A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy

An Open-Label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin Administered In Combination With Rituximab Compared To Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory CD22-Positive Aggressive Non-Hodgkin Lymphoma Who Are Not Candidates For Intensive High-Dose Chemotherapy(B1931008/3129K5-3303-WW)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221331

Enrollment

377

Registered

2010-12-09

Start date

2011-04-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-cell non-Hodgkin lymphoma

Interventions

investigational material(s) Generic name etc : inotuzumab ozogamicin (CMC-544) + rituximab INN of investigational material : inotuzumab ozogamicin, rituximab Therapeutic category code : 429 Other anti

inotuzumab ozogamicin 1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6 cycles control material(s) Generic name etc : Investigator's choice of (1) rituximab+gemcitabine, or (2) rituximab+bendam

gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days, 3 to 6 cycles (2) rituximab 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles

bendamustine 120 mg/m2 on days 1 and 2 by IV infusion every 28 days, 3 to 6 cycles

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Relapsed/refractory/persistent CD20+/CD22+ aggressive NHL (DLBCL, transformed indolent lymphoma with DLBCL, primary mediastinal large B-cell lymphomas) *Up to 3 prior regimens containing cytotoxic chemotherapies *Not candidates for intensive high-dose chemotherapy, with or without an autologous stem cell transplant

Exclusion criteria

Exclusion criteria: *Any prior allogeneic hematopoietic stem cell transplant; autotransplant within prior 4 months *Anti-CD22 treatment or radioimmunotherapy within prior 6 months *Contraindication to both investigator choice regimens *Chronic liver disease, history of veno-occlusive disease

Design outcomes

Primary

Measure	Time frame
efficacy confirmatory Overall survival	—

Secondary

Measure	Time frame
safety efficacy Safety and tolerability: incidence of adverse events by treatment arm Efficacy: overall response rate, progression free survival, duration of response Patient-reported health-related quality of life	—

Countries

Asia except Japan, Europe, Japan, North America, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026