Trial Outcomes & Findings for Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar (NCT NCT00475332)

Last Updated: 2012-02-15

Results Overview

13 patients will be enrolled initially and followed for 3 months. If less than 10 of these patients reach a grade III or IV toxicity, then 12 more patients will be enrolled and the study will be deemed feasible. If 11 or more of the first group experience grade III/IV toxicity, the trial will stop early.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

2 yr 3 mos

Results posted on

2012-02-15

Participant Flow

This study was opened through UF's IRB-01 3/21/07 and closed 6/11/09 when the PI left UF. Two patients were enrolled in UF's Dept. of Radiation Oncology clinic.

Participant milestones

Participant milestones
Measure	Radiotherapy Followed by Bexxar All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiotherapy Followed by Bexxar n=2 Participants All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
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	1 Participants n=5 Participants
Age Continuous	58 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 yr 3 mos

Population: Two patients were enrolled and the study was terminated. No analyses were conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 yr 3 mos

Population: Two patients were enrolled and the study was terminated. No analyses were conducted.

Tumor response to treatment is measured using the RECIST criteria: Response Evaluation Criteria in Solid Tumors which defines Complete Response, Partial Response, Progressive Disease, and Stable Disease, by using tumor measurements as seen on CT or MRI

Outcome measures

Outcome data not reported

Adverse Events

Radiotherapy Followed by Bexxar

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Radiotherapy Followed by Bexxar n=2 participants at risk All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
Infections and infestations Infection with grade 4 neutrophils	50.0% 1/2 • Number of events 1 • 1 year, 9 months toxicity assessments at timepoints outlined in protocol
Blood and lymphatic system disorders Grade 4 leukopenia	50.0% 1/2 • Number of events 1 • 1 year, 9 months toxicity assessments at timepoints outlined in protocol
Blood and lymphatic system disorders Grade 4 lymphopenia	50.0% 1/2 • Number of events 1 • 1 year, 9 months toxicity assessments at timepoints outlined in protocol
Blood and lymphatic system disorders Grade 4 neutropenia	50.0% 1/2 • Number of events 1 • 1 year, 9 months toxicity assessments at timepoints outlined in protocol
Blood and lymphatic system disorders Grade 3 Thrombocytopenia	50.0% 1/2 • Number of events 1 • 1 year, 9 months toxicity assessments at timepoints outlined in protocol

Other adverse events

Other adverse events
Measure	Radiotherapy Followed by Bexxar n=2 participants at risk All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
Blood and lymphatic system disorders anemia grade 1	50.0% 1/2 • Number of events 1 • 1 year, 9 months toxicity assessments at timepoints outlined in protocol
Gastrointestinal disorders Diarrhea	50.0% 1/2 • Number of events 1 • 1 year, 9 months toxicity assessments at timepoints outlined in protocol
Investigations fatigue	50.0% 1/2 • Number of events 1 • 1 year, 9 months toxicity assessments at timepoints outlined in protocol
Investigations headache	50.0% 1/2 • Number of events 1 • 1 year, 9 months toxicity assessments at timepoints outlined in protocol
Blood and lymphatic system disorders grade 1 low platelet	50.0% 1/2 • Number of events 1 • 1 year, 9 months toxicity assessments at timepoints outlined in protocol
Blood and lymphatic system disorders grade 1 lymphopenia	50.0% 1/2 • Number of events 1 • 1 year, 9 months toxicity assessments at timepoints outlined in protocol
Gastrointestinal disorders mucositis	50.0% 1/2 • Number of events 1 • 1 year, 9 months toxicity assessments at timepoints outlined in protocol
Gastrointestinal disorders nausea	50.0% 1/2 • Number of events 1 • 1 year, 9 months toxicity assessments at timepoints outlined in protocol
Investigations pain	50.0% 1/2 • Number of events 1 • 1 year, 9 months toxicity assessments at timepoints outlined in protocol
Gastrointestinal disorders vomiting	50.0% 1/2 • Number of events 1 • 1 year, 9 months toxicity assessments at timepoints outlined in protocol

Additional Information

Bridget Fitzgerald, Clinical trials coordinator

University of Florida

Phone: (352) 265-0680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place