Trial Outcomes & Findings for Phase 3 Study of Zevalin Following R-CVP in Previously Untreated Patients With Follicular Non Hodgkin's Lymphoma (NHL) (NCT NCT00384111)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

26 participants

Primary outcome timeframe

18 months

Results posted on

2022-01-14

Participant Flow

It was planned to randomized the enrolled subjects to receive R-CVP followed by Zevalin Therapeutic Regimen or R-CVP. However, due to low enrollment and early termination, participants were not randomized and received any treatment. The data for the Participant flow and Baseline sections is reported for all enrolled participants in one arm.

Participant milestones

Participant milestones
Measure	All Enrolled Participants Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study.
Overall Study STARTED	26
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Reasons for withdrawal
Measure	All Enrolled Participants Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study.
Overall Study Disease Progression	3
Overall Study Adverse Event	1
Overall Study Investigator Decision	3
Overall Study Study Terminated by the Sponsor	19

Baseline Characteristics

Phase 3 Study of Zevalin Following R-CVP in Previously Untreated Patients With Follicular Non Hodgkin's Lymphoma (NHL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled Participants n=26 Participants Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study.
Age, Continuous	63 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Population: Data for this outcome measure was not collected and summarized as the study was terminated early by the sponsor.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Population: Data for this outcome measure was not collected and summarized as the study was terminated early by the sponsor.

Outcome measures

Outcome data not reported

Adverse Events

All Enrolled Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gajanan Bhat

Spectrum Pharmaceuticals, Inc, Research and Development Office 157 Technology Drive Irvine, CA 92618

Phone: 949-743-9219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place