Trial · NCT00268203
Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma
NCT00268203, Phase 2, Completed, GlaxoSmithKline; results first posted 2013-12-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma. Trials, record NCT00268203. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00268203
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma
- NCT number
- NCT00268203
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 765 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Lymphoma, Non-Hodgkin
- Interventions
- Iodine I 131 Tositumomab Therapeutic Regimen
- First posted
- 2005-12-22
- Last updated
- 2017-01-09
- Results first posted
- 2013-12-09
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response | From randomization until the first documented complete response or partial response (up to 161 months) | A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter \[SPPD\] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. |
| Primary | Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response | From randomization until the first documented complete response or partial response (up to 161 months) | A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or partial response (PR: greater than or equal to a 50% decrease in the sum of the product of perpendicular diameter \[SPPD\] determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease). Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart. |
| Primary | Duration of Response for Participants With Unconfirmed Response (CR+PR) | From the time of the first documented response (CR or PR) until disease progression (up to 161 months) | Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. |
| Primary | Duration of Response for Participants With Confirmed Response (CR+PR) | From the time of the first documented response (CR or PR) until disease progression (up to 161 months) | Duration of response is defined as the time from the first documented CR (the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms) or PR (greater than or equal to a 50% decrease in the SPPD determined at Baseline; no increase in the size of the other nodes, liver, or spleen; no new sites of disease) until disease progression (PD). PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. Response was evaluated by an investigator per guidelines developed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart. |
| Primary | Duration of Response (DOR) in Unconfirmed Complete Responders | From the time of the first documented unconfirmed CR until PD (up to 161 months) | DOR is defined as the time from the first documented response to the first documented disease progression. Unconfirmed CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. Response was evaluated by an investigator per guidelines developed by The International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma. |
| Primary | Duration of Response (DOR) in Confirmed Complete Responders | From the time of the first documented CR until PD (up to 161 months) | DOR is defined as the time from the first documented response to the first documented disease progression. CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and all disease-related symptoms. A confirmed response (CR and PR) requires that the response be confirmed by another response (same or better) at least 4 weeks apart. |
| Primary | Time to Progression or Death | From the treatment start date to the first documented incidence of disease progression (PD) or death (up to 161 months) | Time to progression is defined as the time from the treatment start date to the first documented incidence of disease progression (PD) or death. PD is defined as greater than or equal to a 50% increase from nadir in the SPPD for all measurable disease. Lesion changes believed to represent measurement variation associated with radiographic technique should not be classified as PD. |
| Secondary | Time to Treatment Failure | From the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy, or death (up to 161 months) | Time to treatment failure is defined as the time from the date of the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy for lymphoma, or death study withdrawal for any reason. Participants withdrawn for reasons other than progression or death were censored at their date of withdrawal. |
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 | Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response | From randomization until the first documented complete response or partial response (up to 161 months) | Intent-to-Treat (ITT) Population: participants receiving any study drug. Only those participants evaluable for unconfirmed response (those with at least one response assessment) were analyzed. | Participants | NUMBER |
| PRIMARY | Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response | From randomization until the first documented complete response or partial response (up to 161 months) | Intent-to-Treat (ITT) Population: participants receiving any study drug. Only those participants evaluable for confirmed response (those with at least one response assessment) were analyzed. | Participants | NUMBER |
| PRIMARY | Duration of Response for Participants With Unconfirmed Response (CR+PR) | From the time of the first documented response (CR or PR) until disease progression (up to 161 months) | ITT Population. Only those participants with an unconfirmed CR or PR were analyzed for duration of unconfirmed response. Participants who did not have disease progression were censored in the analysis at the date of their last contact. | Months | MEDIAN |
