Table 4.

Inotuzumab ozogamicin studies

PhaseDescriptionIdentifierSample sizeStatus
IIIRandomized, in combination with rituximab, compared with rituximab plus bendamustine or rituximab plus gemcitabine, in patients with relapsed/refractory CD22+ aggressive NHL who are not candidates for high-dose chemotherapyNCT01232556377Recruiting
IIIRandomized, in combination with rituximab, compared with defined investigator's choice therapy in patients with relapsed or refractory CD22+ FLNCT00562965∼978Terminateda
IISingle-arm, single-agent, in patients with indolent NHL that is refractory to or has relapsed after rituximab and chemotherapy or radioimmunotherapy (56)NCT0086860880Recruiting
IISingle-arm, in combination with rituximab prior to HSCT, in patients with relapsed/refractory DLBCL (78)NCT0086708760Ongoing
I–IIIn combination with rituximab in patients with B-cell NHL (57)NCT00299494119Ongoing
IFirst-in-human study in patients with B-cell NHL (52)NCT0007374979Completed
ISingle-agent, in Japanese patients with FL (54)NCT0071792513Completed
IIn combination with R-CVP or R-GDP in patients with CD22+ NHLNCT01055496∼100Recruiting
IIn combination with rituximab in Japanese patients with B-cell NHL (79)NCT0072497110Completed
ISingle-agent and in combination with rituximab in patients with ALLNCT01134575∼40Recruiting

Abbreviations: DLBCL, diffuse large B-cell Non-Hodgkin lymphoma; R-CVP, rituximab, cyclophosphamide, vincristine, and prednisone; R-GDP, rituximab, gemcitabine, cisplatinum, and dexamethasone.

  • aEnrollment was discontinued because of poor enrollment and because it was unlikely that the study would meet the estimated enrollment of ∼978 subjects. The decision was not prompted by the identification of any safety signals in this or other studies. Active treatment and follow-up of the already enrolled subjects were continued.