapy, which means it is given by itself rather than with another anticancer drug.[1] The Phase Ib part is designed to establish safety and tolerability and to determine the Recommended Phase 2 Dose.[1] The Phase II part measures 3-month progression-free survival, a way to see whether the cancer stays from getting worse for at least three months.[1]

What the trials measure

The main outcomes in these studies are different, but they all help researchers judge whether the treatment is promising.[1][2][3] In the sarcoma study, the key outcomes are safety, tolerability, dose choice, and 3-month progression-free survival.[1] In the AML studies, the trials measure complete remission, dose selection, and in one study whether the patient may be eligible for hematopoietic stem cell transplantation.[2][3]

The AML Phase 1 study gives a detailed definition of complete remission in the source data: normal bone marrow appearance with fewer than 5% blasts, plus recovery of blood counts.[3] It also defines complete remission with incomplete recovery as CR with incomplete recovery of platelets and/or neutrophils, and partial response as a 50% or greater decrease in marrow blasts.[3]

The Phase 2/3 AML study uses the rate of CR after one treatment cycle as its main outcome, measured about 35 days plus or minus 14 days after treatment starts.[2] This kind of endpoint helps show how many people respond after the first cycle of treatment.[2]

Who may join these trials

The source data shows that the trials are for adult subjects with specific cancers.[2][3] The AML studies include adults with refractory or relapsed AML, while the sarcoma study includes patients with metastatic soft-tissue sarcomas after at least one prior systemic therapy.[1][2][3]

These are not general cancer studies for all patients. Each trial focuses on a specific disease group and treatment history, so people need to match the study rules listed in the trial data.[1][2][3]

Trial phases and study size

The trials cover early and later research stages.[1][2][3] The sarcoma study is Phase 1b/2 with 30 planned participants, the Phase 1 AML study has 24 participants, and the Phase 2/3 AML study plans 312 participants.[1][2][3]

The source data also lists the Phase 2/3 AML study as Phase 4 in the phase field, so the trial record contains a phase label that does not fully match the title.[2] In patient-friendly terms, this means the study record should be read carefully because different parts of the source data do not use the same phase label.[2]

Important terms explained

Liposomal means the drug is placed in a tiny fat-like carrier, which is how the trial names describe Annamycin in these studies.[1][2][3] Monotherapy means one drug is used by itself.[1]

Second-line therapy means treatment used after the first treatment does not work well enough or the disease returns.[2] Stem cell transplantation is a treatment approach mentioned in the Phase 1 AML study as an eligibility outcome, meaning the study checks whether a subject is fit enough for that next step of care.[3]

Interventional means the researchers give a treatment and then measure the results.[1][2][3] Authorised and completed are study status labels in the source data that show whether a trial is open for use or already finished.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
2024-517678-12-00 Phase 1b/2 Metastatic soft-tissue sarcomas after failure of at least one systemic therapy Completed 30
2024-518359-47-00 Phase 2/3 (listed as Phase 4 in source data) Acute myeloid leukemia Authorised 312
2024-516388-10-00 Phase 1 Acute myeloid leukemia Completed 24

FAQ

  • What conditions are being studied in Annamycin trials? The trials in the source data study acute myeloid leukemia and metastatic soft-tissue sarcomas. Some studies focus on adults whose disease has come back, has not responded to treatment, or has already been treated before.
  • Who may be able to join these trials? The trials are for adults with specific cancers. One study includes patients with metastatic soft-tissue sarcomas after at least one prior systemic therapy, and the leukemia studies include adults with relapsed or refractory AML.
  • What phases are the Annamycin studies in? The source data includes Phase 1, Phase 1b/2, and Phase 2/3 studies. One AML study is listed as Phase 4 in the source data, even though its title says phase 2/3.
  • What are the trials trying to measure? The studies measure safety, tolerability, dose-finding, complete remission, progression-free survival, and whether a patient may be eligible for stem cell transplantation. These are ways to see if treatment may help and how well it is tolerated.
  • Is Annamycin being studied alone or with other drugs? It is being studied both alone and in combination with cytarabine. In the soft-tissue sarcoma study, liposomal Annamycin is given as monotherapy, while the AML studies use it with cytarabine or compare it with placebo plus cytarabine.

Ongoing Clinical Trials on Annamycin

  • Study of L-Annamycin and Cytarabine for Adults with Refractory or Relapsed Acute Myeloid Leukemia

    Recruiting

    1 1 1
    Investigated drugs:
    Belgium Czechia France Germany Italy Lithuania +3

  • Study of L-Annamycin Treatment for Patients with Previously Treated Metastatic Soft Tissue Sarcoma

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Study of liposomal annamycin and cytarabine combination for patients with acute myeloid leukemia (AML) who are newly diagnosed or have not responded to previous treatment

    Not recruiting

    1 1 1
    Investigated drugs:
    Italy Poland

Glossary

  • Acute myeloid leukemia (AML): A fast-growing cancer of the blood and bone marrow. The studies in the source data include adults with AML that is relapsed or refractory.
  • Relapsed: A disease that came back after treatment had helped for a while.
  • Refractory: A disease that does not respond well to treatment.
  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • Soft-tissue sarcoma: A cancer that starts in soft tissues such as muscle, fat, or connective tissue.
  • Interventional study: A clinical trial where researchers give a treatment and then measure what happens.
  • Phase 1: An early study phase that mainly checks safety, tolerability, and dose.
  • Phase 2/3: Later study phases that look more closely at whether a treatment works and how safe it is in more people.
  • Complete remission (CR): A strong treatment response in which signs of leukemia are not seen in the bone marrow by the study definition.
  • Progression-free survival (PFS): The length of time during and after treatment that the cancer does not get worse.
  • Maximum tolerated dose (MTD): The highest dose that people can take without side effects becoming too severe in the study.
  • Recommended Phase 2 Dose (RP2D): The dose researchers choose to move forward with in later trials after reviewing safety and early results.

References

  1. https://clinicaltrials.gov/study/2024-517678-12-00
  2. https://clinicaltrials.gov/study/2024-518359-47-00
  3. https://clinicaltrials.gov/study/2024-516388-10-00