| PRIMARY | Duration of Response for Participants With Confirmed Response (CR+PR) | From the time of the first documented response (CR or PR) until disease progression (up to 161 months) | ITT Population. Only those participants with a confirmed CR or PR were analyzed for duration of confirmed response. Participants who did not have disease progression were censored in the analysis at the date of their last contact. | Months | MEDIAN |
| PRIMARY | Duration of Response (DOR) in Unconfirmed Complete Responders | From the time of the first documented unconfirmed CR until PD (up to 161 months) | ITT Population. Only those participants with an unconfirmed CR were included in this analysis of duration of response. Participants who did not have disease progression were censored in the analysis at the date of their last contact. | Months | MEDIAN |
| PRIMARY | Duration of Response (DOR) in Confirmed Complete Responders | From the time of the first documented CR until PD (up to 161 months) | ITT Population. Only those participants with a confirmed CR were included in this analysis of duration of response. Participants who did not have disease progression were censored in the analysis at the date of their last contact. | Months | MEDIAN |
| PRIMARY | Time to Progression or Death | From the treatment start date to the first documented incidence of disease progression (PD) or death (up to 161 months) | ITT Population. Participants who did not have disease progression or death were censored in the analysis at the date of their last contact. | Months | MEDIAN |
| SECONDARY | Time to Treatment Failure | From the dosimetric dose to the first occurrence of the following: treatment withdrawal, decision to seek additional therapy, study removal, disease progression, receipt of alternative therapy, or death (up to 161 months) | ITT Population. Participants who did not experience treatment failure were censored at the date of their last contact. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response | Tositumomab and Iodine I-131 Tositumomab | CR or PR | 437 | Participants | |
| Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response | Tositumomab and Iodine I-131 Tositumomab | CR | 238 | Participants | |
| Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response | Tositumomab and Iodine I-131 Tositumomab | CR or PR | 339 | Participants | |
| Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response | Tositumomab and Iodine I-131 Tositumomab | CR | 196 | Participants | |
| Duration of Response for Participants With Unconfirmed Response (CR+PR) | Tositumomab and Iodine I-131 Tositumomab | 21.0 | 95% Confidence Interval 17.3 to NA | Months | |
| Duration of Response for Participants With Confirmed Response (CR+PR) | Tositumomab and Iodine I-131 Tositumomab | NA | 95% Confidence Interval NA to NA | Months | |
| Duration of Response (DOR) in Unconfirmed Complete Responders | Tositumomab and Iodine I-131 Tositumomab | NA | 95% Confidence Interval NA to NA | Months | |
| Duration of Response (DOR) in Confirmed Complete Responders | Tositumomab and Iodine I-131 Tositumomab | NA | 95% Confidence Interval NA to NA | Months | |
| Time to Progression or Death | Tositumomab and Iodine I-131 Tositumomab | 9.2 | 95% Confidence Interval 6.8 to 10.8 | Months | |
| Time to Treatment Failure | Tositumomab and Iodine I-131 Tositumomab | 9.0 | 95% Confidence Interval 6.3 to 10.4 | Months |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tositumomab and Iodine I-131 Tositumomab | 765 | |
| Overall Study | Completed 2 Years of Follow-up | Tositumomab and Iodine I-131 Tositumomab | 62 | |
| Overall Study | COMPLETED | Tositumomab and Iodine I-131 Tositumomab | 118 | |
| Overall Study | NOT COMPLETED | Tositumomab and Iodine I-131 Tositumomab | 647 |
Source ClinicalTrials.gov
Adverse events528
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 | Absolute neutrophil count < 1000 cells/mm^3 | Investigations | Tositumomab and Iodine I-131 Tositumomab | 293 | 765 | |
| other | Platelets < 50000 cells/mm^3 | Investigations | Tositumomab and Iodine I-131 Tositumomab | 278 | 765 | |
| other | White blood cells < 2000 cells/mm^3 | Investigations | Tositumomab and Iodine I-131 Tositumomab | 260 | 765 | |
| other | Hemoglobin < 8.0 grams per deciliter | Investigations | Tositumomab and Iodine I-131 Tositumomab | 91 | 765 | |
| other | Fatigue | General disorders | Tositumomab and Iodine I-131 Tositumomab | 166 | 765 | |
| other | Pyrexia | General disorders | Tositumomab and Iodine I-131 Tositumomab | 82 | 765 | |
| other | Chills | General disorders | Tositumomab and Iodine I-131 Tositumomab | 57 | 765 | |
| other | Oedema peripheral | General disorders | Tositumomab and Iodine I-131 Tositumomab | 23 | 765 | |
| other | Pain | General disorders | Tositumomab and Iodine I-131 Tositumomab | 19 | 765 | |
| other | Asthenia | General disorders | Tositumomab and Iodine I-131 Tositumomab | 13 | 765 |
1 to 10 of 528Source ClinicalTrials.gov
See all 528 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tositumomab and Iodine I-131 Tositumomab | ||
| Total, other adverse events | Tositumomab and Iodine I-131 Tositumomab | 650 | 765 |
| Total, serious adverse events | Tositumomab and Iodine I-131 Tositumomab | 204 | 765 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00268203
GET https://conductscience.org/api/trials/v1/NCT00268203/events?page=2