Overview

Peptide Receptor Radionuclide Therapy With 90Y-Dotatoc in Relapsed/Refractory Diffuse Large B Cell and Mantle Cell Lymphomas

Status:
Terminated

Trial end date:
2018-02-23

Target enrollment:

Participant gender:

Summary

This is a prospective, single arm,single centre open-label, phase II study in relapsed or refractory DLBCL and MCL non-Hodgkin's lymphoma (NHL), not suitable to other therapies, included HDCT, or patients relapsed after high-dose chemotherapy (HDCT) with autologous stem-cell transplantation (ASCT), treated with peptide receptor radionuclide therapy with 90Y-Dotatoc. Each patient will receive a maximum cumulative 90Y-DOTATOC activity of 11.1 GBq (300 mCi), divided into 4 cycles (1.8 - 2.8 gigabequerel (GBq) for each cycle) with an interval of 6 - 8 weeks between cycles. The 90Y-DOTATOC will be slowly infused intravenously. 35 patients will be enrolled in 36 months in two stages (18 patients in the first stage, if 2 or fewer patients will show an objective response, the study will be closed).

Phase:

Phase 2

Details

Lead Sponsor:

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Treatments:

Edotreotide
Octreotide