Trial Outcomes & Findings for Y 90 Ibritumomab Tiuxetan &Rituximab Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma (NCT NCT00073957)

Results Overview

Definition Nodal Masses Spleen, Liver Bone Marrow CR Disappearance of all evidence of disease Partial response Regression and no new sites ≥ 50% decrease in sum of the perpendicular dimension of up to 6 largest dominant masses; no increase in size of other nodes Stable disease Failure to attain CR/PR or Progressive disease or Relapsed disease : the appearance of any new lesion or the (a) FDG-avid or PET positive prior to therapy; PET positive at prior sites of disease and no new sites on CT or PET Any new lesion or increase by ≥ 50% of previously involved sites from nadir Appearance of a new lesion(s) \> 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥ 50% increase in longest diameter of a previously identified node \> 1 cm in short axis \> 50% increase from nadir in the SPD of any previous lesions New or recurrent involvement Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Y 90 Ibritumomab Tiuxetan &Rituximab Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab n=25 Participants Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Definition Nodal Masses Spleen, Liver Bone Marrow CR Disappearance of all evidence of disease Partial response Regression and no new sites ≥ 50% decrease in sum of the perpendicular dimension of up to 6 largest dominant masses; no increase in size of other nodes Stable disease Failure to attain CR/PR or Progressive disease or Relapsed disease : the appearance of any new lesion or the (a) FDG-avid or PET positive prior to therapy; PET positive at prior sites of disease and no new sites on CT or PET Any new lesion or increase by ≥ 50% of previously involved sites from nadir Appearance of a new lesion(s) \> 1.5 cm in any axis, ≥ 50% increase in SPD of more than one node, or ≥ 50% increase in longest diameter of a previously identified node \> 1 cm in short axis \> 50% increase from nadir in the SPD of any previous lesions New or recurrent involvement Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy

Outcome measures

Outcome measures
Measure	Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab n=25 Participants Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab
Response Rate = Complete and Partial Response at 12 Weeks. CR	5 participants
Response Rate = Complete and Partial Response at 12 Weeks. PR	3 participants
Response Rate = Complete and Partial Response at 12 Weeks. SD	2 participants
Response Rate = Complete and Partial Response at 12 Weeks. PD	15 participants

PRIMARY outcome

Timeframe: 12 months

This data is the best overall response achieved by patients by the 12 month period.

Outcome measures

Outcome measures
Measure	Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab n=25 Participants Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab
Best Response CR	8 Participants
Best Response PR	1 Participants
Best Response SD	1 Participants
Best Response PD	15 Participants

SECONDARY outcome

Timeframe: 12 months

the median time point at which a participants experienced and event or toxicity or progression

Outcome measures

Outcome measures
Measure	Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab n=25 Participants Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab
Event Free Survival	2.5 months Interval 1.0 to 12.0

Adverse Events

Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab n=25 participants at risk Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab
Investigations Thrombocytopenia	68.0% 17/25 • Number of events 17

Additional Information

Robin Joyce, MD

Beth Israel Deaconess Medical Center

Phone: 617-667-9920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place