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

1 1

What is this study about?

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.

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).

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Salamanca Salamanca Spain
Universitaet Leipzig Leipzig Germany
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Ospedale Vito Fazzi Lecce Lecce Italy
Azienda Sanitaria Territoriale Di Pesaro E Urbino Pesaro Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Hospital Universitario 12 De Octubre Madrid Spain
Instytut Hematologii I Transfuzjologii Warsaw Poland
Hospital Universitario Virgen De Las Nieves Granada Spain
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Grande Ospedale Metropolitano Bianchi Melacrino Morelli Reggio Calabria Italy
Hospital Universitario Ramon Y Cajal Madrid Spain
Azienda Sanitaria Locale Di Taranto Taranto Italy
Institutul Clinic Fundeni Bucharest Romania
Spitalul Clinic Coltea Bucharest Romania
Institutul Regional De Oncologie Iasi Iasi Romania
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Azienda Sanitaria Territoriale Di Ascoli Piceno Ascoli Piceno Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Hopital Huriez Lille France
Hgziwhcy Ujyhnspyqvhck Du Lm Pbeqsyjp Madrid Spain
Ipktobbo Cgbzkt Dpbypmllkdlwzhmpt L'hospitalet De Llobregat Spain
Djswkfotmkoq Cxelhkg Ofdudybys Pgqdpfwoprut I Hgfmheeriny Wroclaw Poland
Uovnilkvhv Hkbkvjui Cgbcicy Cologne Germany
Cpad Dg Ndsbc Vandoeuvre Les Nancy France
Aekbnsl Obzcimotztb Nvsstqozl Sp Azdnwga E Bhbygy E C Ayyeae Ansimujolpx Alexandria Italy
Kljfmqrz dta Uessrdfanage Mcyzxomd Agy Munich Germany
Ugdhobcmvpftyiyxbwalf Wonkqygxg Abe Wuerzburg Germany
Ueuwpjennwchoc Ctxdbka Kfupnoxqm Gdansk Poland
Movnubvtigsjpkgwxqftyewcxc Hkvcjvzzhurqxhzc Halle (Saale) Germany
Cbojhc Hbelinalhsp Rwinrqjf Dkdvrfsuvofvax Angers France
Hupkdzst Vnwk dpxuqlxf Barcelona Spain
Urqiohgkonhgogvcpjakh Dmofahhtqky Aui Duesseldorf Germany
Hskbctxq Uxsvcoovzmtlwn Skuimhozwi &iamjoq Hqrsmbc dv Hruwtskseda STRASBOURG, Alsace France
Skfcjhxscvd Petnyswwu Szmjogf Kflidzeym Idfkgvmfgki Mycaxnawwxm Svx W Kfrwnvtqih Katowice Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.07.2022
Germany Germany
Recruiting
01.07.2022
Italy Italy
Recruiting
01.07.2022
Poland Poland
Recruiting
01.07.2022
Romania Romania
Recruiting
01.07.2022
Spain Spain
Recruiting
01.07.2022

Trial locations

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.

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.

Trial ID:
2024-512752-38-00
Protocol code:
PKRPC001
NCT ID:
NCT05429632
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of Revumenib and Chemotherapy for Patients with Newly Diagnosed Acute Myeloid Leukemia with NPM1 Gene Mutation

    Recruiting

    1 1 1
    Austria Belgium Czechia France Germany Greece +7
  • A Study Comparing Two Treatment Schedules of Venetoclax and Azacitidine in Adults with Newly Diagnosed Acute Myeloid Leukemia Not Suitable for Intensive Treatment

    Recruiting

    1 1 1 1
    Investigated drugs:
    France Spain