Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy

Phase 2

Terminated

• Conditions: Lymphoma, Non-Hodgkin
• Interventions: Drug: Bexxar (tositumomab); Procedure: External beam radiotherapy (XRT); Drug: Potassium Iodide (KI)

• Registration Number: NCT00490490
• Lead Sponsor: Stanford University

Brief Summary

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).

Detailed Description

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

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-06-20
• Study First Submitted QC: 2007-06-20
• Study First Posted: 2007-06-22
• Primary Completion: 2011-06
• Study Completion: 2013-07
• Results First Submitted: 2016-12-19
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-09
• Last Update Submitted: 2017-02-09
• Results First Posted: 2017-03-29
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tositumomab + XRT + KI	Bexxar (tositumomab)	Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
Tositumomab + XRT + KI	Potassium Iodide (KI)	Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
Tositumomab + XRT + KI	External beam radiotherapy (XRT)	Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)

Primary Outcome Measures

Name	Time	Method
Complete Response (CR) Rate	12 weeks	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

Secondary Outcome Measures

Name	Time	Method
Time-to-Progression (TTP)	2 years
Overall Response Rate (ORR)	12 weeks	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

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States