Trial Outcomes & Findings for Safety and Efficacy Study of Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma (NCT NCT00994643)
NCT ID: NCT00994643
Last Updated: 2025-04-30
Results Overview
Patients were enrolled based on having obtained complete remission or at least a partial remission. Efficacy was therefore determined by the number of patients that remained in remission following treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
1 year
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
Treatment (Interleukin Therapy, Monoclonal Antibody)
Patients receive interleukin-2 SC twice weekly and rituximab IV once weekly in weeks 5-8 and 25-28. Courses repeat every 4 weeks for up to 7 months in the absence of disease progression or unacceptable toxicity.
Rituximab: Given IV
Interleukin-2: Given SC
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Interleukin Therapy, Monoclonal Antibody)
Patients receive interleukin-2 SC twice weekly and rituximab IV once weekly in weeks 5-8 and 25-28. Courses repeat every 4 weeks for up to 7 months in the absence of disease progression or unacceptable toxicity.
Rituximab: Given IV
Interleukin-2: Given SC
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Interleukin Therapy, Monoclonal Antibody)
n=11 Participants
Patients receive interleukin-2 SC twice weekly and rituximab IV once weekly in weeks 5-8 and 25-28. Courses repeat every 4 weeks for up to 7 months in the absence of disease progression or unacceptable toxicity.
Rituximab: Given IV
Interleukin-2: Given SC
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
59.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPatients were enrolled based on having obtained complete remission or at least a partial remission. Efficacy was therefore determined by the number of patients that remained in remission following treatment.
Outcome measures
| Measure |
Treatment (Interleukin Therapy, Monoclonal Antibody)
n=11 Participants
Patients receive interleukin-2 SC twice weekly and rituximab IV once weekly in weeks 5-8 and 25-28. Courses repeat every 4 weeks for up to 7 months in the absence of disease progression or unacceptable toxicity.
Rituximab: Given IV
Interleukin-2: Given SC
|
|---|---|
|
Assess the Efficacy of Combination Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma
|
6 Participants
|
Adverse Events
Treatment (Interleukin Therapy, Monoclonal Antibody)
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Interleukin Therapy, Monoclonal Antibody)
n=11 participants at risk
Patients receive interleukin-2 SC twice weekly and rituximab IV once weekly in weeks 5-8 and 25-28. Courses repeat every 4 weeks for up to 7 months in the absence of disease progression or unacceptable toxicity.
Rituximab: Given IV
Interleukin-2: Given SC
|
|---|---|
|
Nervous system disorders
Stroke (CNS cerebrovascular ischemia)
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
Infections and infestations
Febrile neutropenia
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Infections and infestations
Infection -Simusitis
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Blood and lymphatic system disorders
Absolute Neutrophil Count decreased
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
Other adverse events
| Measure |
Treatment (Interleukin Therapy, Monoclonal Antibody)
n=11 participants at risk
Patients receive interleukin-2 SC twice weekly and rituximab IV once weekly in weeks 5-8 and 25-28. Courses repeat every 4 weeks for up to 7 months in the absence of disease progression or unacceptable toxicity.
Rituximab: Given IV
Interleukin-2: Given SC
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Abdominal pain
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
General disorders
Achiness
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
Renal and urinary disorders
ALT
|
9.1%
1/11 • Number of events 4 • Two years and three months
|
|
Blood and lymphatic system disorders
ALC Decreased
|
9.1%
1/11 • Number of events 2 • Two years and three months
|
|
Blood and lymphatic system disorders
ANC decreased
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Metabolism and nutrition disorders
Anorexia
|
27.3%
3/11 • Number of events 3 • Two years and three months
|
|
Nervous system disorders
Anxiety
|
27.3%
3/11 • Number of events 4 • Two years and three months
|
|
Blood and lymphatic system disorders
AST
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Renal and urinary disorders
Awakening to urinate
|
36.4%
4/11 • Number of events 5 • Two years and three months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
27.3%
3/11 • Number of events 5 • Two years and three months
|
|
Blood and lymphatic system disorders
Bleeding
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Reproductive system and breast disorders
Blood in semen
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
General disorders
Bone pain
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Reproductive system and breast disorders
Breast pain
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Blood and lymphatic system disorders
Bruising
|
9.1%
1/11 • Number of events 3 • Two years and three months
|
|
Skin and subcutaneous tissue disorders
Bumps at location of IL-2 Injection
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Eye disorders
Change in vision
|
27.3%
3/11 • Number of events 4 • Two years and three months
|
|
General disorders
Chest pain
|
27.3%
3/11 • Number of events 4 • Two years and three months
|
|
General disorders
Chest tightness
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
General disorders
Chills
|
81.8%
9/11 • Number of events 14 • Two years and three months
|
|
Immune system disorders
Cold Virus
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
General disorders
Confusion
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Gastrointestinal disorders
Constipation
|
36.4%
4/11 • Number of events 5 • Two years and three months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
54.5%
6/11 • Number of events 6 • Two years and three months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.1%
1/11 • Number of events 2 • Two years and three months
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Skin and subcutaneous tissue disorders
Dermatology
