TheranosticTrials.org

Clinical Trial · NCT02488512

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

Overview

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).

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Phase

Phase 2

Contacts

Maddalena Sansovini, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02488512

Drug / Compound

DOTATOC

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Histologically confirmed relapsed or refractory DLBCL or MCL not suitable to other treatments.
  • Patients must have at least one bidimensional measurable lesion with long axis \> 15 mm at CT scan (MRI is allowed only if CT scan cannot be performed), according to Cheson Criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Patients with documented disease will be admitted to therapeutic phase only if the diagnostic PET/CT with 68Ga-DOTATOC images demonstrate a significant uptake in the tumour (SSR-positive tumour).

Exclusion

  • Previous autologous stem cell transplant in the last 2 months.
  • Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks.
  • Evidence of myelodysplastic syndrome or other hematologic diseases
  • Bone marrow invasion \> 25 %.