Trial Outcomes & Findings for Ibritumomab Tiuxetan for Treatment of Non-Follicular CD20+ Indolent Lymphomas (NCT NCT00493454)

Results Overview

Objective response rate (ORR) = number of participants out of all participating with Complete Response (CR) + Partial Response (PR) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. Response assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scans, every 3 months for the first year and every 6 months up to 3 years following.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Evaluation 4 weeks after administration of Zevalin up to 3 years

Results posted on

2013-05-31

Participant Flow

Recruitment Period: April 13, 2006 to November 8, 2007. All participants recruited in medical clinic at UT MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Ibritumomab Tiuxetan + Rituximab Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ibritumomab Tiuxetan + Rituximab Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Ibritumomab Tiuxetan for Treatment of Non-Follicular CD20+ Indolent Lymphomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ibritumomab Tiuxetan + Rituximab n=6 Participants Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
Age Continuous	67.5 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Evaluation 4 weeks after administration of Zevalin up to 3 years

Population: One participant did not receive treatment and was excluded from analysis.

Objective response rate (ORR) = number of participants out of all participating with Complete Response (CR) + Partial Response (PR) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. Response assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scans, every 3 months for the first year and every 6 months up to 3 years following.

Outcome measures

Outcome measures
Measure	Ibritumomab Tiuxetan + Rituximab n=5 Participants Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
Objective Response Rate	0.8 proportion of participants

Adverse Events

Ibritumomab Tiuxetan + Rituximab

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ibritumomab Tiuxetan + Rituximab n=5 participants at risk Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
Blood and lymphatic system disorders Neutropenia	20.0% 1/5 • 4 years and 4 months

Other adverse events

Other adverse events
Measure	Ibritumomab Tiuxetan + Rituximab n=5 participants at risk Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
Blood and lymphatic system disorders Thrombocytopenia	40.0% 2/5 • 4 years and 4 months
Blood and lymphatic system disorders Neutropenia	40.0% 2/5 • 4 years and 4 months
General disorders Fatigue	20.0% 1/5 • 4 years and 4 months

Additional Information

Felipe Samaniego, MD / Associate Professor

The University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place