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"MIRO" Molecularly Oriented Immuno-radio-therapy

NCT02710643 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-06-21

No results posted yet for this study

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

Conditions

  • Follicular Lymphoma, Grade 1
  • Follicular Lymphoma, Grade 2
  • Follicular Lymphoma Grade 3A

Interventions

DRUG

OFATUMUMAB

8 weekly infusion of 1000 mg total dose

Sponsors & Collaborators

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Alessandro Pulsoni, MD · Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-04-30
Completion
2022-04-07

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02710643 on ClinicalTrials.gov