A Phase 2 interventional study of Iodine I 131 Tositumomab Therapeutic Regimen in Lymphoma, Non-Hodgkin, sponsored by GlaxoSmithKline. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-09.
Sponsored by GlaxoSmithKline · Phase 2 and Interventional
This is a single arm, multi-center, expanded access study of Iodine I 131 Tositumomab (BEXXAR) therapeutic regimen for patients with relapsed or refractory low-grade or transformed low-grade non-Hodgkin's B-cell lymphoma. The primary objective is to make Iodine I 131 Tositumomab more broadly available to patients. Secondary endpoints will be to obtain additional safety and efficacy information for this treatment regimen. Post study drug administration follow-ups will continue for up to ten years. These will include blood-work and adverse event assessments for 13 weeks post dosing, patient response evaluations at Week 13, Months 6, 12, 18, 24, and Long-Term Follow-ups every 6 months until the elapse of 5 years from the dosimetric dose and then annually thereafter through year 10. Thyroid function will be monitored annually during Long-term follow-up.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 765 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive unlabeled Tositumomab (450 mg) followed by Tositumomab (35 mg) which has been trace-labeled with 5 mCi of Iodine-131 (dosimetric dose). Whole body counts using a gamma camera will be obtained 3 times between Days 0 and 7 following the dosimetric dose to determine a patient-specific mCi dose of Iodine-131 calculated to deliver the desired total body dose of radiation (either 65 cGy or 75 cGy). The therapeutic dose is administered 7-14 days after the dosimetric dose. Patients will receive unlabeled Tositumomab (450 mg) followed by Tositumomab (35 mg) labeled with the patient-specific dose of Iodine-131 (median dose in previous studies was approximately 85 mCi). Patients who are obese will be dosed based upon 137% of their calculated lean body mass. Patients will be treated with thyroid blocking medication at least 24 hours prior to the dosimetric dose and continuing for 14 days following the therapeutic dose.
Number of Participants With Unconfirmed Response (Complete Response or Partial Response) and Unconfirmed Complete Response
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.
Time frame: From randomization until the first documented complete response or partial response (up to 161 months)
Number of Participants With Confirmed Response (Complete Response or Partial Response) and Confirmed Complete Response
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.
Time frame: From randomization until the first documented complete response or partial response (up to 161 months)
Duration of Response for Participants With Unconfirmed Response (CR+PR)
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.
Time frame: From the time of the first documented response (CR or PR) until disease progression (up to 161 months)
Duration of Response for Participants With Confirmed Response (CR+PR)
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.
Time frame: From the time of the first documented response (CR or PR) until disease progression (up to 161 months)
Duration of Response (DOR) in Unconfirmed Complete Responders
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.
Time frame: From the time of the first documented unconfirmed CR until PD (up to 161 months)
Duration of Response (DOR) in Confirmed Complete Responders
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.
Time frame: From the time of the first documented CR until PD (up to 161 months)
Time to Progression or Death
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.
Time frame: From the treatment start date to the first documented incidence of disease progression (PD) or death (up to 161 months)
Time to Treatment Failure
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.
Time frame: 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)
| Milestone | Tositumomab and Iodine I-131 Tositumomab |
|---|---|
| Started | 765 |
| Completed 2 years of follow-up | 62 |
| Completed | 118 |
| Not completed | 647 |
| Withdrew: Lost to follow-up | 92 |
| Withdrew: Withdrawal by subject | 9 |
| Withdrew: Received other nhl therapy | 7 |
| Withdrew: Progressive disease | 359 |
| Withdrew: Death | 84 |
| Withdrew: Reason not specified | 34 |
| Withdrew: Completed 2 years of follow-up | 62 |
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.
| Participants | Tositumomab and Iodine I-131 Tositumomab |
|---|---|
| CR or PR | 437 |
| CR | 238 |
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.
| Participants | Tositumomab and Iodine I-131 Tositumomab |
|---|---|
| CR or PR | 339 |
| CR | 196 |
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.
| Months | Tositumomab and Iodine I-131 Tositumomab |
|---|---|
| Duration of Response for Participants With Unconfirmed Response (CR+PR) | 21.0 (17.3 to NA) |
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.
| Months | Tositumomab and Iodine I-131 Tositumomab |
|---|---|
| Duration of Response for Participants With Confirmed Response (CR+PR) | NA (NA to NA) |
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.
| Months | Tositumomab and Iodine I-131 Tositumomab |
|---|---|
| Duration of Response (DOR) in Unconfirmed Complete Responders | NA (NA to NA) |
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.
| Months | Tositumomab and Iodine I-131 Tositumomab |
|---|---|
| Duration of Response (DOR) in Confirmed Complete Responders | NA (NA to NA) |
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.
| Months | Tositumomab and Iodine I-131 Tositumomab |
|---|---|
| Time to Progression or Death | 9.2 (6.8 to 10.8) |
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.
| Months | Tositumomab and Iodine I-131 Tositumomab |
|---|---|
| Time to Treatment Failure | 9.0 (6.3 to 10.4) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tositumomab and Iodine I-131 Tositumomab | — | 204/765 (26.7%) | 650/765 (85%) |
| Event | Tositumomab and Iodine I-131 Tositumomab |
|---|---|
| Myelodysplastic syndromeNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 34/765 |
| PyrexiaGeneral disorders | 19/765 |
| Acute myeloid leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 18/765 |
| AnaemiaBlood and lymphatic system disorders | 16/765 |
| ThrombocytopeniaBlood and lymphatic system disorders | 16/765 |
| PancytopeniaBlood and lymphatic system disorders | 10/765 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 10/765 |
| Febrile neutropeniaBlood and lymphatic system disorders | 9/765 |
| NeutropeniaBlood and lymphatic system disorders | 9/765 |
| DehydrationMetabolism and nutrition disorders | 9/765 |
| Event | Tositumomab and Iodine I-131 Tositumomab |
|---|---|
| Absolute neutrophil count < 1000 cells/mm^3Investigations | 293/765 |
| Platelets < 50000 cells/mm^3Investigations | 278/765 |
| White blood cells < 2000 cells/mm^3Investigations | 260/765 |
| FatigueGeneral disorders | 166/765 |
| NauseaGastrointestinal disorders | 135/765 |
| AnaemiaBlood and lymphatic system disorders | 97/765 |
| Hemoglobin < 8.0 grams per deciliterInvestigations | 91/765 |
| PyrexiaGeneral disorders | 82/765 |
| ThrombocytopeniaBlood and lymphatic system disorders | 60/765 |
| ChillsGeneral disorders | 57/765 |
| Age, Continuous(Years) | Tositumomab and Iodine I-131 Tositumomab |
|---|---|
| Mean | 58.8 ± 11.5 |
| Gender(Participants) | Tositumomab and Iodine I-131 Tositumomab |
|---|---|
| Female | 354 |
| Male | 411 |
| Race/Ethnicity, Customized(participants) | Tositumomab and Iodine I-131 Tositumomab |
|---|---|
| White | 711 |
| Hispanic | 19 |
| Asian | 7 |
| Black | 20 |
| Native American | 1 |
| Portuguese | 1 |
| Middle Eastern | 1 |
| Iranian | 1 |
| Indian | 2 |
| Arab | 1 |
| Peruvian | 1 |
No study locations are listed for this record.
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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