Diffuse Large B-cell Lymphoma
Conditions
Brief summary
This study will evaluate whether a reduction in the radiation dose and field size will maintain a high rate of local control while minimizing the risk of acute and late toxicity. Hypothesis- The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy while maintaining high rates of local control in patients who had a negative PET scan following rituximab-containing chemotherapy.
Interventions
RADIATIONRadiation Therapy
1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Histologic documentation of diffuse large B-cell lymphoma, or any of its variants as defined in the WHO classification * Completion of at least 4 cycles of a rituximab-containing, anthracycline-based combination chemotherapy * Negative post-chemotherapy (or interim) PET scan * Absolute neutrophil count greater than 1500 and platelet count greater than 40,000 * Negative pregnancy test in women of child-bearing potential For patients with HIV/AIDS, the following must be true: * The patient is compliant on combination anti-retroviral therapy (CART) * The patient has CD4 count ≥ 200 at time of diagnosis
Exclusion criteria
* Any contraindications to irradiation * Primary CNS lymphoma * HIV/AIDS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Local Control | 5 years | This trial will accrue 62 patients over a time period of approximately 5-6 years. The primary objective is to determine whether the number of participants with local control at 5 years, estimated from the Kaplan-Meier curve of time-to-local failure, is as high as that observed in historical controls, i.e., 0.90. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Progression-free Survival at 5 Years | 5 years | Progression-free survival (PFS) will be defined as the time from on-study to disease progression or death due to any cause, whichever comes first. |
| Percentage of Participants With Overall Survival | 5 years | Overall survival will be defined as the number of participants who are alive |
| Number of Participants With Local, Distant, or Local+Distant Failure | 5 years | To examine the patterns of failure, we will tabulate the various ways that patients failed up until the time of the analysis. For example, these ways will include local only, local + distant, and distant only. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity.
Radiation Therapy: 1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 58 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 52 Participants |
| Region of Enrollment United States | 63 Participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 63 |
| other Total, other adverse events | 16 / 63 |
| serious Total, serious adverse events | 4 / 63 |
Outcome results
Primary
Number of Participants With Local Control
This trial will accrue 62 patients over a time period of approximately 5-6 years. The primary objective is to determine whether the number of participants with local control at 5 years, estimated from the Kaplan-Meier curve of time-to-local failure, is as high as that observed in historical controls, i.e., 0.90.
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Number of Participants With Local Control | 61 Participants |
Secondary
Number of Participants With Local, Distant, or Local+Distant Failure
To examine the patterns of failure, we will tabulate the various ways that patients failed up until the time of the analysis. For example, these ways will include local only, local + distant, and distant only.
Time frame: 5 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | Number of Participants With Local, Distant, or Local+Distant Failure | Local failure | 1 Participants |
| Single Arm | Number of Participants With Local, Distant, or Local+Distant Failure | Distant failure | 6 Participants |
| Single Arm | Number of Participants With Local, Distant, or Local+Distant Failure | Local+distant failure | 0 Participants |
Secondary
Percentage of Participants With Overall Survival
Overall survival will be defined as the number of participants who are alive
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Percentage of Participants With Overall Survival | 90 percentage of participants |
Secondary
Percentage of Participants With Progression-free Survival at 5 Years
Progression-free survival (PFS) will be defined as the time from on-study to disease progression or death due to any cause, whichever comes first.
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Percentage of Participants With Progression-free Survival at 5 Years | 83 percentage of participants |