Periodic Reporting for period 2 - RITA-MI (Rituximab in Acute Myocardial Infarction)
Periodo di rendicontazione: 2017-09-01 al 2018-08-31
1. Aim of study
This is a phase 1 dose ranging, safety and side effect assessment study for a single dose of rituximab in ST-elevation myocardial infarction (STEMI) patients.
2. Hypothesis
I. Rituximab is safe in STEMI patients with an acceptable side effect profile.
II. Rituximab will temporarily deplete circulating B cells (below 0.005 X 109/liter) in STEMI patients.
3. Study Objectives
Primary outcome
• To assess the safety of rituximab in STEMI patients by monitoring their response to the drug in a controlled environment and on extended follow up.
Secondary outcomes
• To assess the effect of rituximab on circulating B cells immediately after administration and on extended follow up.
• To assess the effect of rituximab on circulating inflammatory and cardiovascular biomarkers.
Results:
The project had 4 steps or subgroups (6 patients each) corresponding to a stepwise increase in the dose of rituximab administered at the acute phase of MI. The first group had to receive a single infusion of 200mg of rituximab, the second group 500 mg, the third group 750 mg and the fourth group 1000 mg.
An authorisation from an independent DSMB (who reviewed all safety data) was needed at each step to progress through the 4 steps/subgroups of the project.
We have been able to complete the 3 first steps of the project, and have completed the inclusion of the first 2 patients in the 4th group. No major safety issues were raised. Rituximab infusion led to more than 99% depletion of B cell number in the blood at day 6 after the infusion.
Thus, so far, rituximab infusion at the acute phase of STEMI appears to be safe and profoundly depletes circulating B cells.
This is a phase 1 dose ranging, safety and side effect assessment study for a single dose of rituximab in ST-elevation myocardial infarction (STEMI) patients.
2. Hypothesis
I. Rituximab is safe in STEMI patients with an acceptable side effect profile.
II. Rituximab will temporarily deplete circulating B cells (below 0.005 X 109/liter) in STEMI patients.
3. Study Objectives
Primary outcome
• To assess the safety of rituximab in STEMI patients by monitoring their response to the drug in a controlled environment and on extended follow up.
Secondary outcomes
• To assess the effect of rituximab on circulating B cells immediately after administration and on extended follow up.
• To assess the effect of rituximab on circulating inflammatory and cardiovascular biomarkers.
Results:
The project had 4 steps or subgroups (6 patients each) corresponding to a stepwise increase in the dose of rituximab administered at the acute phase of MI. The first group had to receive a single infusion of 200mg of rituximab, the second group 500 mg, the third group 750 mg and the fourth group 1000 mg.
An authorisation from an independent DSMB (who reviewed all safety data) was needed at each step to progress through the 4 steps/subgroups of the project.
We have been able to complete the 3 first steps of the project, and have completed the inclusion of the first 2 patients in the 4th group. No major safety issues were raised. Rituximab infusion led to more than 99% depletion of B cell number in the blood at day 6 after the infusion.
Thus, so far, rituximab infusion at the acute phase of STEMI appears to be safe and profoundly depletes circulating B cells.