Trial Outcomes & Findings for Safety and Efficacy Study of I-131 Tositumomab in Patients With Relapsed/Refractory Hodgkin's Lymphoma (NCT NCT00484874)

NCT ID: NCT00484874

Last Updated: 2018-08-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2018-08-01

Participant Flow

Participant milestones

Measure	A Single Dose of I-131 Tositumomab I-131 Tositumomab therapeutic regimen given to patients with relapsed/refractory Hodgkin's lymphoma who have or have not undergone transplant.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	A Single Dose of I-131 Tositumomab n=12 Participants I-131 Tositumomab therapeutic regimen given to patients with relapsed/refractory Hodgkin's lymphoma who have or have not undergone transplant.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	36 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Post-transplant	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Measure	A Single Dose of I-131 Tositumomab n=12 Participants Non-myeloablative maximum tolerated dose of I-131 Tositumomab that can be given to patients with relapsed/refractory Hodgkin's lymphoma. I-131 Tositumomab therapeutic regimen: Tositumomab and I-131 tositumomab are given intravenously. A test dose is given followed by a larger treatment dose.
Non-myeloablative Maximum Tolerated Dose of I-131 Tositumomab That Can be Given to Patients With Relapsed/Refractory Hodgkin's Lymphoma.	79 cGy

PRIMARY outcome

Timeframe: 12 weeks post therapy

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CTI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure	A Single Dose of I-131 Tositumomab n=12 Participants Non-myeloablative maximum tolerated dose of I-131 Tositumomab that can be given to patients with relapsed/refractory Hodgkin's lymphoma. I-131 Tositumomab therapeutic regimen: Tositumomab and I-131 tositumomab are given intravenously. A test dose is given followed by a larger treatment dose.
Overall and Complete Response Rates ORR	25 percentage of participants
Overall and Complete Response Rates CRR	25 percentage of participants

SECONDARY outcome

Timeframe: From time measurement criteria are met for response until first date that recurrent or progressive disease is objectively documented, assessed up to 5 years.

Outcome measures

Measure	A Single Dose of I-131 Tositumomab n=12 Participants Non-myeloablative maximum tolerated dose of I-131 Tositumomab that can be given to patients with relapsed/refractory Hodgkin's lymphoma. I-131 Tositumomab therapeutic regimen: Tositumomab and I-131 tositumomab are given intravenously. A test dose is given followed by a larger treatment dose.
Median Time to Progression Following I-131 Tositumomab Therapy.	12 weeks Standard Deviation 3.3

SECONDARY outcome

Timeframe: up to 1 week post-intervention

Percentage of participants with visualized I-131 uptake.

Outcome measures

Measure	A Single Dose of I-131 Tositumomab n=12 Participants Non-myeloablative maximum tolerated dose of I-131 Tositumomab that can be given to patients with relapsed/refractory Hodgkin's lymphoma. I-131 Tositumomab therapeutic regimen: Tositumomab and I-131 tositumomab are given intravenously. A test dose is given followed by a larger treatment dose.
Frequency of Visualization of Hodgkin's Lymphoma With I-131 Tositumomab Imaging and Tumor Radiation Absorbed Dose	100 Percentage of patients with I-131 uptake

Adverse Events

A Single Dose of I-131 Tositumomab

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	A Single Dose of I-131 Tositumomab n=12 participants at risk I-131 Tositumomab therapeutic regimen given to patients with relapsed/refractory Hodgkin's lymphoma who have or have not undergone transplant.
Investigations Hemoglobin Decreased	16.7% 2/12 • Adverse events were collected up to 2 years following the administration of I-131 Tositumomab.
Blood and lymphatic system disorders Anemia	33.3% 4/12 • Adverse events were collected up to 2 years following the administration of I-131 Tositumomab.
Investigations Platelet Count Decreased	33.3% 4/12 • Adverse events were collected up to 2 years following the administration of I-131 Tositumomab.

Other adverse events

Measure	A Single Dose of I-131 Tositumomab n=12 participants at risk I-131 Tositumomab therapeutic regimen given to patients with relapsed/refractory Hodgkin's lymphoma who have or have not undergone transplant.
Investigations Hemoglobin Decreased	50.0% 6/12 • Adverse events were collected up to 2 years following the administration of I-131 Tositumomab.
Blood and lymphatic system disorders Anemia	8.3% 1/12 • Adverse events were collected up to 2 years following the administration of I-131 Tositumomab.
Investigations Platelet Count Decreased	50.0% 6/12 • Adverse events were collected up to 2 years following the administration of I-131 Tositumomab.
General disorders Fatigue	41.7% 5/12 • Adverse events were collected up to 2 years following the administration of I-131 Tositumomab.
Infections and infestations Lungm aero-digestive	8.3% 1/12 • Adverse events were collected up to 2 years following the administration of I-131 Tositumomab.
Endocrine disorders Hypothyroidism	16.7% 2/12 • Adverse events were collected up to 2 years following the administration of I-131 Tositumomab.
Musculoskeletal and connective tissue disorders Pain in Extremity	16.7% 2/12 • Adverse events were collected up to 2 years following the administration of I-131 Tositumomab.
General disorders Fever	8.3% 1/12 • Adverse events were collected up to 2 years following the administration of I-131 Tositumomab.
General disorders Chills	8.3% 1/12 • Adverse events were collected up to 2 years following the administration of I-131 Tositumomab.
General disorders Cold Intolerance	8.3% 1/12 • Adverse events were collected up to 2 years following the administration of I-131 Tositumomab.
Respiratory, thoracic and mediastinal disorders Pulmonary Hemorrhage	8.3% 1/12 • Adverse events were collected up to 2 years following the administration of I-131 Tositumomab.

Additional Information

Heather Jacene, MD

Dana-Farber Cancer Institute

Phone: 617-632-3767

Email: hjacene@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place