Trial · NCT01232556
A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
NCT01232556, Phase 3, Terminated, Pfizer; results first posted 2018-08-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy. Trials, record NCT01232556. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01232556
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
- NCT number
- NCT01232556
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 338 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Lymphoma, Non-Hodgkin
- Interventions
- Inotuzumab ozogamicin, Rituximab, rituximab + gemcitabine, rituximab +bendamustine
- First posted
- 2010-11-02
- Last updated
- 2019-01-08
- Other registries' IDs
- eudract:2010-020147-12
- Results first posted
- 2018-08-21
- Limitations and caveats
Interpretation of the results is limited by the small number of subjects analyzed and follow-up period was shortened due to the early termination of the study.~Adverse Events were calculated using the safety populations.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | 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. |
| Primary | Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population) | 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.. |
| Secondary | Progression-Free Survival (PFS) | 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 decreasing in size. 2. At least a 50% increase from nadir in the sum of the product diameters of any previously involved nodes, or in a single involved node, or the size of other lesions. 3. At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis. |
| Secondary | Percentage of Participants With A Best Overall Response of CR or Partial Response (PR) Per NCI International Response Criteria for NHL | 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 usually assessable and no measurable disease should be present. 5. No new sites of disease. The 95% CI was determined using the exact method based on binomial distribution. |
| Secondary | Percentage of Participants With A Best Overall Response of CR, Unconfirmed CR (unCR), PR, or Unconfirmed PR (unPR) Per NCI International Response Criteria for NHL | 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 usually assessable and no measurable disease should be present. 5. No new sites of disease. unCR and unPR means didn't have confirmatory assessment (including bone marrow assessment for CR). The 95% CI was determined using the exact method based on binomial distribution. |
| Secondary | Duration of Response | 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. |
| Secondary | Health Status as Assessed by the European Quality of Life 5 Dimension (EQ-5D) Questionnaire | 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 scores for EQ-5D index were computed at approximately Week 12. The overall treatment comparisons were estimated at approximately Week 12. |
| Secondary | Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy for Lymphoma (FACT-Lym) Questionnaire | 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 the past 7 days. FACT-Lym total score, which was reported, was derived based on FACT-Lym scoring guideline (Version 4). The range of FACT-Lym total score is 0 to 168. Higher scores mean better outcomes. The average post-baseline FACT-Lym total scores were computed at approximately Week 12. The overall treatment comparisons were estimated at approximately Week 12. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From randomization up to 5 years after last dose or up to final study visit, whichever occurs first. | ITT Population. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | 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. | ITT Population | Months | MEDIAN |
| SECONDARY | Percentage of Participants With A Best Overall Response of CR or Partial Response (PR) Per NCI International Response Criteria for NHL | 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. | ITT Population | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With A Best Overall Response of CR, Unconfirmed CR (unCR), PR, or Unconfirmed PR (unPR) Per NCI International Response Criteria for NHL | 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. | ITT Population | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response | 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. | ITT population; only participants with a CR, unCR, PR, or unPR were included in the analysis | Months | MEDIAN |
| SECONDARY | Health Status as Assessed by the European Quality of Life 5 Dimension (EQ-5D) Questionnaire | Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported | ITT population | Unit on a scale | MEAN |
| SECONDARY | Health Related Quality of Life as Assessed by the Functional Assessment of Cancer Therapy for Lymphoma (FACT-Lym) Questionnaire | Assessed at Day 1 of each cycle and 6-9 weeks after the last dose, Cycle 3 (Week 12) reported | ITT population | Unit on a scale | MEAN |
