Trial Outcomes & Findings for Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma (NCT NCT00110149)

NCT ID: NCT00110149

Last Updated: 2017-11-21

Results Overview

INTERNATIONAL WORKSHOP RESPONSE CRITERIA FOR NON HODGKIN'S LYMPHOMA Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, et al. Report of an international workshop to standardize response criteria for non Hodgkin's lymphoma. J Clin Oncol 1999;17(4):1244-53.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: 14 weeks
• Results posted on: 2017-11-21

Participant Flow

12 patients were recruited and signed consent. 3 patient were ineligible and were not treated. The total number treated is nine

Participant milestones

Measure	Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Overall Study STARTED	12
Overall Study Received Treatment	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Overall Study Physician Decision	3

Baseline Characteristics

Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Measure	Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan n=9 Participants Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 weeks

Population: The trial closed prematurely secondary to the company that produced the agent being sold to another company and the agent not being available to treat the full number of patients in this trial.

INTERNATIONAL WORKSHOP RESPONSE CRITERIA FOR NON HODGKIN'S LYMPHOMA

Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, et al. Report of an international workshop to standardize response criteria for non Hodgkin's lymphoma. J Clin Oncol 1999;17(4):1244-53.

Outcome measures

Measure	Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan n=9 Participants patient un treated NHL, who were then treated with the Rituximab and Y-90 Ibritumomab Tiuxetan.
Response Rate (Complete Response, Unconfirmed Complete Response, and Partial Response) at 12 Weeks CR	9 Participants
Response Rate (Complete Response, Unconfirmed Complete Response, and Partial Response) at 12 Weeks PR	0 Participants
Response Rate (Complete Response, Unconfirmed Complete Response, and Partial Response) at 12 Weeks PD	0 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The study was terminated early

Event = Death, second malignancy , disease progression.

Outcome measures

Measure	Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan n=9 Participants patient un treated NHL, who were then treated with the Rituximab and Y-90 Ibritumomab Tiuxetan.
EFS Progression	3 Participants
EFS alive in remission	5 Participants
EFS Second malignancy	1 Participants

Adverse Events

Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan

Serious events: 0 serious events

Other events: 4 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan n=9 participants at risk Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Blood and lymphatic system disorders neutropenia	44.4% 4/9 • Number of events 4 • 1 year

Additional Information

Robin Joyce, MD

BIDMC

Phone: 617-667-9920

Email: rjoyce@bidmc.harvard.edu

Results disclosure agreements

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