Trial Outcomes & Findings for Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non-Hodgkin's Lymphoma (NCT NCT01316523)
NCT ID: NCT01316523
Last Updated: 2025-11-21
Results Overview
Responses will be assessed by the Revised Working Group Response Criteria for Malignant Lymphoma. A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease. Response Rate defined as the proportion of patients whose best response was complete response (CR; confirmed or unconfirmed) or partial response (PR).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
4 months
Results posted on
2025-11-21
Participant Flow
Participant milestones
| Measure |
Lenalidomide + Rituximab
Patients will receive lenalidomide 20 mg daily (oral), on days 1-21 of a 28 day cycle. Rituximab 375 mg/m2 (into the vein) will be administered weekly for 4 doses starting day 15 of cycle 1, to be repeated if patient does not achieve a complete response after cycle 4, on days 1, 8, 15 and 22 of cycle 5.
Rituximab: Rituximab 375 mg/m2/wk x 4 weeks, to begin Day 15 of cycle 1. After 4 cycles of therapy if patient does not respond to treatment, the patient will receive a second course of Rituximab.
Lenalidomide: Lenalidomide will be taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, there are too many side effects, or after twelve cycles if the patient responds to treatment.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Lenalidomide + Rituximab
n=30 Participants
Patients will receive lenalidomide 20 mg daily (oral), on days 1-21 of a 28 day cycle. Rituximab 375 mg/m2 (into the vein) will be administered weekly for 4 doses starting day 15 of cycle 1, to be repeated if patient does not achieve a complete response after cycle 4, on days 1, 8, 15 and 22 of cycle 5.
Rituximab: Rituximab 375 mg/m2/wk x 4 weeks, to begin Day 15 of cycle 1. After 4 cycles of therapy if patient does not respond to treatment, the patient will receive a second course of Rituximab.
Lenalidomide: Lenalidomide will be taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, there are too many side effects, or after twelve cycles if the patient responds to treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=68 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=68 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=68 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=68 Participants
|
PRIMARY outcome
Timeframe: 4 monthsResponses will be assessed by the Revised Working Group Response Criteria for Malignant Lymphoma. A complete response is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. A partial response is regression of measurable disease and no new sites of disease. Stable disease is failure to attain a complete response/partial response or progressive disease. Response Rate defined as the proportion of patients whose best response was complete response (CR; confirmed or unconfirmed) or partial response (PR).
Outcome measures
| Measure |
Lenalidomide + Rituximab
n=27 Participants
Patients will receive lenalidomide 20 mg daily (oral), on days 1-21 of a 28 day cycle. Rituximab 375 mg/m2 (into the vein) will be administered weekly for 4 doses starting day 15 of cycle 1, to be repeated if patient does not achieve a complete response after cycle 4, on days 1, 8, 15 and 22 of cycle 5.
Rituximab: Rituximab 375 mg/m2/wk x 4 weeks, to begin Day 15 of cycle 1. After 4 cycles of therapy if patient does not respond to treatment, the patient will receive a second course of Rituximab.
Lenalidomide: Lenalidomide will be taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, there are too many side effects, or after twelve cycles if the patient responds to treatment.
|
|---|---|
|
Response Rate to Treatment
|
0.82 proportion of patients with CR or PR
|
SECONDARY outcome
Timeframe: Up to about 13 years.Time from when the patient started treatment to the time the patient receives next treatment.
Outcome measures
| Measure |
Lenalidomide + Rituximab
n=27 Participants
Patients will receive lenalidomide 20 mg daily (oral), on days 1-21 of a 28 day cycle. Rituximab 375 mg/m2 (into the vein) will be administered weekly for 4 doses starting day 15 of cycle 1, to be repeated if patient does not achieve a complete response after cycle 4, on days 1, 8, 15 and 22 of cycle 5.
Rituximab: Rituximab 375 mg/m2/wk x 4 weeks, to begin Day 15 of cycle 1. After 4 cycles of therapy if patient does not respond to treatment, the patient will receive a second course of Rituximab.
