RecruitingRare disease

Study on Mocravimod for Adults with Acute Myeloid Leukemia Undergoing Stem Cell Transplant

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness and safety of a treatment for Acute Myeloid Leukemia (AML), a type of cancer that affects the blood and bone marrow. The treatment being tested is called Mocravimod (KRP203), which is taken in the form of capsules. The study involves patients with AML who are undergoing a procedure known as allogeneic hematopoietic cell transplantation (HCT), which is a type of stem cell transplant that uses cells from a donor to help restore the patient's bone marrow.

The purpose of the study is to compare the effects of Mocravimod with a placebo, which is a substance with no active medication. Participants in the study will be randomly assigned to receive either Mocravimod or the placebo. The study will monitor the participants over a period to assess how well the treatment works in preventing the return of cancer and improving survival rates. The study will also look at the treatment's impact on conditions like Graft-versus-Host Disease (GvHD), which can occur after a transplant when the donor's cells attack the recipient's body.

Throughout the study, participants will receive regular check-ups and monitoring to ensure their safety and to gather data on the treatment's effectiveness. The study aims to provide valuable information on whether Mocravimod can be a beneficial addition to the treatment plan for patients with AML undergoing HCT.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of acute myeloid leukemia (AML), and performance status.
Participants must have a life expectancy of at least 6 months and be planning to undergo hematopoietic cell transplantation (HCT).
Step 2
Randomization and initial treatment
Participants are randomly assigned to receive either the study medication, mocravimod, or a placebo.
The medication is administered in the form of hard capsules taken orally.
Step 3
Medication administration
The dosage and frequency of mocravimod are determined by the study protocol, which aims to evaluate its efficacy and safety as an adjunctive and maintenance treatment.
Participants continue taking the medication throughout the study duration, which is estimated to end by April 2027.
Step 4
Monitoring and assessments
Regular monitoring is conducted to assess the participant's health status, focusing on relapse-free survival and overall survival.
Additional assessments include evaluating the absence of severe graft-versus-host disease (GvHD) and other related health outcomes.
Step 5
Completion of the study
The study concludes with a final evaluation of the participant's health outcomes compared to the placebo group.
The primary goal is to determine the sustained efficacy of mocravimod in improving survival rates and reducing relapse.

Who can join the trial?

6 criteria

Patients must have a diagnosis of **AML** (Acute Myeloid Leukemia), but not acute promyelocytic leukemia, according to the **World Health Organization (WHO)** 2022 classification. This includes therapy-related AML with specific gene mutations.
Patients should have a high or intermediate risk according to the **European LeukemiaNet (ELN)**, or be in **CR1** (first complete remission) or any risk in **CR2** (second complete remission). **CRi** (complete remission with incomplete count recovery) is also acceptable. Complete remission means less than 5% of certain cells in the bone marrow, no abnormal cells in the blood, no disease outside the bone marrow, a certain level of white blood cells, and a certain level of platelets. **CRi** means meeting all complete remission criteria except for low white blood cells or low platelets.
Patients should plan to use a related or unrelated donor with no more than one antigen mismatch, or plan to use a **haploidentical donor** (a donor who is a half match).
Patients must have a life expectancy of at least 6 months at the time of screening.
Patients should have an **ECOG performance status** of 0 or 1, which means they are fully active or have some symptoms but do not need to rest during the day.
Patients must be male or female, aged between 18 and 75 years.

Who cannot join the trial?

5 criteria

Patients who are not receiving **HCT** (Hematopoietic Cell Transplantation), which is a procedure to replace damaged or destroyed bone marrow with healthy bone marrow stem cells.
Patients who are not in need of **adjunctive** (additional) or maintenance treatment related to HCT.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not considered part of the vulnerable population selected for the study.

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Verified sites

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Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Responsive
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland

Trial locations

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Investigated drugs

Mocravimod is being studied as an additional treatment for adults with acute myeloid leukemia (AML) who are undergoing a type of stem cell transplant called allogeneic hematopoietic cell transplantation (HCT). The goal is to see if mocravimod can help improve the outcomes of the transplant by supporting the patient's recovery and reducing the risk of leukemia returning.

Mocravimod

What is already known about the treatment

Mocravimod – Mocravimod is administered orally and is currently being studied in clinical trials as an adjunctive and maintenance treatment for patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (HCT). It is in the phase III stage of clinical trials, where its efficacy and safety are being compared to a placebo. The main therapeutic indication for mocravimod is to support and maintain treatment in AML patients receiving HCT. At the molecular level, mocravimod works by modulating the immune response, which may help in reducing complications associated with transplantation. It is classified pharmacologically as an immunomodulator.

Investigated diseases

Graft-versus-Host Disease (GvHD) – This condition occurs when donor cells attack the recipient's body after a stem cell or bone marrow transplant. It can be acute or chronic, with acute GvHD typically developing within the first 100 days post-transplant and chronic GvHD occurring later. Symptoms can vary widely, affecting the skin, liver, and gastrointestinal tract, among other organs. Acute GvHD often presents with skin rashes, liver dysfunction, and gastrointestinal issues like diarrhea. Chronic GvHD may lead to skin thickening, dry eyes, and joint stiffness. The progression and severity of GvHD can differ significantly among individuals.