Trial Outcomes & Findings for Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma (NCT NCT00075946)
NCT ID: NCT00075946
Last Updated: 2024-02-01
Results Overview
TTRF is defined as the time from randomization until any one of the following criteria are met, and censored at last disease assessment for cases who have not experienced failure (with the cut-off date for final analysis of 11/1/2011): 1. No response (partial response (PR) or complete response (CR)) to rituximab retreatment (Arm A treatment). 2. Time to progression \< 26 weeks from day 1 of most recent rituximab treatment. 3. Initiation of alternative therapy. 4. Inability to complete protocol therapy (due to adverse events, patient preference, or any other reason, including death).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
545 participants
Primary outcome timeframe
Assessed (by restaging CT scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as Day 1, until rituximab failure observed or July 17, 2013, whichever occurred first.
Results posted on
2024-02-01
Participant Flow
The study was opened on Nov 21, 2003, accrued its first patient on January 23, 2004, and closed on Sept 12, 2008, with final accrual of 545 patients.
Patients received induction rituximab IV once a week for 4 weeks. Patients were re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab were randomized to one of the two treatment arms, stratified on histology (follicular vs other), age, and time from diagnosis.
Participant milestones
| Measure |
Rituximab Retreatment: Follicular Patients
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Scheduled: Follicular Patients
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Retreatment: Non-Follicular Patients
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Scheduled: Non-Follicular Patients
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
|
Enrolled But Not Randomized
Patients who were enrolled in the study but not proceed to randomization. These could include patients with undetermined histology as well as those who did not achieve response (PR or CR) after induction rituximab.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
148
|
151
|
28
|
30
|
188
|
|
Overall Study
Treated and With Toxicity Data Available
|
142
|
148
|
27
|
29
|
154
|
|
Overall Study
Included in Primary Analysis
|
143
|
146
|
23
|
29
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
148
|
151
|
28
|
30
|
188
|
Reasons for withdrawal
| Measure |
Rituximab Retreatment: Follicular Patients
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Scheduled: Follicular Patients
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Retreatment: Non-Follicular Patients
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Scheduled: Non-Follicular Patients
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
|
Enrolled But Not Randomized
Patients who were enrolled in the study but not proceed to randomization. These could include patients with undetermined histology as well as those who did not achieve response (PR or CR) after induction rituximab.
|
|---|---|---|---|---|---|
|
Overall Study
Path ineligible: undetermined histology
|
0
|
0
|
0
|
0
|
6
|
|
Overall Study
Did not achieve response after induction
|
0
|
0
|
0
|
0
|
182
|
|
Overall Study
Incorrectly randomized (no response)
|
5
|
5
|
5
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
10
|
0
|
2
|
0
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
23
|
58
|
4
|
9
|
0
|
|
Overall Study
Alternative therapy
|
16
|
2
|
5
|
0
|
0
|
|
Overall Study
Other complicating disease
|
7
|
13
|
1
|
4
|
0
|
|
Overall Study
No response to retreatment
|
23
|
0
|
2
|
0
|
0
|
|
Overall Study
Time to progression less than 6 months
|
15
|
30
|
8
|
3
|
0
|
|
Overall Study
Other
|
57
|
32
|
3
|
11
|
0
|
Baseline Characteristics
Rituximab in Treating Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Rituximab Retreatment: Follicular Patients
n=143 Participants
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Scheduled: Follicular Patients
n=146 Participants
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Retreatment: Non-Follicular Patients
n=23 Participants
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Scheduled: Non-Follicular Patients
n=29 Participants
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
|
Total
n=341 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
58 years
n=7 Participants
|
61 years
n=5 Participants
|
65 years
n=4 Participants
|
60 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
186 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
155 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Assessed (by restaging CT scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as Day 1, until rituximab failure observed or July 17, 2013, whichever occurred first.Population: Eligible patients who were randomized to one of the two arms for maintenance therapy.
TTRF is defined as the time from randomization until any one of the following criteria are met, and censored at last disease assessment for cases who have not experienced failure (with the cut-off date for final analysis of 11/1/2011): 1. No response (partial response (PR) or complete response (CR)) to rituximab retreatment (Arm A treatment). 2. Time to progression \< 26 weeks from day 1 of most recent rituximab treatment. 3. Initiation of alternative therapy. 4. Inability to complete protocol therapy (due to adverse events, patient preference, or any other reason, including death).