Lenalidomide: Lenalidomide will be taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, there are too many side effects, or after twelve cycles if the patient responds to treatment.
|
|---|---|
|
Time to Next Treatment.
|
97.8 months
Interval 63.0 to
Upper bound not reached due to study being terminated.
|
SECONDARY outcome
Timeframe: Up to about 13 yearsMedian overall survival measured as the time from start of treatment to the date of death or the last date the patient was known to be alive.
Outcome measures
| Measure |
Lenalidomide + Rituximab
n=27 Participants
Patients will receive lenalidomide 20 mg daily (oral), on days 1-21 of a 28 day cycle. Rituximab 375 mg/m2 (into the vein) will be administered weekly for 4 doses starting day 15 of cycle 1, to be repeated if patient does not achieve a complete response after cycle 4, on days 1, 8, 15 and 22 of cycle 5.
Rituximab: Rituximab 375 mg/m2/wk x 4 weeks, to begin Day 15 of cycle 1. After 4 cycles of therapy if patient does not respond to treatment, the patient will receive a second course of Rituximab.
Lenalidomide: Lenalidomide will be taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, there are too many side effects, or after twelve cycles if the patient responds to treatment.
|
|---|---|
|
Overall Survival
|
NA months
Median OS and 95% Confidence Interval could not be determined because of an insufficient number of participants with events due to the study being prematurely terminated.
|
SECONDARY outcome
Timeframe: Up to about 12 years.Defined as the number of patients experiencing treatment-related adverse events as graded according to the National Cancer Institute Common Toxicity Criteria Version (NCI CTCAE) 4.0.
Outcome measures
| Measure |
Lenalidomide + Rituximab
n=30 Participants
Patients will receive lenalidomide 20 mg daily (oral), on days 1-21 of a 28 day cycle. Rituximab 375 mg/m2 (into the vein) will be administered weekly for 4 doses starting day 15 of cycle 1, to be repeated if patient does not achieve a complete response after cycle 4, on days 1, 8, 15 and 22 of cycle 5.
Rituximab: Rituximab 375 mg/m2/wk x 4 weeks, to begin Day 15 of cycle 1. After 4 cycles of therapy if patient does not respond to treatment, the patient will receive a second course of Rituximab.
Lenalidomide: Lenalidomide will be taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, there are too many side effects, or after twelve cycles if the patient responds to treatment.
|
|---|---|
|
Number of Patients Experiencing Treatment-related Adverse Events.
|
28 participants
|
SECONDARY outcome
Timeframe: Up to 14 months.The duration of response is measured from the time measurement criteria are met for complete response/partial response(whichever status is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of response is measured from the time measurement criteria are first met for complete response until the first date that recurrent disease is objectively documented.
Outcome measures
| Measure |
Lenalidomide + Rituximab
n=27 Participants
Patients will receive lenalidomide 20 mg daily (oral), on days 1-21 of a 28 day cycle. Rituximab 375 mg/m2 (into the vein) will be administered weekly for 4 doses starting day 15 of cycle 1, to be repeated if patient does not achieve a complete response after cycle 4, on days 1, 8, 15 and 22 of cycle 5.
Rituximab: Rituximab 375 mg/m2/wk x 4 weeks, to begin Day 15 of cycle 1. After 4 cycles of therapy if patient does not respond to treatment, the patient will receive a second course of Rituximab.
Lenalidomide: Lenalidomide will be taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, there are too many side effects, or after twelve cycles if the patient responds to treatment.
|
|---|---|
|
Duration of Response From Start of Therapy
|
2 months
Interval 2.0 to 14.0
|
Adverse Events
Lenalidomide + Rituximab
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lenalidomide + Rituximab
n=30 participants at risk
Patients will receive lenalidomide 20 mg daily (oral), on days 1-21 of a 28 day cycle. Rituximab 375 mg/m2 (into the vein) will be administered weekly for 4 doses starting day 15 of cycle 1, to be repeated if patient does not achieve a complete response after cycle 4, on days 1, 8, 15 and 22 of cycle 5.
