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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Eduardo Olavarria
+44 (0)203 313 1000
e.olavarria@nhs.net


Ms Malika Souquieres
+33 (0)367510040
malika.souquieres@priothera.com


Ms Elisabeth Kueenburg
+33 (0)367510040
elisabeth.kueenburg@priothera.com


Study Location:

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Be Part of Research - Trial Details - A Phase III placebo-controlled efficacy and safety study of mocravimod as an adjunctive and maintenance treatment in acute myeloid leukemia patients undergoing allogeneic hematopoietic cell transplantation
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A Phase III placebo-controlled efficacy and safety study of mocravimod as an adjunctive and maintenance treatment in acute myeloid leukemia patients undergoing allogeneic hematopoietic cell transplantation

Recruiting

Open to: All Genders

Age: Adult

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Medical Conditions

Acute myeloid leukemia

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Priothera S.A.S., the study sponsor, is looking at the effects of a new medicine called mocravimod. Transplantation is a standard treatment for acute myeloid leukaemia (AML) but it is not always successful and the disease often returns. Donor T cells from a healthy donor can prevent the return of AML by attacking the patient’s cancer cells. Stem cell transplantation can cause complications. One major complication is graft-versus-host-disease (GvHD). This is where the donated cells attack the patient’s healthy cells and can cause damage to the patient’s body.
When given together with other standard-of-care drugs, mocravimod may help to block the migration of donated lymphocytes (a type of white blood cells that can attack other cells) to other parts of the body. This may retain the donated lymphocytes in the lymphoid tissues, such as bone marrow, to attack the remaining cancer cells to prevent the patient’s AML from returning.
The aim of this study is to assess the efficacy and safety of mocravimod compared to a placebo in adult participants with AML undergoing blood cell transplantation (HCT). These patients are at risk of developing complications linked with HCT namely graft-versus-host disease (GvHD), which occurs when the donated cells attack healthy cells. GvHD is currently prevented with a combination of drugs, yet this still remains a major potential complication of HCT.
In this study, mocravimod will be used in addition to the standard-of-care GvHD preventative drugs as it may block the movement of the donated cells, preventing them from attacking other parts of the body, thereby reducing GvHD. These donated cells then remain in the bone marrow tissue and may also attack the remaining cancer cells, thus preventing the AML from returning.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

30 Jun 2022 31 Mar 2025

Two thirds of participants will receive study drug and one third will receive placebo. Some of the study visits will take place whilst participants are hospitalised to undergo the transplantation. Participants will receive mocravimod or placebo daily, starting before the transplantation, up to 1 year after. The status of the AML disease will be periodically assessed by bone marrow aspirate and/or biopsy throughout the study. An independent committee will review the safety of all participants on a regular basis and may decide to discontinue participation if they observe any safety findings. The effects on relapse-free survival, overall survival, the occurrence of GvHD and quality of life will also be assessed.
Participants will only receive mocravimod/placebo during the treatment phase of the trial. Each participant ideally should complete the relapse-free survival and/or overall survival follow-up phase. The data support a clinical study to assess the efficacy and safety of mocravimod as an adjunctive and maintenance therapy for allogeneic HCT for a longer duration of treatment up to 1 year, which will be provided. The study drug will not be available for the treatment of patients in the study after the study treatment has ended. When the treatment period ends, the participants will receive the best available treatment that the study doctor considers most appropriate for their disease.


Patients aged between 18 and 75 years with AML undergoing allogeneic HCT

You can take part if:


Current inclusion criteria:
1. Subjects with a diagnosis of AML (excluding acute promyelocytic leukemia) according to the World Health Organization (WHO) 2022 classification of AML and related precursor neoplasms, including AML with myelodysplasia-related gene mutations.
2. Subjects with European LeukemiaNet (ELN) high-risk or intermediate-risk AML in CR1, intermediate-risk AML in CR1, or AML of any risk in CR2. (Complete remission with incomplete count recovery [CRi] is also allowable).
3. Subjects planned to undergo allogeneic HCT
4. Life expectancy ≥6 months at screening
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Male or female, age ≥18 yea


You may not be able to take part if:


