At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
"MIRO" (Molecularly Oriented Immuno - Radio -Therapy): Multicenter Phase II Study for the Treatment of the Molecular Basis of Stage I / II Follicular Lymphoma With Local Radiotherapy With / Without Ofatumumab
In Brief
A Phase 2 clinical trial evaluating OFATUMUMAB for Follicular Lymphoma, Grade 1 and 2 related conditions. Completed, enrolled 110 participants across 27 sites.
Detailed Summary
Phase II prospective multicenter study for stage I/II Follicular Lymphoma treated with involved-field radiotherapy (IFRT) at doses of 24 Gy) with or without Ofatumumab for 8 weekly doses on molecular basis. Patients with positive basal Bcl-2 will be followed every 3 months and with Bcl-2 detection every 6 months for 3 years. Patient with negative basal Bcl-2 will be followed every 3 months without further Bcl-2 detection. Ofatumumab treatment will be administered to: 1. Patients with positive basal PCR for Bcl-2-IgH rearrangement in BM and/or PB, resulting still positive after IFRT; 2. Patients with positive basal PCR for Bcl-2-IgH in
Study Details
Timeline
Interventions
8 weekly infusion of 1000 mg total dose