Trial Outcomes & Findings for Rituximab With or Without Yttrium Y-90 Ibritumomab Tiuxetan in Treating Patients With Untreated Follicular Lymphoma (NCT NCT02320292)

NCT ID: NCT02320292

Last Updated: 2025-07-09

Results Overview

Will be compared between the two arms. The percentage of patients in each response category (e.g., CR, partial remission, stable disease, relapse/progressive disease) will also be tabulated by arm. The proportion of patients who have a CR at 6 months will be evaluated and compared between the two treatment regimens using a two-sided alpha=0.05 continuity corrected Cochran-Mantel-Haenszel test with stratification factors.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

20 participants

Primary outcome timeframe

6 months

Results posted on

2025-07-09

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A (Rituximab) Patients receive rituximab IV on days 1, 8, 15, and 22.\> \> Quality-of-Life Assessment: Ancillary studies\> \> Rituximab: Given IV	Arm B (Rituximab, Yttrium Y-90 Ibritumomab Tiuxetan) Patients receive rituximab IV on days 1 and 8 and yttrium Y-90 ibritumomab tiuxetan over 10 minutes on day 8.\> \> Quality-of-Life Assessment: Ancillary studies\> \> Rituximab: Given IV\> \> Yttrium Y-90 Ibritumomab Tiuxetan: Given IV
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rituximab With or Without Yttrium Y-90 Ibritumomab Tiuxetan in Treating Patients With Untreated Follicular Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (Rituximab) n=10 Participants Patients receive rituximab IV on days 1, 8, 15, and 22.\> \> Quality-of-Life Assessment: Ancillary studies\> \> Rituximab: Given IV	Arm B (Rituximab, Yttrium Y-90 Ibritumomab Tiuxetan) n=10 Participants Patients receive rituximab IV on days 1 and 8 and yttrium Y-90 ibritumomab tiuxetan over 10 minutes on day 8.\> \> Quality-of-Life Assessment: Ancillary studies\> \> Rituximab: Given IV\> \> Yttrium Y-90 Ibritumomab Tiuxetan: Given IV	Total n=20 Participants Total of all reporting groups
Age, Continuous	61.0 years n=5 Participants	59.0 years n=7 Participants	60.5 years n=5 Participants
Age, Customized 18-29	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized 30-39	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized 40-49	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Age, Customized 50-59	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Age, Customized 60-69	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Age, Customized 70+	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Beta-2 Microglobulin Normal	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Beta-2 Microglobulin Abnormal	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Time from Diagnosis to Registration < 3 months	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Time from Diagnosis to Registration 3-12 months	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Lactate Dehydrongenase Normal	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Lactate Dehydrongenase Abnormal	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
NHL Type Follicular Lymp Grade 1	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
NHL Type Follicular Lymp Grade 2	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
FLIPI2 score Low Risk	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
FLIPI2 score Intermediate Risk	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
FLIPI2 score High Risk	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Arm A (Rituximab) n=10 Participants Patients receive rituximab IV on days 1, 8, 15, and 22.\> \> Quality-of-Life Assessment: Ancillary studies\> \> Rituximab: Given IV	Arm B (Rituximab, Yttrium Y-90 Ibritumomab Tiuxetan) n=10 Participants Patients receive rituximab IV on days 1 and 8 and yttrium Y-90 ibritumomab tiuxetan over 10 minutes on day 8.\> \> Quality-of-Life Assessment: Ancillary studies\> \> Rituximab: Given IV\> \> Yttrium Y-90 Ibritumomab Tiuxetan: Given IV
Complete Response (CR) Rate at the 6-month Disease Assessment CR	3 Participants	6 Participants
Complete Response (CR) Rate at the 6-month Disease Assessment PR	6 Participants	2 Participants
Complete Response (CR) Rate at the 6-month Disease Assessment SD	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Time from registration to the earliest date documentation of disease progression or death due to any cause, assessed up to 5 years

The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier within each arm and compared between the arms using a logrank test. The progression-free survival rates at 3 years and 5 years will be estimated in each arm.