Outcome measures
| Measure |
Rituximab Retreatment: Follicular Patients
n=143 Participants
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Scheduled: Follicular Patients
n=146 Participants
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Retreatment: Non-Follicular Patients
n=23 Participants
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Scheduled: Non-Follicular Patients
n=29 Participants
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
|
|---|---|---|---|---|
|
Time to Rituximab Failure (TTRF)
|
3.92 years
Interval 3.09 to 4.93
|
4.32 years
Interval 3.53 to 4.98
|
1.39 years
Interval 1.07 to
Upper boundary has not been reached
|
4.83 years
Interval 2.46 to
Upper boundary has not been reached
|
SECONDARY outcome
Timeframe: Assessed every 13 weeks until rituximab failure observed or August 2013, whichever occurred first.Population: Patients who were correctly randomized to one of the two maintenance arms.
TTFC is defined as the time from randomization to the time of first cytotoxic therapy (chemo and radio therapy), and censored as last follow-up time if no cytotoxic therapy has been used. Since median TTFC was not reached in 3 out of the 4 groups, 3-year TTFC was reported which was defined as the probability of not starting first cytotoxic therapy at 3 years.
Outcome measures
| Measure |
Rituximab Retreatment: Follicular Patients
n=143 Participants
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Scheduled: Follicular Patients
n=146 Participants
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Retreatment: Non-Follicular Patients
n=23 Participants
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Scheduled: Non-Follicular Patients
n=29 Participants
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
|
|---|---|---|---|---|
|
Time to First Cytotoxic Therapy (TTFC)
|
0.84 probability
Interval 0.78 to 0.9
|
0.95 probability
Interval 0.91 to 0.99
|
0.72 probability
Interval 0.55 to 0.94
|
1 probability
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Assessed at baseline and 6 months after randomization.Population: Patients with patient-reported outcomes (PRO) data available.
The overall HRQL was measured by the change in Functional Assessment of Cancer Therapy - General (FACT-G) from baseline to 6 months after randomization. The FACT-G is a 27-item assessment used to measure HRQL, specifically, physical, functional, social and emotional well-being. The total score ranges from 0 to 108, with higher scores indicating better HRQL.
Outcome measures
| Measure |
Rituximab Retreatment: Follicular Patients
n=128 Participants
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Scheduled: Follicular Patients
n=125 Participants
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Retreatment: Non-Follicular Patients
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
|
Rituximab Scheduled: Non-Follicular Patients
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
|
|---|---|---|---|---|
|
Overall Health-related Quality of Life (HRQL) at 6 Month After Randomization
|
1.04 units on a scale
Standard Deviation 12.82
|
-0.71 units on a scale
Standard Deviation 9.38
|
—
|
—
|
Adverse Events
Arm I: Induction Rituximab
Serious events: 23 serious events
Other events: 36 other events
Deaths: 0 deaths
Arm A: Rituximab Retreatment
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm B: Rituximab Scheduled
Serious events: 10 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I: Induction Rituximab
n=500 participants at risk
Patients received rituximab IV once a week for 4 weeks. Patients were re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab were randomized to one of the two treatment arms.
|
Arm A: Rituximab Retreatment
n=169 participants at risk
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
|
Arm B: Rituximab Scheduled
n=177 participants at risk
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
|
|---|---|---|---|
|
Immune system disorders
Anaphylaxis
|
0.40%
2/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.56%
1/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.56%
1/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Investigations
Neutrophil count decreased
|
0.40%
2/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
1.2%
2/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.59%
1/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.20%
1/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.59%
1/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.56%
1/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
General disorders
Fatigue
|
0.40%
2/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.59%
1/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
1.7%
3/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
General disorders
Fever
|
0.00%
0/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.56%
1/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.56%
1/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.20%
1/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.40%
2/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.20%
1/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Infections and infestations
Peripheral nerve infection
|
0.20%
1/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Infections and infestations
Infections and infestations - Other, spe
|
0.00%
0/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.56%
1/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.20%
1/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.56%
1/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.56%
1/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Psychiatric disorders
Anxiety
|
0.20%
1/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Nervous system disorders
Syncope
|
0.20%
1/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.59%
1/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.20%
1/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
General disorders
Non-cardiac chest pain
|
0.20%
1/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.56%
1/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Nervous system disorders
Neuralgia
|
0.20%
1/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.20%
1/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal di
|
0.20%
1/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
|
Immune system disorders
Cytokine release syndrome
|
1.6%
8/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
0.00%
0/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
Other adverse events
| Measure |
Arm I: Induction Rituximab
n=500 participants at risk
Patients received rituximab IV once a week for 4 weeks. Patients were re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab were randomized to one of the two treatment arms.
|
Arm A: Rituximab Retreatment
n=169 participants at risk
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
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Arm B: Rituximab Scheduled
n=177 participants at risk
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
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|---|---|---|---|
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General disorders
Fatigue
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7.2%
36/500 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
3.0%
5/169 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
|
7.9%
14/177 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
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Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place