Trial Outcomes & Findings for R-ICE and High-Dose Cyclophosphamide With PET/CT for Diffuse Large B-Cell Non-Hodgkin's Lymphoma (NCT NCT00809341)
NCT ID: NCT00809341
Last Updated: 2018-09-25
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
2 years
Results posted on
2018-09-25
Participant Flow
1 participant was deemed ineligible and therefore not assigned to intervention. One participant withdrew informed consent prior to starting the study.
Participant milestones
| Measure |
PET Negative
Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status.
|
PET Positive
Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
5
|
|
Overall Study
COMPLETED
|
20
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
PET Negative
Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status.
|
PET Positive
Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
R-ICE and High-Dose Cyclophosphamide With PET/CT for Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
PET Negative
n=20 Participants
Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status.
|
PET Positive
n=5 Participants
Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
52.5 years
n=5 Participants
|
50 years
n=7 Participants
|
52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The study was placed on hold to determine a quantitative method for the evaluation of PET scan results. No decision was reached on the evaluation mechanism for the PET scans, so the study was terminated. Data for this outcome was not collected because a standardized evaluation mechanism for the PET scans was not found.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: The study was placed on hold to determine a quantitative method for the evaluation of PET scan results. No decision was reached on the evaluation mechanism for the PET scans, so the study was terminated. Data for this outcome was not collected because a standardized evaluation mechanism for the PET scans was not found.
Outcome measures
Outcome data not reported
Adverse Events
PET Negative
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
PET Positive
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PET Negative
n=20 participants at risk
Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status.
|
PET Positive
n=5 participants at risk
Patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma that have received 3 cycles of R-CHOP, or an equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH), will have a whole-body PET-CT scan performed to determine PET-positive or PET-negative status. These patients will then be assigned to a treatment arm based on the PET-positive or PET-negative status.
|
|---|---|---|
|
Infections and infestations
Febrile Neutropenia
|
0.00%
0/20 • Up to 2 years
|
40.0%
2/5 • Number of events 2 • Up to 2 years
|
|
Nervous system disorders
Hemorrhage, CNS
|
0.00%
0/20 • Up to 2 years
|
20.0%
1/5 • Number of events 1 • Up to 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lode Swinnen
Johns Hopkins Sidney Kimmel Cancer Center
Phone: 410-955-8603
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place