Rituximab: Rituximab 375 mg/m2/wk x 4 weeks, to begin Day 15 of cycle 1. After 4 cycles of therapy if patient does not respond to treatment, the patient will receive a second course of Rituximab.
Lenalidomide: Lenalidomide will be taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, there are too many side effects, or after twelve cycles if the patient responds to treatment.
|
|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
3.3%
1/30 • About 12 years 9 months
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • About 12 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • About 12 years 9 months
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
3.3%
1/30 • About 12 years 9 months
|
|
Cardiac disorders
Cardiac disorders - Palpitations
|
3.3%
1/30 • About 12 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.3%
1/30 • About 12 years 9 months
|
|
Nervous system disorders
Hydrocephalus
|
3.3%
1/30 • About 12 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.3%
1/30 • About 12 years 9 months
|
|
Nervous system disorders
Syncope
|
3.3%
1/30 • About 12 years 9 months
|
Other adverse events
| Measure |
Lenalidomide + Rituximab
n=30 participants at risk
Patients will receive lenalidomide 20 mg daily (oral), on days 1-21 of a 28 day cycle. Rituximab 375 mg/m2 (into the vein) will be administered weekly for 4 doses starting day 15 of cycle 1, to be repeated if patient does not achieve a complete response after cycle 4, on days 1, 8, 15 and 22 of cycle 5.
Rituximab: Rituximab 375 mg/m2/wk x 4 weeks, to begin Day 15 of cycle 1. After 4 cycles of therapy if patient does not respond to treatment, the patient will receive a second course of Rituximab.
Lenalidomide: Lenalidomide will be taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, there are too many side effects, or after twelve cycles if the patient responds to treatment.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
40.0%
12/30 • About 12 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
2/30 • About 12 years 9 months
|
|
Gastrointestinal disorders
Nausea
|
30.0%
9/30 • About 12 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
2/30 • About 12 years 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
10.0%
3/30 • About 12 years 9 months
|
|
Nervous system disorders
Nervous system disorders - Other
|
20.0%
6/30 • About 12 years 9 months
|
|
Investigations
Neutrophil count decreased
|
13.3%
4/30 • About 12 years 9 months
|
|
General disorders
Non-cardiac chest pain
|
6.7%
2/30 • About 12 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
10.0%
3/30 • About 12 years 9 months
|
|
General disorders
Pain
|
16.7%
5/30 • About 12 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
26.7%
8/30 • About 12 years 9 months
|
|
Nervous system disorders
Paresthesia
|
6.7%
2/30 • About 12 years 9 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
5/30 • About 12 years 9 months
|
|
Investigations
Platelet count decreased
|
10.0%
3/30 • About 12 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
3/30 • About 12 years 9 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
5/30 • About 12 years 9 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
2/30 • About 12 years 9 months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
6.7%
2/30 • About 12 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
10.0%
3/30 • About 12 years 9 months
|
|
Infections and infestations
Sinusitis
|
6.7%
2/30 • About 12 years 9 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
33.3%
10/30 • About 12 years 9 months
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
10.0%
3/30 • About 12 years 9 months
|
|
Nervous system disorders
Syncope
|
10.0%
3/30 • About 12 years 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
10.0%
3/30 • About 12 years 9 months
|
|
Infections and infestations
Upper respiratory infection
|
33.3%
10/30 • About 12 years 9 months
|
|
Renal and urinary disorders
Urinary frequency
|
10.0%
3/30 • About 12 years 9 months
|
|
Renal and urinary disorders
Urinary incontinence
|
6.7%
2/30 • About 12 years 9 months
|
|
Renal and urinary disorders
Urinary tract infection
|
6.7%
2/30 • About 12 years 9 months
|
|
Reproductive system and breast disorders
Vaginal dryness
|
6.7%
2/30 • About 12 years 9 months
|
|
Ear and labyrinth disorders
Vertigo
|
10.0%
