NCT02488512 (itTRIOlym) is a Phase 2 clinical trial of 90Y-DOTATOC in DLBCL, sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS.

Who is sponsoring NCT02488512?

NCT02488512 is sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS.

What drugs are being tested in NCT02488512?

Interventions in NCT02488512: 90Y-DOTATOC.

What condition does NCT02488512 study?

NCT02488512 studies DLBCL, MCL, Recurrent Disease.

Is NCT02488512 still recruiting?

NCT02488512 is currently terminated. Last updated 19 March 2018.

Last reviewed 2018-03-19 · How we verify

NCT02488512: itTRIOlym

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Last updated 19 March 2018

What this trial tests

Phase 2 trial testing 90Y-DOTATOC in DLBCL in 1 participant. Terminated before completion.

Timeline

22 December 2016

Primary endpoint
23 February 2018

23 February 2018

Quick facts

Lead sponsor	Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	22 December 2016
Primary completion	23 February 2018
Estimated completion	23 February 2018
Sites	1 location across Italy

Drugs / interventions tested

90Y-DOTATOC — full drug profile →

Conditions studied

DLBCL — all drugs for DLBCL →
MCL — all drugs for MCL →
Recurrent Disease — all drugs for Recurrent Disease →

Sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS — full company profile →

Who can join

18 and older, any sex, with DLBCL or MCL. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for DLBCL

Currently open trials in the same condition.

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NCT06701357 — CR-CHOP+X in Previously Untreated DEL · Phase 2 · recruiting
NCT07335120 — A Real-world Data and Sample Compendium of Frail and/or Multiply Treated Large B-cell Lymphoma · recruiting

Other Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS trials

Trials by the same sponsor.

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NCT05861336 — GEM+Nab-Paclitaxel Plus Losartan Followed by Stereotactic Radiotherapy for Locally Advanced Pancreatic Cancer · Phase 2 · withdrawn
NCT03454750 — Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC) · Phase 2 · completed
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02488512 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Last refreshed: 19 March 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02488512.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing