A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
TerminatedPhase 3Results postedLast updated 8 January 2019
What this trial tests
Phase 3 trial testing Inotuzumab ozogamicin in Lymphoma, Non-Hodgkin in 338 participants. Terminated before completion.
18 and older, any sex, with Lymphoma, Non-Hodgkin. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall SurvivalPrimary· From randomization up to 5 years after last dose or up to final study visit, whichever occurs first.
Overall Survival (OS) was defined as the time from randomization to death due to any cause, censoring at the date of last contact or the end of the study. The Kaplan-Meier method was used to determine OS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.
Group
Value
95% CI
Inotuzumab Ozogamicin+Rituximab
9.5
7.0 – 14.5
Rituximab+Gemcitabine or Rituximab+Bendamustine
9.5
7.7 – 14.1
Progression-Free Survival (PFS)Secondary· From randomization up to 2 years or final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
PFS is defined as time from date of randomization to date of progressive disease (PD, including investigator's claim of clinical progression), date of death from any cause, or initiation of a new treatment for the lymphoma due to persistent/refractory disease. The Kaplan-Meier method was used to determine PFS. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.
PD requires the following:
1. Appearance of any new lesion more than 1.5 cm in any axis during or at the end of treatment, even if other lesions are d
Group
Value
95% CI
Inotuzumab Ozogamicin+Rituximab
3.7
2.9 – 5.0
Rituximab+Gemcitabine or Rituximab+Bendamustine
3.5
2.8 – 4.9
Percentage of Participants With A Best Overall Response of CR or Partial Response (PR) Per NCI International Response Criteria for NHLSecondary· Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
CR is defined as disappearance of all detectable clinical evidence of disease (including cleared infiltrate on repeat bone marrow aspirate/biopsy if lymphoma involvement of bone marrow before treatment).
Partial Response (PR) requires the following:
1. ≥50 % decrease in SPD of the six largest dominant nodes or nodal masses.
2. No increase in the size of other nodes, liver, or spleen.
3. Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter.
4. With the exception of splenic and hepatic nodules, involvement of other organs is us
Group
Value
95% CI
Inotuzumab Ozogamicin+Rituximab
29.5
22.70 – 37.08
Rituximab+Gemcitabine or Rituximab+Bendamustine
29.7
22.94 – 37.08
Percentage of Participants With A Best Overall Response of CR, Unconfirmed CR (unCR), PR, or Unconfirmed PR (unPR) Per NCI International Response Criteria for NHLSecondary· Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
CR is defined as disappearance of all detectable clinical evidence of disease (including cleared infiltrate on repeat bone marrow aspirate/biopsy if lymphoma involvement of bone marrow before treatment).
Partial Response (PR) requires the following:
1. ≥50 % decrease in SPD of the six largest dominant nodes or nodal masses.
2. No increase in the size of other nodes, liver, or spleen.
3. Splenic and hepatic nodules must regress by ≥50% in the SPD, or for single nodules, in the greatest transverse diameter.
4. With the exception of splenic and hepatic nodules, involvement of other organs is us
Group
Value
95% CI
Inotuzumab Ozogamicin+Rituximab
41.0
33.40 – 48.85
Rituximab+Gemcitabine or Rituximab+Bendamustine
43.6
36.07 – 51.36
Duration of ResponseSecondary· Up to 2 years from first study drug dose or up to final study visit, whichever occurs first, including but not limited to planned assessments scheduled approximately every 12 weeks.
The duration of overall response is measured from the first date of response until the first date that the progressive disease (PD) or death is objectively documented. The hazard ratio and corresponding 95% 2-sided confidence interval were calculated using stratified Cox proportional hazard regression.
Group
Value
95% CI
Inotuzumab Ozogamicin+Rituximab
11.56
7.8 – NA
Rituximab+Gemcitabine or Rituximab+Bendamustine
6.93
5.5 – 10.8
Health Status as Assessed by the European Quality of Life 5 Dimension (EQ-5D) QuestionnaireSecondary· Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported
EQ-5D consists of a descriptive system and an EQ visual analogue scale. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The scale, the best state is marked 100 and the worst state is marked 0, is to help the participant to say how good or bad a health state is. EQ-5D index, which was reported, was derived based on US weight. The range of EQ-5D index is -0.109 to 1.00. Higher scores mean better outcomes. The average post-baseline
Group
Value
95% CI
Inotuzumab Ozogamicin+Rituximab
0.79
0.76 – 0.82
Rituximab+Gemcitabine or Rituximab+Bendamustine
0.77
0.74 – 0.79
Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy for Lymphoma (FACT-Lym) QuestionnaireSecondary· Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported
FACT-Lym is a questionnaire that begins with 27 items covering four core Health-Related Quality of Life subscales: Physical Well-being (7 items), Social/Family Well-being (7), Emotional Well-being (6), and Functional Well-being (7). The FACT-Lym also includes an additional concerns subscale (15 items). It also asks participants about their concerns about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. The participants were requested to circle one number on a 0 to 4 points scale per line to indicate how true each statement has been for him/her during
Group
Value
95% CI
Inotuzumab Ozogamicin+Rituximab
120.07
116.74 – 123.41
Rituximab+Gemcitabine or Rituximab+Bendamustine
116.96
113.74 – 120.19
Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population)Primary· Up to 20 weeks after the first dose of study drug
Includes all TEAEs: Any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration..
% participants with a TEAE
Group
Value
95% CI
Inotuzumab Ozogamicin+Rituximab
98.8
Rituximab+Gemcitabine or Rituximab+Bendamustine
100.0
% participants with serious TEAE
Group
Value
95% CI
Inotuzumab Ozogamicin+Rituximab
37.2
Rituximab+Gemcitabine or Rituximab+Bendamustine
37.7
% participants with Grade 3 or 4 TEAE
Group
Value
95% CI
Inotuzumab Ozogamicin+Rituximab
79.9
Rituximab+Gemcitabine or Rituximab+Bendamustine
79.6
% participants with Grade 5 TEAE
Group
Value
95% CI
Inotuzumab Ozogamicin+Rituximab
14.6
Rituximab+Gemcitabine or Rituximab+Bendamustine
13.8
% participants for study drug discontinuation
Group
Value
95% CI
Inotuzumab Ozogamicin+Rituximab
25.0
Rituximab+Gemcitabine or Rituximab+Bendamustine
18.0
% participants with dose reductions due to TEAEs
Group
Value
95% CI
Inotuzumab Ozogamicin+Rituximab
27.4
Rituximab+Gemcitabine or Rituximab+Bendamustine
29.3
% participants for study drug stopped temporarily
Group
Value
95% CI
Inotuzumab Ozogamicin+Rituximab
31.1
Rituximab+Gemcitabine or Rituximab+Bendamustine
46.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 22 weeks after the informed consent.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06554626 — Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL
· Phase 2
· recruiting
NCT06427330 — Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia
· Phase 2
· recruiting
NCT06387121 — Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Adult Ph- B-ALL
· Phase 2
· recruiting
NCT05645718 — Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed
· Phase 2
· recruiting
NCT05748171 — A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With Firs
· Phase 2
· recruiting
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· recruiting
NCT06470438 — A Study of JNJ-88998377 for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
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· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 8 January 2019
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/NCT01232556.