A Phase 2 interventional study of Bexxar (tositumomab) and External beam radiotherapy (XRT) in Lymphoma, Non-Hodgkin, sponsored by Stanford University. Terminated at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2017-03-29.
Sponsored by Stanford University · Phase 2, Interventional, and Treatment
The purpose of the study is to assess the response rate of patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma to Iodine-131 (I-131) tositumomab (Bexxar) therapy plus local palliative radiation therapy (XRT).
Response will be assessed on the basis of the presence or absence of measurable lesion ≥ 1.4 x 1.4 cm (operationally defined as ≥ 2.0 cm2) by radiographic evaluation OR ≥ 1.0 cm in greatest diameter detected by palpation on physical exam
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 8 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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EXCLUSION CRITERIA
Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
Drug: Bexxar (tositumomab) · Procedure: External beam radiotherapy (XRT) · Drug: Potassium Iodide (KI)
Tositumomab is a CD20-directed radiotherapeutic (131-iodine) monoclonal antibody indicated for the treatment of patients with CD20-positive, relapsed or refractory, low-grade, follicular, or transformed non-Hodgkin's lymphoma who have progressed during or after rituximab therapy, including patients with rituximab-refractory non-Hodgkin's lymphoma. Tositumomab (standard regimen) will be administered at whole body exposure of 75 cGy.
Also known as: 131-iodine tositumomab
Patient-specific XRT will begin within 24 hours of administration of the therapeutic dose of tositumomab. Subjects will receive local XRT to bulky sites of disease measuring at least 5 cm in at least one dimension. The size and number of fields to be treated will determined by the investigators, but will encompass the patient's most symptomatic/threatening site(s) of disease and not cumulatively include more than 25% of the active bone marrow. Subjects will be treated with the 2 x 2 Gy regimen (2 daily fractions of 2 Gy). Sites of disease previously-irradiated with 30 to 40 Gy will not be treated on this study.
Also known as: Radiotherapy (RT)
Potassium iodide (KI) will be administered as: * Saturated solution potassium iodide (SSKI) 4 drops orally 3-times-a-day, * Lugol's solution 20 drops orally 3-times-a-day, OR * KI tablets 130 mg orally once per day KI treatment will start at least 24 hours prior to tositumomab, and continue daily for 14 days following the last dose of tositumomab
Also known as: Saturated Solution Potassium Iodide (SSKI), Lugol's solution, Potassium iodide tablets
Complete Response (CR) Rate
Participants assessed for by the following Complete Response (CR) criteria CR or Functional CR * No evidence of disease and symptoms * Any macroscopic nodules detected in any organs no longer present. * Any palpable lymph node is normal and greatest diameter is \< 1.0 cm. * The enlarged organs decreased in size and not palpable * The bone marrow biopsy and aspirate are negative for disease * Negative for disease by PET-scan (functional CR) CR Unconfirmed (CRu) criteria * No evidence of disease and symptoms * Any lymph node mass \> 1.0 cm\^2 diameter has regressed is size by more than 75%. * No macroscopic nodules in any organs * Any palpable lymph node is normal and greatest diameter is \< 1.0 cm. * The bone marrow biopsy and aspirate are negative for disease * The bone marrow biopsy may have increased number or size of lymphoid aggregates without cytologic or architectural atypia
Time frame: 12 weeks
Overall Response Rate (ORR)
ORR is assessed as the sum of the overall rates of * CR confirmed by positron emission tomography (PET) * CR not confirmed by PET, and * Partial response (PR) negative for progression by PET
Time frame: 12 weeks
Time-to-Progression (TTP)
Time frame: 2 years
| Milestone | Tositumomab + XRT + KI |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
| Milestone | Tositumomab + XRT + KI |
|---|---|
| Started | 8 |
| Completed | 5 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lost to follow-up | 2 |
Participants assessed for by the following Complete Response (CR) criteria CR or Functional CR * No evidence of disease and symptoms * Any macroscopic nodules detected in any organs no longer present. * Any palpable lymph node is normal and greatest diameter is \< 1.0 cm. * The enlarged organs decreased in size and not palpable * The bone marrow biopsy and aspirate are negative for disease * Negative for disease by PET-scan (functional CR) CR Unconfirmed (CRu) criteria * No evidence of disease and symptoms * Any lymph node mass \> 1.0 cm\^2 diameter has regressed is size by more than 75%. * No macroscopic nodules in any organs * Any palpable lymph node is normal and greatest diameter is \< 1.0 cm. * The bone marrow biopsy and aspirate are negative for disease * The bone marrow biopsy may have increased number or size of lymphoid aggregates without cytologic or architectural atypia
| percentage of participants | Tositumomab + XRT + KI |
|---|---|
| CR | 37.5 |
| Partial response (PR) or stable disease (SD) | 62.5 |
ORR is assessed as the sum of the overall rates of * CR confirmed by positron emission tomography (PET) * CR not confirmed by PET, and * Partial response (PR) negative for progression by PET
| percentage of participants | Tositumomab + XRT + KI |
|---|---|
| All CR + PR | 50 |
| Partial Response (PR) | 12.5 |
| Stable Disease (SD) | 50 |
| Progressive disease (PD) | 0 |
| Participants | Tositumomab + XRT + KI |
|---|---|
| 3 months | 1 |
| 6 months | 1 |
| 9 months | 1 |
| 18 months | 2 |
| 60 months | 1 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tositumomab + XRT + KI | — | 8/8 (100%) | 8/8 (100%) |
| Event | Tositumomab + XRT + KI |
|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 8/8 |
| NeutropeniaBlood and lymphatic system disorders | 4/8 |
| AnemiaBlood and lymphatic system disorders | 3/8 |
| Event | Tositumomab + XRT + KI |
|---|---|
| AnemiaBlood and lymphatic system disorders | 8/8 |
| ThrombocytoperiaBlood and lymphatic system disorders | 8/8 |
| LeukocytopeniaBlood and lymphatic system disorders | 8/8 |
| HeadachesNervous system disorders | 8/8 |
| NeutropeniaBlood and lymphatic system disorders | 7/8 |
| NauseaGastrointestinal disorders | 5/8 |
| FatigueGeneral disorders | 5/8 |
| HeadachesNervous system disorders | 5/8 |
| Back PainMusculoskeletal and connective tissue disorders | 3/8 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/8 |
| Age, Categorical(Participants) | Tositumomab + XRT + KI |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 3 |
| Sex: Female, Male(Participants) | Tositumomab + XRT + KI |
|---|---|
| Female | 2 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Tositumomab + XRT + KI |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Tositumomab + XRT + KI |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Histology(Participants) | Tositumomab + XRT + KI |
|---|---|
| Follicular Lymphoma, Grade 1 | 2 |
| Follicular Lymphoma, Grade 2 | 2 |
| Follicular Lymphoma, Grade 3 | 2 |
| Marginal Zone B-Cell Lymphoma | 2 |
This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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