Outcome measures

Outcome measures
Measure	Arm A (Rituximab) n=10 Participants Patients receive rituximab IV on days 1, 8, 15, and 22.\> \> Quality-of-Life Assessment: Ancillary studies\> \> Rituximab: Given IV	Arm B (Rituximab, Yttrium Y-90 Ibritumomab Tiuxetan) n=10 Participants Patients receive rituximab IV on days 1 and 8 and yttrium Y-90 ibritumomab tiuxetan over 10 minutes on day 8.\> \> Quality-of-Life Assessment: Ancillary studies\> \> Rituximab: Given IV\> \> Yttrium Y-90 Ibritumomab Tiuxetan: Given IV
Progression-free Survival (PFS)	NA months Interval 23.9 to Not enough events to calculate median PFS	29.9 months Interval 25.6 to Not enough events to calculate median PFS

SECONDARY outcome

Timeframe: Time from registration to the date of initiation of any treatment for follicular lymphoma, assessed up to 5 years

The distribution of time to any therapy will be estimated using the method of Kaplan-Meier within each arm and compared between the arms using a log-rank test. The percentage of patients free of any therapy at 3 years and 5 years will be estimated in each arm.

Outcome measures

Outcome measures
Measure	Arm A (Rituximab) n=10 Participants Patients receive rituximab IV on days 1, 8, 15, and 22.\> \> Quality-of-Life Assessment: Ancillary studies\> \> Rituximab: Given IV	Arm B (Rituximab, Yttrium Y-90 Ibritumomab Tiuxetan) n=10 Participants Patients receive rituximab IV on days 1 and 8 and yttrium Y-90 ibritumomab tiuxetan over 10 minutes on day 8.\> \> Quality-of-Life Assessment: Ancillary studies\> \> Rituximab: Given IV\> \> Yttrium Y-90 Ibritumomab Tiuxetan: Given IV
Time to Any Therapy (TTNT)	NA months Interval 47.6 to Not enough events to calculate median TTNT	59.6 months Interval 36.1 to Not enough events to calculate median TTNT

SECONDARY outcome

Timeframe: Time from registration to the date of initiation of chemotherapy for follicular lymphoma, assessed up to 5 years

The distribution of time to chemotherapy will be estimated using the method of Kaplan-Meier within each arm and compared between the arms using a log-rank test. The percentage of patients free of chemotherapy at 3 years and 5 years will be estimated in each arm.

Outcome measures

Outcome measures
Measure	Arm A (Rituximab) n=10 Participants Patients receive rituximab IV on days 1, 8, 15, and 22.\> \> Quality-of-Life Assessment: Ancillary studies\> \> Rituximab: Given IV	Arm B (Rituximab, Yttrium Y-90 Ibritumomab Tiuxetan) n=10 Participants Patients receive rituximab IV on days 1 and 8 and yttrium Y-90 ibritumomab tiuxetan over 10 minutes on day 8.\> \> Quality-of-Life Assessment: Ancillary studies\> \> Rituximab: Given IV\> \> Yttrium Y-90 Ibritumomab Tiuxetan: Given IV
Time to Chemotherapy (TTC)	NA months Not enough events to calculate median TTC	NA months Interval 59.6 to Not enough events to calculate median TTC

SECONDARY outcome

Timeframe: Up to 5 years

Assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Rates of individual adverse events (grade 3 and higher) will be compared between arms using a Fisher's exact test.

