Trial Outcomes & Findings for Iodine I 131 Tositumomab or Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma (NCT NCT00416312)

NCT ID: NCT00416312

Last Updated: 2018-08-27

Results Overview

tumor absorbed dose (Gy)

Recruitment status

COMPLETED

Target enrollment

9 participants

Primary outcome timeframe

up to 4 years

Results posted on

2018-08-27

Participant Flow

All NHL patients treated by either Bexxar or Zevalin

Participant milestones

Participant milestones
Measure
Conventional & Patient-specific Dosimetry
Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.
Overall Study
STARTED
9
Overall Study
Conventional Dosimetry
9
Overall Study
Patient-specific Dosimetry
9
Overall Study
COMPLETED
7
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Conventional & Patient-specific Dosimetry
Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.
Overall Study
tumors not visible on imaging
2

Baseline Characteristics

Tumors could not be detected on imaging for 2 of the 9 enrolled patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Conventional & Patient-specific Dosimetry
n=9 Participants
Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.
Age, Categorical
<=18 years
0 Participants
n=7 Participants • Tumors could not be detected on imaging for 2 of the 9 enrolled patients
Age, Categorical
Between 18 and 65 years
1 Participants
n=7 Participants • Tumors could not be detected on imaging for 2 of the 9 enrolled patients
Age, Categorical
>=65 years
6 Participants
n=7 Participants • Tumors could not be detected on imaging for 2 of the 9 enrolled patients
Sex: Female, Male
Female
1 Participants
n=7 Participants • Tumors could not be detected on imaging for 2 of the 9 enrolled patients
Sex: Female, Male
Male
6 Participants
n=7 Participants • Tumors could not be detected on imaging for 2 of the 9 enrolled patients

PRIMARY outcome

Timeframe: up to 4 years

tumor absorbed dose (Gy)

Outcome measures

Outcome measures
Measure
Conventional & Patient-specific Dosimetry
n=7 tumor
Tumor absorbed dose calculations determined using both conventional dosimetry and 3D-RD patient-specific dosimetry software.
Tumor Absorbed Dose
Conventional dosimetry
3.01 Gy
Standard Deviation 3.04
Tumor Absorbed Dose
Patient-specific dosimetry
3.41 Gy
Standard Deviation 3.1

Adverse Events

Conventional & Patient-specific Dosimetry

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

George Sgouros, Ph.D.

Johns Hopkins University, School of Medicine

Phone: 410 614 0116

Results disclosure agreements

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