The research company MitoImmune Therapeutics is conducting the clinical trial Evaluate the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT (Capella).
Evaluate the efficacy and safety for the prevention of oral mucositis and PK of MIT-001 for lymphoma or multiple myeloma patients receiving conditioning chemotherapy for autologous hematopoietic stem cell transplantation(auto-HSCT).
It is planned to include 75 participants.
Actual study start date is February 1, 2022. The researchers expect to complete the study by April 30, 2024.
One primary outcome measure is the incidence of Severe Oral Mucositis(SOM), OM is evaluated using the World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3. OM grading scale Grade 0 = Normal Grade 1 = Erythema and Soreness Grade 2 = Ulceration but can eat solid foods Grade 3 = Ulceration,diet limited to liquid (due to mucositis) Grade 4 = Ulceration of severity that patient requires parenteral feeding (due to mucositis).
Further details can be found here:https://ichgcp.net/clinical-trials-registry/NCT05493800.