Trial Outcomes & Findings for Rituximab and Denileukin Diftitox in Treating Patients With Previously Untreated Stage III or Stage IV Follicular B-Cell Non-Hodgkin's Lymphoma (NCT NCT00460109)

Last Updated: 2017-04-18

Results Overview

A confirmed tumor response is defined to be either a CR, CRu or PR. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Response criteria for non-Hodgkin's lymphoma (NHL) will be followed. Complete response (CR): (a) Complete disappearance of all detectable disease and disease-related symptoms; (b) All lymph nodes and nodal masses must have regressed to normal size; (c) the spleen must have regressed; CR/unconfirmed (CRu): Those patients who fulfill the criteria in (a) and (c), but with a residual lymph node mass that has regressed by more that 75% in the sum of the products of the greatest diameters (SPD). Partial response (PR): ≥50% decrease in SPD of the six largest dominant nodes or nodal masses; no increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD; No new sites of disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2017-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Rituximab + Denileukin Diftitox Patients receive 375 mg/m\^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	24
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab + Denileukin Diftitox Patients receive 375 mg/m\^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Overall Study Death	1

Baseline Characteristics

Rituximab and Denileukin Diftitox in Treating Patients With Previously Untreated Stage III or Stage IV Follicular B-Cell Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab + Denileukin Diftitox n=23 Participants Patients receive 375 mg/m\^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Age, Continuous	60.0 years n=99 Participants
Sex: Female, Male Female	11 Participants n=99 Participants
Sex: Female, Male Male	12 Participants n=99 Participants
Region of Enrollment United States	23 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome measures
Measure	Rituximab + Denileukin Diftitox n=23 Participants Patients receive 375 mg/m\^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Proportion of Confirmed Tumor Response (Complete Response [CR], Unconfirmed CR, and Partial Response)	0.48 proportion of participants Interval 0.27 to 0.69

SECONDARY outcome

Timeframe: Up to 5 years

Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Rituximab + Denileukin Diftitox n=23 Participants Patients receive 375 mg/m\^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Survival Time	NA (MEDIAN) The median overall survival was not reached.

SECONDARY outcome

Timeframe: Up to 5 years

Time to disease progression is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time to disease progression will be estimated using the method of Kaplan-Meier. Progression is defined using the response criteria for non-Hodgkin's lymphoma, as at least a 50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PRs or non-responders, or appearance of any new lesion during or at the end of therapy.

Outcome measures

Outcome measures
Measure	Rituximab + Denileukin Diftitox n=23 Participants Patients receive 375 mg/m\^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Time to Disease Progression	NA (MEDIAN) Median time to progression was not reached.

SECONDARY outcome

Timeframe: Up to 5 years

Population: Overall Number of Participants Analyzed reflects only the number of participants with reported data for this outcome.

Duration of response (DOR) is defined as the time from the date at which the patient's objective status is first noted to be either a CR, CRu or PR to the earliest date of progression. The distribution of DOR will be estimated using Kaplan-Meier methods. Response criteria for non-Hodgkin's lymphoma (NHL) will be followed. Complete response (CR): (a) Complete disappearance of all detectable disease and disease-related symptoms; (b) All lymph nodes and nodal masses must have regressed to normal size; (c) the spleen must have regressed; CR/unconfirmed (CRu): Those patients who fulfill the criteria in (a) and (c), but with a residual lymph node mass that has regressed by more that 75% in the sum of the products of the greatest diameters (SPD). Partial response (PR): ≥50% decrease in SPD of the six largest dominant nodes or nodal masses; no increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD; No new sites of disease.

Outcome measures

Outcome measures
Measure	Rituximab + Denileukin Diftitox n=6 Participants Patients receive 375 mg/m\^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Duration of Response	22.5 months Interval 7.3 to 22.5

SECONDARY outcome

Timeframe: Up to 5 years

Time to subsequent therapy is defined to be the time from the end of active treatment date to the date subsequent therapy is initiated. The distribution of time to subsequent therapy will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Rituximab + Denileukin Diftitox n=23 Participants Patients receive 375 mg/m\^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Time to Subsequent Therapy	NA months Interval 8.5 to Median Time to Subsequent Therapy and the upper limit of the 95% confidence interval were not reached.

