MO-TRANS
Research type
Research Study
Full title
A prospective randomized, double-blind, placebo-controlled, multi-center phase IIb study to evaluate the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in adult in acute myeloid leukemia (AML) patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT)
IRAS ID
1004810
Contact name
Karen von Graevenitz
Contact email
Sponsor organisation
Priothera S.A.S.
Eudract number
2021-002864-36
ISRCTN Number
ISRCTN12632431
Clinicaltrials.gov Identifier
Research summary
The aim of this study is to assess the efficacy and safety of a drug called mocravimod compared to a placebo, in adult participants with acute myeloid leukaemia (AML) undergoing blood stem cell transplantation (HSCT). These patients are at risk of developing complications linked with HSCT 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 HSCT. 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. This study is a phase IIb, randomised, double-blind study. 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. The following study procedures will be performed: (a) physical examinations (b) eye, heart and lung examinations (c) blood tests, (d) urine tests (e) bone marrow aspirations (f) tissue biopsies (g) IV infusion of conditioning drugs (h) questionnaires.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
22/LO/0345
Date of REC Opinion
17 Jun 2022
REC opinion
Further Information Favourable Opinion