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
| 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
| 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
| 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 yearstumor absorbed dose (Gy)
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
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place