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Phase 2 Completed N=12 Treatment

Safety and Efficacy Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma

Hodgkin's Disease
Source: ClinicalTrials.gov NCT00484874 ↗
Enrolled (actual)
12
Serious AEs
33.3%
Results posted
Aug 2018
Primary outcomePrimary: Non-myeloablative Maximum Tolerated Dose of I-131 Tositumomab That Can be Given to Patients With Relapsed/Refractory Hodgkin's Lymphoma. — 79 cGy

Summary

The purpose of this study is to find the highest safe dose of Iodine-131 Tositumomab (Bexxar®) that can be given to patients who have relapsed/refractory Hodgkin's lymphoma, what side effects these patients get when they take Bexxar® and if Bexxar® is effective in treating relapsed/refractory Hodgkin's lymphoma. Bexxar® works by delivering doses of radiation to cancer cells.

Outcome Measures

OutcomeResultp-value
PRIMARY
Non-myeloablative Maximum Tolerated Dose of I-131 Tositumomab That Can be Given to Patients With Relapsed/Refractory Hodgkin's Lymphoma.
79
PRIMARY
Overall and Complete Response Rates
25; 25
SECONDARY
Median Time to Progression Following I-131 Tositumomab Therapy.
12
SECONDARY
Frequency of Visualization of Hodgkin's Lymphoma With I-131 Tositumomab Imaging and Tumor Radiation Absorbed Dose
100

Eligibility Criteria

Inclusion Criteria

  • Biopsy-proven Hodgkin's lymphoma that is relapsed or refractory and the patient has previously had a transplant or is ineligible for transplant
  • All stages and histologic subtypes of Hodgkin's lymphoma
  • Malignant cells may be CD20+ or CD20-
  • May have previously had either a non-myeloablative or myeloablative allogeneic or autologous stem cell transplant
  • If prior history of greater than 1 transplant, eligible if other entry criteria are met
  • No upper limit on the amount of prior chemotherapy
  • Must be at least 4 weeks out from their most recent chemotherapy or radiation therapy, 6 weeks if the last regimen included BCNU, or mitomycin
  • Age 18 or greater
  • Karnofsky performance status ≥ 60
  • Organ and marrow function within 4 weeks of registration on the protocol as defined below:
  • Leukocytes >2,000/mm3
  • Absolute neutrophil count >1,000/ mm3
  • Platelets >75,000/ mm3
  • Hemoglobin >7 g/dL
  • Creatinine <2.5 mg/dL
  • Less than 25% bone marrow involvement with Hodgkin's lymphoma within 4 weeks of registration on the protocol
  • If female, not pregnant or breast feeding
  • Ability to understand and the willingness to sign a written informed consent document
  • At least one measurable target lesion, measuring 1.5 cm in at least one dimension by standard CT imaging which is FDG -avid on PET/CT.
  • 2-year expected survival from other diseases

Exclusion Criteria

  • Receiving any other investigational agents at the same time
  • Hypocellular bone marrow (less than or equal to 10% cellularity) or marked decrease in any one (or more) hematopoietic precursor within 4 weeks of registration on the protocol
  • Inability to follow basic radiation safety precautions
  • Active infections requiring intravenous antibiotics until after resolution of the infection
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00484874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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