Current exclusion criteria as of 19/07/2024:1. Planned use of anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis2. Planned use of serotherapy during conditioning, including ATG and alemtuzumab3. Planned ex vivo major graft manipulation, including T-cell depletion or CD34+ selection4. Subjects having received prior allogeneic HCT or recipients of a solid organ transplant5. Immunosuppressive drugs for concomitant disease. Subjects must be able to be off prednisone (> 10 mg/day) or other immunosuppressive medications for at least 3 days prior to the start of treatment of the study. Physiologic replacement dosing of hydrocortisone is permissible.6. Require treatments for cardiac dysfunction7. Subjects with acute promyelocytic leukemia8. Blast crisis of chronic myeloid leukemia9. Cardiac dysfunction10. Pulmonary dysfunction11. Significant liver disease or liver injury or known history of alcohol abuse, chronic liver or biliary disease. Hepatic dysfunction as defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN); or total bilirubin >1.5 x ULN12. Renal dysfunction with creatinine clearance <45 ml/min by the Cockcroft-Gault formula13. History of stroke or intracranial hemorrhage within 1 year prior to screening14. Active clinically significant infection (viral, bacterial, or fungal) that requires ongoing antimicrobial therapy and in the judgment of the investigator represents a risk to proceeding with HCT

Previous exclusion criteria:1. Planned use of anti-thymocyte globulin (ATG), post-transplantation cyclophosphamide, sirolimus, mycophenolate mofetil, abatacept, or any approved or non-approved medication other than MTX plus CsA or MTX plus TAC for GVHD prophylaxis2. Planned use of serotherapy during conditioning, including ATG and alemtuzumab3. Planned ex vivo major graft manipulation, including T-cell depletion or CD34+ selection4. Subjects having received prior allogeneic HSCT or recipients of a solid organ transplant5. Immunosuppressive drugs for concomitant disease. Subjects must be able to be off prednisone (>10 mg/day) or other immunosuppressive medications for at least 3 days prior to the start of treatment of the study. Physiologic replacement dosing of hydrocortisone is permissible.6. Require treatments for cardiac dysfunction7. Subjects with acute promyelocytic leukemia8. Blast crisis of chronic myeloid leukemia9. Cardiac dysfunction10. Pulmonary dysfunction11. Significant liver disease or liver injury or known history of alcohol abuse, chronic liver or biliary disease. Hepatic dysfunction as defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN); or total bilirubin >1.5 x ULN12. Renal dysfunction with creatinine clearance <60 ml/min by the Cockcroft-Gault formula13. History of stroke or intracranial hemorrhage within 1 year prior to screening14. Active clinically significant infection (viral, bacterial, or fungal) that requires ongoing antimicrobial therapy and in the judgment of the investigator represents a risk to proceeding with HSCT


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

Mocravimod is a new drug that is still under investigation to be used as an add-on and maintenance treatment to reduce the risk of the disease coming back while reducing the risk of GvHD. There may or may not be a medical benefit to participants. The study medication may help AML or it may not. The participant’s AML might not get better while they are in this study. Information from this study will add to what is known about the disease. This new knowledge might help researchers come up with new tests or medications to help others in the future.
Mild to serious side effects of the study drug may be experienced but these are likely to be outweighed by the potential benefits. Participants will be given medicines to help lessen the main side effects. Women of childbearing potential will be informed of the risks associated with pregnancy and will be offered options to avoid pregnancy. Breach of confidentiality may be a concern therefore a participant will only be identified by means of a participant identification number and their identity will never be disclosed.
1. Blood sampling may cause distress, mild pain, redness, or bruising – good practices will minimise the discomfort
2. Bone marrow/tissue biopsy sampling may cause pain and discomfort – pain medication will be provided
3. Eye examination: Dilation of the eyes can cause blurry vision and light sensitivity - participants can wear sunglasses and have someone drive them home afterwards
4. Administration of fluorescent dye may cause a yellow tint to the skin and urine will be yellow-orange
5. A MUGA scan with a small amount of radioactive material will be injected - with a small dose of radioactivity the potential health risks from radiation exposure are low compared with the potential benefit
6. A CT scan. The small amount of radiation a person receives that poses a risk to their health is considered justified by the potential benefits. Women must test negative for pregnancy before the scan.

Dr Eduardo Olavarria
+44 (0)203 313 1000
e.olavarria@nhs.net


Ms Elisabeth Kueenburg
+33 (0)367510040
elisabeth.kueenburg@priothera.com


Ms Malika Souquieres
+33 (0)367510040
malika.souquieres@priothera.com



The study is sponsored by Priothera S.A.S. and funded by Priothera S.A.S..



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Read full details for Trial ID: ISRCTN12632431

Or CPMS 49498

Last updated 19 July 2024

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