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Gastrointestinal disorders
Diarrhea
|
45.5%
5/11 • Number of events 6 • Two years and three months
|
|
General disorders
Dizziness
|
27.3%
3/11 • Number of events 4 • Two years and three months
|
|
Eye disorders
Dry eyes
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
General disorders
Dry mouth
|
9.1%
1/11 • Number of events 2 • Two years and three months
|
|
General disorders
Dysgeusia
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
General disorders
Edema
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
General disorders
Fatigue
|
90.9%
10/11 • Number of events 14 • Two years and three months
|
|
General disorders
Fever
|
36.4%
4/11 • Number of events 6 • Two years and three months
|
|
Skin and subcutaneous tissue disorders
Flushing
|
9.1%
1/11 • Number of events 2 • Two years and three months
|
|
Immune system disorders
Flu like symptoms
|
36.4%
4/11 • Number of events 4 • Two years and three months
|
|
General disorders
Foot pain
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Reproductive system and breast disorders
Gynecomastia
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
General disorders
Headache
|
45.5%
5/11 • Number of events 7 • Two years and three months
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
9.1%
1/11 • Number of events 2 • Two years and three months
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
9.1%
1/11 • Number of events 2 • Two years and three months
|
|
Blood and lymphatic system disorders
Hypergylcemia
|
18.2%
2/11 • Number of events 3 • Two years and three months
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Blood and lymphatic system disorders
Hypertension
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Blood and lymphatic system disorders
Hypotension
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Infections and infestations
Infection
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
General disorders
Injection site redness
|
9.1%
1/11 • Number of events 2 • Two years and three months
|
|
General disorders
Injection site reaction
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
General disorders
Insomnia
|
36.4%
4/11 • Number of events 5 • Two years and three months
|
|
General disorders
Itching
|
27.3%
3/11 • Number of events 4 • Two years and three months
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
18.2%
2/11 • Number of events 3 • Two years and three months
|
|
General disorders
Local injection site sore
|
27.3%
3/11 • Number of events 3 • Two years and three months
|
|
Skin and subcutaneous tissue disorders
Lump on left side of scalp
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Nervous system disorders
Mood Swings
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
General disorders
Mucositis
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
54.5%
6/11 • Number of events 6 • Two years and three months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
General disorders
Nausea
|
45.5%
5/11 • Number of events 5 • Two years and three months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
18.2%
2/11 • Number of events 3 • Two years and three months
|
|
Nervous system disorders
Neuropathy
|
36.4%
4/11 • Number of events 4 • Two years and three months
|
|
General disorders
Night sweats
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Musculoskeletal and connective tissue disorders
Numbness
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
General disorders
Pain
|
27.3%
3/11 • Number of events 5 • Two years and three months
|
|
General disorders
Pain ankle
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Cardiac disorders
Palpitations
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
Nervous system disorders
Peripheral Neuropathy
|
18.2%
2/11 • Number of events 3 • Two years and three months
|
|
Skin and subcutaneous tissue disorders
Rash
|
45.5%
5/11 • Number of events 5 • Two years and three months
|
|
Nervous system disorders
Restless leg Syndrome
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Musculoskeletal and connective tissue disorders
Rib pain
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Reproductive system and breast disorders
Sexual problems
|
9.1%
1/11 • Number of events 2 • Two years and three months
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
9.1%
1/11 • Number of events 2 • Two years and three months
|
|
General disorders
Sinus congestion
|
27.3%
3/11 • Number of events 3 • Two years and three months
|
|
General disorders
Sinus pain
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
Skin and subcutaneous tissue disorders
Skin lump
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
General disorders
Speech Change
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
General disorders
Stomach pain
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
General disorders
Sweating
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
General disorders
Taste alteration
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Eye disorders
Tearing of eyes
|
18.2%
2/11 • Number of events 3 • Two years and three months
|
|
Nervous system disorders
Tremors
|
9.1%
1/11 • Number of events 2 • Two years and three months
|
|
General disorders
Trouble sleeping
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
Renal and urinary disorders
Urinary retention
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
Reproductive system and breast disorders
Urinary tract infection
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
General disorders
Voice changes
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
General disorders
Vomiting
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
Blood and lymphatic system disorders
WBC decreased
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
General disorders
Weakness
|
18.2%
2/11 • Number of events 2 • Two years and three months
|
|
General disorders
Weight gain
|
9.1%
1/11 • Number of events 1 • Two years and three months
|
|
General disorders
Weight loss
|
27.3%
3/11 • Number of events 4 • Two years and three months
|
|
General disorders
Nocturnal Wheezing
|
27.3%
3/11 • Number of events 3 • Two years and three months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place