| PRIMARY | Percentage of Participants With a Treatment Emergent Adverse Event (TEAE) (Safety Population) | Up to 20 weeks after the first dose of study drug | Safety Population - included all participants who received at least 1 dose of test article (either inotuzumab ozogamicin administrated in combination with rituximab or investigator's choice). This population only excluded participants who never received any test article. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Inotuzumab Ozogamicin+Rituximab | 9.5 | 95% Confidence Interval 7.0 to 14.5 | Months | |
| Overall Survival | Rituximab+Gemcitabine or Rituximab+Bendamustine | 9.5 | 95% Confidence Interval 7.7 to 14.1 | Months | |
| Progression-Free Survival (PFS) | Inotuzumab Ozogamicin+Rituximab | 3.7 | 95% Confidence Interval 2.9 to 5.0 | Months | |
| Progression-Free Survival (PFS) | Rituximab+Gemcitabine or Rituximab+Bendamustine | 3.5 | 95% Confidence Interval 2.8 to 4.9 | Months | |
| Percentage of Participants With A Best Overall Response of CR or Partial Response (PR) Per NCI International Response Criteria for NHL | Inotuzumab Ozogamicin+Rituximab | 29.5 | 95% Confidence Interval 22.70 to 37.08 | Percentage of Participants | |
| Percentage of Participants With A Best Overall Response of CR or Partial Response (PR) Per NCI International Response Criteria for NHL | Rituximab+Gemcitabine or Rituximab+Bendamustine | 29.7 | 95% Confidence Interval 22.94 to 37.08 | Percentage of Participants | |
| Percentage of Participants With A Best Overall Response of CR, Unconfirmed CR (unCR), PR, or Unconfirmed PR (unPR) Per NCI International Response Criteria for NHL | Inotuzumab Ozogamicin+Rituximab | 41.0 | 95% Confidence Interval 33.40 to 48.85 | Percentage of Participants | |
| Percentage of Participants With A Best Overall Response of CR, Unconfirmed CR (unCR), PR, or Unconfirmed PR (unPR) Per NCI International Response Criteria for NHL | Rituximab+Gemcitabine or Rituximab+Bendamustine | 43.6 | 95% Confidence Interval 36.07 to 51.36 | Percentage of Participants | |
| Duration of Response | Inotuzumab Ozogamicin+Rituximab | 11.56 | 95% Confidence Interval 7.8 to NA | Months | |
| Duration of Response | Rituximab+Gemcitabine or Rituximab+Bendamustine | 6.93 | 95% Confidence Interval 5.5 to 10.8 | Months |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Inotuzumab Ozogamicin Plus (+) Rituximab | 166 | |
| Overall Study | STARTED | Rituximab+Gemcitabine or Rituximab+Bendamustine | 172 | |
| Overall Study | Treated | Inotuzumab Ozogamicin Plus (+) Rituximab | 165 | |
| Overall Study | Treated | Rituximab+Gemcitabine or Rituximab+Bendamustine | 167 | |
| Overall Study | COMPLETED | Inotuzumab Ozogamicin Plus (+) Rituximab | 7 | |
| Overall Study | COMPLETED | Rituximab+Gemcitabine or Rituximab+Bendamustine | 1 | |
| Overall Study | NOT COMPLETED | Inotuzumab Ozogamicin Plus (+) Rituximab | 159 | |
| Overall Study | NOT COMPLETED | Rituximab+Gemcitabine or Rituximab+Bendamustine | 171 |
Source ClinicalTrials.gov
Adverse events328
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin+Rituximab | 24 | 164 | |
| other | Anaemia | Blood and lymphatic system disorders | Rituximab+Gemcitabine or Rituximab+Bendamustine | 43 | 167 | |
| other | Leukopenia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin+Rituximab | 37 | 164 | |
| other | Leukopenia | Blood and lymphatic system disorders | Rituximab+Gemcitabine or Rituximab+Bendamustine | 54 | 167 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin+Rituximab | 28 | 164 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Rituximab+Gemcitabine or Rituximab+Bendamustine | 39 | 167 | |
| other | Neutropenia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin+Rituximab | 57 | 164 | |
| other | Neutropenia | Blood and lymphatic system disorders | Rituximab+Gemcitabine or Rituximab+Bendamustine | 81 | 167 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Inotuzumab Ozogamicin+Rituximab | 101 | 164 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rituximab+Gemcitabine or Rituximab+Bendamustine | 64 | 167 |
1 to 10 of 328Source ClinicalTrials.gov
See all 328 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Inotuzumab Ozogamicin+Rituximab | ||
| Total, all-cause mortality | Rituximab+Gemcitabine or Rituximab+Bendamustine | ||
| Total, other adverse events | Inotuzumab Ozogamicin+Rituximab | 155 | 164 |
| Total, other adverse events | Rituximab+Gemcitabine or Rituximab+Bendamustine | 158 | 167 |
| Total, serious adverse events | Inotuzumab Ozogamicin+Rituximab | 61 | 164 |
| Total, serious adverse events | Rituximab+Gemcitabine or Rituximab+Bendamustine | 63 | 167 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Inotuzumab Ozogamicin+Rituximab vs Rituximab+Gemcitabine or Rituximab+Bendamustine: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01232556
GET https://conductscience.org/api/trials/v1/NCT01232556/results?page=2