N/A
N=63
Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma
Diffuse Large B-cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01186978 ↗Enrolled (actual)
63
Serious AEs
6.4%
Results posted
Jun 2020
Primary outcome: Primary: Number of Participants With Local Control — 61 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Local Control |
61 | — |
| SECONDARY Percentage of Participants With Progression-free Survival at 5 Years |
83 | — |
| SECONDARY Percentage of Participants With Overall Survival |
90 | — |
| SECONDARY Number of Participants With Local, Distant, or Local+Distant Failure |
1; 6; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01186978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.