3/30 • About 12 years 9 months
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
4/30 • About 12 years 9 months
|
|
Investigations
White blood cell decreased
|
16.7%
5/30 • About 12 years 9 months
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
4/30 • About 12 years 9 months
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
3/30 • About 12 years 9 months
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
10/30 • About 12 years 9 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.7%
2/30 • About 12 years 9 months
|
|
Vascular disorders
Hot flashes
|
6.7%
2/30 • About 12 years 9 months
|
|
Vascular disorders
Hypotension
|
6.7%
2/30 • About 12 years 9 months
|
|
Infections and infestations
Infections and infestations - Other
|
16.7%
5/30 • About 12 years 9 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
6.7%
2/30 • About 12 years 9 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
6.7%
2/30 • About 12 years 9 months
|
|
Psychiatric disorders
Insomnia
|
20.0%
6/30 • About 12 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
6.7%
2/30 • About 12 years 9 months
|
|
Infections and infestations
Lung infection
|
10.0%
3/30 • About 12 years 9 months
|
|
Investigations
Lymphocyte count decreased
|
23.3%
7/30 • About 12 years 9 months
|
|
General disorders
Malaise
|
6.7%
2/30 • About 12 years 9 months
|
|
Nervous system disorders
Memory impairment
|
6.7%
2/30 • About 12 years 9 months
|
|
General disorders
Fatigue
|
46.7%
14/30 • About 12 years 9 months
|
|
General disorders
Fever
|
20.0%
6/30 • About 12 years 9 months
|
|
General disorders
Flu like symptoms
|
6.7%
2/30 • About 12 years 9 months
|
|
Injury, poisoning and procedural complications
Fracture
|
6.7%
2/30 • About 12 years 9 months
|
|
General disorders
Gait disturbance
|
6.7%
2/30 • About 12 years 9 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
3/30 • About 12 years 9 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
20.0%
6/30 • About 12 years 9 months
|
|
General disorders
General disorders and administration site conditions - Other
|
6.7%
2/30 • About 12 years 9 months
|
|
General disorders
Generalized muscle weakness
|
10.0%
3/30 • About 12 years 9 months
|
|
Nervous system disorders
Headache
|
20.0%
6/30 • About 12 years 9 months
|
|
Vascular disorders
Hematoma
|
6.7%
2/30 • About 12 years 9 months
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
5/30 • About 12 years 9 months
|
|
Psychiatric disorders
Anxiety
|
10.0%
3/30 • About 12 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
2/30 • About 12 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
13.3%
4/30 • About 12 years 9 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
4/30 • About 12 years 9 months
|
|
Gastrointestinal disorders
Bloating
|
10.0%
3/30 • About 12 years 9 months
|
|
Injury, poisoning and procedural complications
Bruising
|
13.3%
4/30 • About 12 years 9 months
|
|
Cardiac disorders
Cardiac disorders - Other
|
10.0%
3/30 • About 12 years 9 months
|
|
Eye disorders
Cataract
|
6.7%
2/30 • About 12 years 9 months
|
|
General disorders
Chills
|
10.0%
3/30 • About 12 years 9 months
|
|
Gastrointestinal disorders
Constipation
|
23.3%
7/30 • About 12 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
9/30 • About 12 years 9 months
|
|
Psychiatric disorders
Depression
|
6.7%
2/30 • About 12 years 9 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
10/30 • About 12 years 9 months
|
|
Nervous system disorders
Dizziness
|
10.0%
3/30 • About 12 years 9 months
|
|
Eye disorders
Dry eye
|
10.0%
3/30 • About 12 years 9 months
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
3/30 • About 12 years 9 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
2/30 • About 12 years 9 months
|
|
Nervous system disorders
Dysgeusia
|
10.0%
3/30 • About 12 years 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
4/30 • About 12 years 9 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
6.7%
2/30 • About 12 years 9 months
|
|
General disorders
Edema face
|
6.7%
2/30 • About 12 years 9 months
|
|
General disorders
Edema limbs
|
26.7%
8/30 • About 12 years 9 months
|
|
Eye disorders
Eye disorders - Other
|
10.0%
3/30 • About 12 years 9 months
|
|
Injury, poisoning and procedural complications
Fall
|
13.3%
4/30 • About 12 years 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place