Adverse Events

Rituximab + Denileukin Diftitox

Serious events: 7 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rituximab + Denileukin Diftitox n=23 participants at risk Patients receive 375 mg/m\^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Cardiac disorders Cardiac valve disease	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Cardiac disorders Left ventricular dysfunction	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Cardiac disorders Myocardial ischemia	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Cardiac disorders Premature ventricular contractions	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Cardiac disorders Ventricular bigeminy	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Gastrointestinal disorders Abdominal pain	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Gastrointestinal disorders Constipation	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Gastrointestinal disorders Dyspepsia	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Gastrointestinal disorders Enteritis	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Gastrointestinal disorders Nausea	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Gastrointestinal disorders Small intestinal obstruction	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Gastrointestinal disorders Vomiting	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
General disorders Edema limbs	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
General disorders Fatigue	8.7% 2/23 • Number of events 2 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
General disorders Localized edema	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Immune system disorders Cytokine release syndrome	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Investigations Cardiac troponin I increased	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Investigations Creatine phosphokinase increased	8.7% 2/23 • Number of events 2 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Metabolism and nutrition disorders Blood glucose increased	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Metabolism and nutrition disorders Dehydration	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Metabolism and nutrition disorders Serum albumin decreased	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Metabolism and nutrition disorders Serum calcium decreased	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Metabolism and nutrition disorders Serum phosphate decreased	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Metabolism and nutrition disorders Serum sodium decreased	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Musculoskeletal and connective tissue disorders Muscle weakness	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Musculoskeletal and connective tissue disorders Myalgia	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Musculoskeletal and connective tissue disorders Myositis	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Nervous system disorders Syncope	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Skin and subcutaneous tissue disorders Rash desquamating	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Vascular disorders Capillary leak syndrome	21.7% 5/23 • Number of events 5 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Vascular disorders Hypotension	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Vascular disorders Thrombosis	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.

Other adverse events

Other adverse events
Measure	Rituximab + Denileukin Diftitox n=23 participants at risk Patients receive 375 mg/m\^2 rituximab IV on days 1, 8, 15, and 22. Patients also receive 18 mcg/kg/day denileukin diftitox IV over 15-60 minutes on days 1-5. Treatment with denileukin diftitox repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Hemoglobin decreased	47.8% 11/23 • Number of events 26 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Cardiac disorders Cardiac pain	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Cardiac disorders Ventricular tachycardia	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Eye disorders Retinopathy	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Gastrointestinal disorders Constipation	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Gastrointestinal disorders Diarrhea	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Gastrointestinal disorders Dry mouth	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Gastrointestinal disorders Mucositis oral	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Gastrointestinal disorders Nausea	8.7% 2/23 • Number of events 2 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Gastrointestinal disorders Vomiting	8.7% 2/23 • Number of events 2 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
General disorders Chest pain	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
General disorders Chills	13.0% 3/23 • Number of events 3 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
General disorders Edema limbs	8.7% 2/23 • Number of events 2 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
General disorders Fatigue	13.0% 3/23 • Number of events 3 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
General disorders Pain	8.7% 2/23 • Number of events 2 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Immune system disorders Cytokine release syndrome	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Immune system disorders Hypersensitivity	26.1% 6/23 • Number of events 7 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Infections and infestations Catheter related infection	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Infections and infestations Wound infection	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Investigations Activated partial thromboplastin time prolonged	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Investigations Alanine aminotransferase increased	26.1% 6/23 • Number of events 6 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Investigations Aspartate aminotransferase increased	26.1% 6/23 • Number of events 6 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Investigations Creatinine increased	13.0% 3/23 • Number of events 3 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Investigations Laboratory test abnormal	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Investigations Leukocyte count decreased	13.0% 3/23 • Number of events 4 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Investigations Lymphocyte count decreased	17.4% 4/23 • Number of events 4 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Investigations Neutrophil count decreased	13.0% 3/23 • Number of events 3 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Investigations Platelet count decreased	30.4% 7/23 • Number of events 8 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Metabolism and nutrition disorders Blood glucose increased	17.4% 4/23 • Number of events 5 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Metabolism and nutrition disorders Serum albumin decreased	39.1% 9/23 • Number of events 11 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Metabolism and nutrition disorders Serum calcium decreased	8.7% 2/23 • Number of events 2 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Metabolism and nutrition disorders Serum potassium decreased	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Metabolism and nutrition disorders Serum potassium increased	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Metabolism and nutrition disorders Serum sodium decreased	13.0% 3/23 • Number of events 3 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Musculoskeletal and connective tissue disorders Back pain	4.3% 1/23 • Number of events 2 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Musculoskeletal and connective tissue disorders Bone pain	4.3% 1/23 • Number of events 2 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Musculoskeletal and connective tissue disorders Muscle weakness	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Nervous system disorders Depressed level of consciousness	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Nervous system disorders Headache	8.7% 2/23 • Number of events 3 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Renal and urinary disorders Protein urine positive	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Skin and subcutaneous tissue disorders Pruritus	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Skin and subcutaneous tissue disorders Rash desquamating	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Vascular disorders Capillary leak syndrome	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Vascular disorders Flushing	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Vascular disorders Hypertension	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Vascular disorders Hypotension	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.
Vascular disorders Thrombosis	4.3% 1/23 • Number of events 1 • Adverse events are assessed during Treatment (weekly while receiving treatment and prior to the start of a new cycle) and during Observation (1 month after completing treatment, at 4, 7, and 10 months after completing treatment, 1 year after treatment, and every 6 months for years 2-5); up to 5 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported.

Additional Information

Stephen M. Ansell, M.D., Ph.D.

Mayo Clinic

Phone: 507/284-4642

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place