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Amsacrine

Clinical trials investigating Amsacrine are studying how it is used in treatment plans for certain blood cancers, especially before stem cell transplantation and in relapsed or refractory acute myeloid leukemia. These trials look at safety, treatment benefit, and how well patients do in different study groups.

Table of Contents

Clinical trials overview

The trial data includes two interventional studies that investigate Amsacrine as part of treatment plans for blood cancers.[1][2] One study is in patients preparing for allogeneic blood stem cell transplantation, and the other is in patients with relapsed or refractory acute myeloid leukemia (AML).[1][2]

These studies are not simple drug-only tests. They examine Amsacrine inside larger treatment regimens, which means it is given together with other medicines as part of a planned cancer treatment strategy.[1][2]

Phase 1 transplant study in high-risk blood cancers

NCT05807932 is a Phase 1 study in patients with myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or secondary AML before stem cell transplantation.[1] The study is authorised and plans to enroll 38 patients.[1]

This trial studies whether adding Venetoclax to a conditioning regimen that includes Fludarabine, Amsacrine, Ara-C, and Treosulfan is safe in the transplant setting.[1] The brief summary says the study aims to find the maximum tolerated dose, which means the highest dose that can be given without causing unacceptable harm.[1]

The treatment plan also includes other medicines such as tacrolimus, mycophenolic acid, antithymocyte immunoglobulin, pegfilgrastim, filgrastim, rasburicase, febuxostat, allopurinol, and the study drug Venetoclax.[1] In this trial, Amsacrine is part of the sequential conditioning approach used before allogeneic blood stem cell transplantation.[1]

Phase 3 study in relapsed or refractory AML

2024-514517-35-00 is a Phase 3 randomized pragmatic clinical trial in acute myeloid leukemia.[2] The study is authorised and plans to enroll 267 patients.[2]

This study is for people with relapsed or refractory AML, meaning the leukemia has come back or has not responded well to treatment.[2] The brief summary says the trial is designed to compare low-intensity therapy with high-intensity therapy and measure the clinical benefit.[2]

Amsacrine is one of several treatment options listed in the intervention set, along with drugs such as daunorubicin, azacitidine, cytarabine, decitabine, fludarabine, etoposide, gilteritinib, idarubicin, venetoclax, mitoxantrone, ivosidenib, cladribine, and gemtuzumab ozogamicin.[2]

What the trials measure

The main outcome in the Phase 1 transplant study is safety, including the highest level of organ toxicity for each organ system and the number of serious adverse events, or AEs, of grade III or higher until day +30 after transplantation.[1] Grade III or higher means a more serious level of side effect or harm, based on the study’s toxicity criteria.[1]

The main outcome in the Phase 3 AML study is event-free survival, which is the time from randomization until treatment failure, hematologic relapse from CR/CRh/Cri, or death from any cause, whichever happens first.[2] In simple terms, this tells researchers how long patients stay free from major treatment failure or disease return.[2]

Who can participate

The first study targets patients with MDS, CMML, or secondary AML who are going through allogeneic blood stem cell transplantation.[1] The second study targets patients with acute myeloid leukemia, especially those with relapsed or refractory disease.[2]

The trial data does not give full eligibility rules, so the exact participation criteria are not fully listed here.[1][2] What is clear is that both studies focus on people with serious blood cancers and use Amsacrine within broader treatment plans.[1][2]

What to know about these studies

These trials show that researchers are studying Amsacrine in two different settings: before transplant in high-risk blood cancers and in relapsed or refractory AML.[1][2] The goals are to learn whether the treatment plans are safe and whether they improve patient outcomes.[1][2]

Because the studies are early- to later-phase clinical trials, they help build evidence about how Amsacrine may be used in complex leukemia treatment regimens.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT05807932 Phase 1 MDS, CMML, or secondary AML before allogeneic blood stem cell transplantation Authorised 38
2024-514517-35-00 Phase 3 Relapsed or refractory acute myeloid leukemia Authorised 267

FAQ

  • What clinical trials are studying Amsacrine? The trial data includes one Phase 1 study in patients with MDS, CMML, or secondary AML before stem cell transplantation, and one Phase 3 study in relapsed or refractory AML. Both trials are testing Amsacrine as part of a treatment plan.
  • Who may take part in these trials? The target groups are adults with myelodysplastic syndrome, chronic myelomonocytic leukemia, secondary acute myeloid leukemia, or acute myeloid leukemia that has come back or did not respond well to treatment. The exact entry rules are set by each study.
  • What is being measured in the Amsacrine trials? One trial measures safety, including organ toxicity and serious side effects up to day 30 after transplant. The other trial measures event-free survival, which means the time until treatment failure, relapse, or death.
  • What phases are the Amsacrine trials? One study is Phase 1, which usually looks first at safety and the best dose or treatment plan. The other is Phase 3, which compares treatment approaches in a larger group of patients.
  • Why is Amsacrine being used in these studies? In the trial data, Amsacrine is part of a larger treatment combination. The studies are not only about Amsacrine alone, but about how it fits into treatment plans for leukemia and transplant care.

Ongoing Clinical Trials on Amsacrine

  • Study on the Effectiveness of Gilteritinib and Drug Combination for Patients with Relapsed or Refractory Acute Myeloid Leukemia

    Recruiting

    1 1 1 1
    Investigated drugs:
    Czechia Germany Italy Lithuania Portugal Romania +1

  • Study on the Safety and Effectiveness of Venetoclax with Fludarabine, Amsacrine, and Cytarabine for Patients with MDS, CMML, or Secondary AML Undergoing Stem Cell Transplantation

    Recruiting

    1 1 1
    Investigated drugs:
    Germany

Glossary

  • Acute myeloid leukemia (AML): A fast-growing cancer of the blood and bone marrow. It can return after treatment or fail to respond, which is called relapsed or refractory AML.
  • Relapsed: A disease that has come back after a period of improvement.
  • Refractory: A disease that does not respond well to treatment.
  • Myelodysplastic syndrome (MDS): A group of bone marrow disorders where blood cells do not form normally.
  • Chronic myelomonocytic leukemia (CMML): A blood cancer that has features of both a myelodysplastic syndrome and a leukemia.
  • Secondary acute myeloid leukemia (sAML): AML that develops after another blood disorder or after prior treatment.
  • Allogeneic blood stem cell transplantation: A transplant using stem cells from another person. It is used to replace diseased bone marrow with healthy stem cells.
  • Conditioning regimen: Treatment given before a stem cell transplant to prepare the body and help the new cells take hold.
  • Phase 1: An early clinical trial phase that mainly checks safety and may help find the best treatment plan.
  • Phase 3: A later trial phase that studies treatment benefit in a larger group of patients.
  • Event-free survival: The length of time after randomization before the disease gets worse, returns, treatment fails, or the patient dies.
  • Organ toxicity: Harm to an organ, such as the liver, kidneys, or heart, caused by treatment.

References