Outcome measures

Outcome measures
Measure	Arm A (Rituximab) n=10 Participants Patients receive rituximab IV on days 1, 8, 15, and 22.\> \> Quality-of-Life Assessment: Ancillary studies\> \> Rituximab: Given IV	Arm B (Rituximab, Yttrium Y-90 Ibritumomab Tiuxetan) n=10 Participants Patients receive rituximab IV on days 1 and 8 and yttrium Y-90 ibritumomab tiuxetan over 10 minutes on day 8.\> \> Quality-of-Life Assessment: Ancillary studies\> \> Rituximab: Given IV\> \> Yttrium Y-90 Ibritumomab Tiuxetan: Given IV
Incidence of Adverse Events Grade 3+ Adverse Event	0 Participants	5 Participants
Incidence of Adverse Events Grade 4+ Adverse Event	0 Participants	1 Participants
Incidence of Adverse Events Grade 3+ Hem Adverse Event	0 Participants	5 Participants
Incidence of Adverse Events Grade 4+ Hem Adverse Event	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Will be evaluated in each arm independently and may also be compared between the two arms. Values may be investigated with respect to response (CR vs. less than CR) chi-square tests. Relationship with time to event measures (PFS, TTNT, TTC) will be evaluated using Kaplan-Meier methods and log-rank statistics (categorical measures).

Outcome measures

Outcome data not reported

Timeframe: Baseline to 6 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

As assessed by Functional Assessment of Cancer Therapy (FACT). Mean FACT will be graphically presented by arm using a mean plot with standard deviation error bars including all available data with patients according to the randomized treatment assignment. Baseline characteristics will be compared between arms within the subject of patients who provide QOL data at one or more time points using t-tests for continuous variables and chi-squared tests for categorical variables.

Outcome measures

Outcome data not reported

Adverse Events

Arm A (Rituximab)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm B (Rituximab, Yttrium Y-90 Ibritumomab Tiuxetan)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A (Rituximab) n=10 participants at risk Rituximab: Given IV	Arm B (Rituximab, Yttrium Y-90 Ibritumomab Tiuxetan) n=10 participants at risk Yttrium Y-90 Ibritumomab Tiuxetan: Given IV
Investigations Neutrophil count decreased	0.00% 0/10 • Up to 5 years	10.0% 1/10 • Number of events 1 • Up to 5 years
Investigations Platelet count decreased	0.00% 0/10 • Up to 5 years	10.0% 1/10 • Number of events 1 • Up to 5 years

Other adverse events

Other adverse events
Measure	Arm A (Rituximab) n=10 participants at risk Rituximab: Given IV	Arm B (Rituximab, Yttrium Y-90 Ibritumomab Tiuxetan) n=10 participants at risk Yttrium Y-90 Ibritumomab Tiuxetan: Given IV
Blood and lymphatic system disorders Anemia	0.00% 0/10 • Up to 5 years	30.0% 3/10 • Number of events 4 • Up to 5 years
General disorders Fatigue	10.0% 1/10 • Number of events 1 • Up to 5 years	0.00% 0/10 • Up to 5 years
Infections and infestations Infections and infestations - Oth spec	0.00% 0/10 • Up to 5 years	10.0% 1/10 • Number of events 1 • Up to 5 years
Infections and infestations Upper respiratory infection	0.00% 0/10 • Up to 5 years	10.0% 1/10 • Number of events 1 • Up to 5 years
Investigations Lymphocyte count decreased	0.00% 0/10 • Up to 5 years	30.0% 3/10 • Number of events 4 • Up to 5 years
Investigations Neutrophil count decreased	0.00% 0/10 • Up to 5 years	60.0% 6/10 • Number of events 6 • Up to 5 years
Investigations Platelet count decreased	0.00% 0/10 • Up to 5 years	60.0% 6/10 • Number of events 6 • Up to 5 years
Investigations White blood cell decreased	0.00% 0/10 • Up to 5 years	70.0% 7/10 • Number of events 8 • Up to 5 years
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/10 • Up to 5 years	10.0% 1/10 • Number of events 1 • Up to 5 years

Additional Information

Dr. Thomas E Witzig

Mayo Clinic

Phone: 507-266-4994

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place