Efficacy and Safety of Luspatercept for the Treatment of Anemia Due to MDS With del5q, Refractory/Resistant/Intolerant to Prior Treatments, RBC-TD

PHASE2RecruitingINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

November 3, 2022

Primary Completion Date

December 3, 2024

Study Completion Date

December 3, 2029

Conditions
Myelodysplastic SyndromesDel(5Q)AnemiaTransfusion-dependent Anemia
Interventions
DRUG

Luspatercept Injection [Reblozyl]

"Eligible subjects will receive luspatercept (ACE-536): starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg (with a maximum total dose of 168 mg).~All subjects who have received at least one dose of luspatercept should undergo follow-up evaluations after day 169 with Assessment visits every 24 weeks (168 days) up to 2 years to evaluate evidence of clinical benefit."

Trial Locations (23)

89133

RECRUITING

Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria

Unknown

NOT_YET_RECRUITING

A.O. SS. Antonio e Biagio e Cesare Arrigo Ospedale Civile, Alessandria

RECRUITING

A.O.U. Ospedali Riuniti, Ancona

NOT_YET_RECRUITING

A.O. S. Giuseppe Moscati, Avellino

NOT_YET_RECRUITING

Ospedale degli Infermi, Biella

NOT_YET_RECRUITING

A.O.U. G. Rodolico San Marco, Catania

NOT_YET_RECRUITING

ARNAS Garibaldi, PO Nesima, Catania

NOT_YET_RECRUITING

ASL TO 4 - Ospedale Chivasso, Chivasso

NOT_YET_RECRUITING

Azienda Ospedaliera Annunziata, Cosenza

NOT_YET_RECRUITING

A.O.U. Careggi, Florence

NOT_YET_RECRUITING

A.O.U. Federico II, Napoli

NOT_YET_RECRUITING

A.O.U. Maggiore della Carità, Novara

NOT_YET_RECRUITING

A.O.U. Policlinico Paolo Giaccone, Palermo

NOT_YET_RECRUITING

Ospedale Civile Spirito Santo, Pescara

NOT_YET_RECRUITING

IRCCS di Reggio Emilia, Reggio Emilia

NOT_YET_RECRUITING

Ospedale S. Eugenio, Roma

NOT_YET_RECRUITING

Policlinico Tor Vergata, Roma

NOT_YET_RECRUITING

Policlinico Umberto I, Roma

NOT_YET_RECRUITING

A.O.U. San Giovanni di Dio e Ruggì D'Aragona, Salerno

NOT_YET_RECRUITING

Casa Sollievo della Sofferenza IRCCS, San Giovanni Rotondo

NOT_YET_RECRUITING

AO Santa Maria di Terni, Terni

NOT_YET_RECRUITING

A.O. Città della Salute e della Scienza, Torino

NOT_YET_RECRUITING

ASU Giuliano Isontina, Trieste

All Listed Sponsors
lead

Associazione Qol-one

OTHER