Trial Outcomes & Findings for Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma (NCT NCT03681535)

Results Overview

Local control rate defined as the proportion of participants with absence of disease recurrence within the radiation therapy field as measured by standard of care imaging obtained per the National Comprehensive Cancer Network guidelines

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

243 participants

Primary outcome timeframe

2 years

Results posted on

2026-07-07

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Interventional Study RT to 19.5-20Gy is given after 3 cycles of rituximab containing chemotherapy. RT is administered daily, 5 days per week in 1.5-2Gy fractions (treatments). Radiation Therapy: 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 complete response and have a negative post-chemotherapy PET scan following 3 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.
Overall Study STARTED	243
Overall Study COMPLETED	243
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm Interventional Study n=243 Participants RT to 19.5-20Gy is given after 3 cycles of rituximab containing chemotherapy. RT is administered daily, 5 days per week in 1.5-2Gy fractions (treatments). Radiation Therapy: 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 complete response and have a negative post-chemotherapy PET scan following 3 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.
Age, Continuous	62.5 years STANDARD_DEVIATION 14.5 • n=243 Participants
Sex/Gender, Customized Gender · Male	115 Participants n=243 Participants
Sex/Gender, Customized Gender · Female	127 Participants n=243 Participants
Sex/Gender, Customized Gender · Not reported	1 Participants n=243 Participants
Region of Enrollment South Korea	38 participants n=243 Participants
Region of Enrollment Singapore	10 participants n=243 Participants
Region of Enrollment United States	157 participants n=243 Participants
Region of Enrollment Czechia	3 participants n=243 Participants
Region of Enrollment Japan	2 participants n=243 Participants
Region of Enrollment Italy	33 participants n=243 Participants

PRIMARY outcome

Timeframe: 2 years

Local control rate defined as the proportion of participants with absence of disease recurrence within the radiation therapy field as measured by standard of care imaging obtained per the National Comprehensive Cancer Network guidelines

Outcome measures

Outcome measures
Measure	Single Arm Interventional Study n=243 Participants RT to 19.5-20Gy is given after 3 cycles of rituximab containing chemotherapy. RT is administered daily, 5 days per week in 1.5-2Gy fractions (treatments). Radiation Therapy: 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 complete response and have a negative post-chemotherapy PET scan following 3 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.
Local Control Rate	0.9859 proportion of participants Interval 0.9701 to 1.0

SECONDARY outcome

Timeframe: 5 years

Disease-free survival (DFS) will be defined as the time from on-study to first disease progression or death due to any cause, whichever comes first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Overall survival will be defines as the time from on-study to death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

To examine patterns of failure we, we will tabulate the various ways that patients failed, up until the time of analysis. For example, these ways will include local only, local + distant, and distant only.

Outcome measures

Outcome data not reported

Adverse Events

Single Arm Interventional Study

Serious events: 25 serious events

Other events: 0 other events

Deaths: 18 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm Interventional Study n=243 participants at risk RT to 19.5-20Gy is given after 3 cycles of rituximab containing chemotherapy. RT is administered daily, 5 days per week in 1.5-2Gy fractions (treatments). Radiation Therapy: 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 complete response and have a negative post-chemotherapy PET scan following 3 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.
General disorders Secondary cancer	10.3% 25/243 • Number of events 45 • Up to 5 years Late adverse events of special interest (\>90 days from initiation of treatment) including cases of secondary malignancies, cardiac complications, hypothyroidism and other late effects of radiation therapy were collected through 5 years.
Cardiac disorders Cardiac complications	7.4% 18/243 • Number of events 28 • Up to 5 years Late adverse events of special interest (\>90 days from initiation of treatment) including cases of secondary malignancies, cardiac complications, hypothyroidism and other late effects of radiation therapy were collected through 5 years.
Endocrine disorders Hypothyroidism	6.2% 15/243 • Number of events 63 • Up to 5 years Late adverse events of special interest (\>90 days from initiation of treatment) including cases of secondary malignancies, cardiac complications, hypothyroidism and other late effects of radiation therapy were collected through 5 years.

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trials Office

Duke University Health System (DUHS)

Phone: +1 919 668 3726

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place