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Trial record 9 of 68 for:    abp 798

Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01145495
Recruitment Status : Active, not recruiting
First Posted : June 16, 2010
Results First Posted : February 20, 2014
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ann Arbor Stage II Grade 1 Contiguous Follicular Lymphoma
Ann Arbor Stage II Grade 1 Non-Contiguous Follicular Lymphoma
Ann Arbor Stage II Grade 2 Contiguous Follicular Lymphoma
Ann Arbor Stage II Grade 2 Non-Contiguous Follicular Lymphoma
Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma
Ann Arbor Stage II Grade 3 Non-Contiguous Follicular Lymphoma
Ann Arbor Stage III Grade 1 Follicular Lymphoma
Ann Arbor Stage III Grade 2 Follicular Lymphoma
Ann Arbor Stage III Grade 3 Follicular Lymphoma
Ann Arbor Stage IV Grade 1 Follicular Lymphoma
Ann Arbor Stage IV Grade 2 Follicular Lymphoma
Ann Arbor Stage IV Grade 3 Follicular Lymphoma
Interventions Other: Laboratory Biomarker Analysis
Drug: Lenalidomide
Biological: Rituximab
Enrollment 63
Recruitment Details Between June 2010 and November 2011, 66 participants were recruited.
Pre-assignment Details Three participants did not receive protocol treatment and were dropped from all analyses.
Arm/Group Title Treatment (Lenalidomide, Rituximab)
Hide Arm/Group Description

Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.

>

> rituximab: Given IV

>

> lenalidomide: Given orally

Period Title: Overall Study
Started 63
Completed 51
Not Completed 12
Reason Not Completed
Adverse Event             6
Withdrawal by Subject             5
Disease progression after respone             1
Arm/Group Title Treatment (Lenalidomide, Rituximab)
Hide Arm/Group Description

Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

lenalidomide: Given orally

Overall Number of Baseline Participants 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 63 participants
53
(32 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Female
32
  50.8%
Male
31
  49.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 63 participants
63
Follicular Lymphoma International Prognostic Index (FLIPI)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 63 participants
0-1 19
2 42
Not reported 2
[1]
Measure Description:

Follicular Lymphoma International Prognostic Index (FLIPI) (abstracted from Solal-Céligny et al., Blood, 2004. 104(5): p. 1258-1265)

Factors (1 point for each variable present):

  • Age > 60y
  • Ann Arbor Stage III-IV (range I-IV, with III and IV indicating highest risk)
  • Hemoglobin level < 12 g/dL
  • Lactate dehydrogenase (LDH) level > upper limit of normal (ULN)
  • >= 4 nodal sites of disease

Risk category (factors):

  • Low risk (0 or 1)
  • Intermediate risk (2)
  • High risk (> 3)
1.Primary Outcome
Title Number of Participants Who Achieved a Complete Response
Hide Description Response is assessed by investigator according to International Working Group (IWG) criteria. Complete response requires disappearance of all evidence of disease.
Time Frame At 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
At the time of analysis, 54 participants had adequate to evaluate response.
Arm/Group Title Treatment (Lenalidomide, Rituximab)
Hide Arm/Group Description:

Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

lenalidomide: Given orally

Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: participants
39
2.Secondary Outcome
Title Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hide Description Data will be summarized using frequency tables.
Time Frame Up to 10 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Time to Disease Progression
Hide Description Kaplan-Meier method will be used.
Time Frame Up to 10 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Time to Best Response
Hide Description Kaplan-Meier method will be used.
Time Frame Up to 10 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Lenalidomide, Rituximab)
Hide Arm/Group Description lenalidomide: Given orally
All-Cause Mortality
Treatment (Lenalidomide, Rituximab)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Lenalidomide, Rituximab)
Affected / at Risk (%) # Events
Total   15/63 (23.81%)    
Blood and lymphatic system disorders   
Anemia  1  5/63 (7.94%)  7
Leukocytosis  1  1/63 (1.59%)  1
Cardiac disorders   
Chest pain - cardiac  1  1/63 (1.59%)  1
Sinus bradycardia  1  2/63 (3.17%)  2
Eye disorders   
Photophobia  1  1/63 (1.59%)  1
Watering eyes  1  1/63 (1.59%)  1
Gastrointestinal disorders   
Abdominal distension  1  1/63 (1.59%)  1
Abdominal pain  1  1/63 (1.59%)  1
Bloating  1  1/63 (1.59%)  1
Constipation  1  6/63 (9.52%)  12
Dyspepsia  1  2/63 (3.17%)  2
Enterocolitis  1  1/63 (1.59%)  1
Gastrointestinal disorders - Other  1  2/63 (3.17%)  2
Ileal perforation  1  1/63 (1.59%)  1
Mucositis oral  1  2/63 (3.17%)  2
Nausea  1  3/63 (4.76%)  6
Vomiting  1  2/63 (3.17%)  3
General disorders   
Chills  1  1/63 (1.59%)  1
Edema limbs  1  1/63 (1.59%)  1
Fatigue  1  8/63 (12.70%)  13
Fever  1  3/63 (4.76%)  3
Infusion related reaction  1  2/63 (3.17%)  2
Non-cardiac chest pain  1  1/63 (1.59%)  1
Pain  1  2/63 (3.17%)  2
Immune system disorders   
Allergic reaction  1  1/63 (1.59%)  1
Serum sickness  1  1/63 (1.59%)  1
Infections and infestations   
Skin infection  1  2/63 (3.17%)  2
Urinary tract infection  1  1/63 (1.59%)  1
Injury, poisoning and procedural complications   
Bruising  1  1/63 (1.59%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  1/63 (1.59%)  1
Alanine aminotransferase increased  1  4/63 (6.35%)  4
Alkaline phosphatase increased  1  1/63 (1.59%)  1
Aspartate aminotransferase increased  1  2/63 (3.17%)  2
Blood bilirubin increased  1  2/63 (3.17%)  2
Hemoglobin increased  1  1/63 (1.59%)  1
INR increased  1  1/63 (1.59%)  1
Lymphocyte count decreased  1  10/63 (15.87%)  13
Neutrophil count decreased  1  7/63 (11.11%)  8
Platelet count decreased  1  6/63 (9.52%)  6
White blood cell decreased  1  4/63 (6.35%)  4
Metabolism and nutrition disorders   
Anorexia  1  1/63 (1.59%)  1
Dehydration  1  1/63 (1.59%)  1
Hyperglycemia  1  3/63 (4.76%)  3
Hypoalbuminemia  1  3/63 (4.76%)  3
Hypocalcemia  1  2/63 (3.17%)  2
Hypokalemia  1  2/63 (3.17%)  2
Hyponatremia  1  2/63 (3.17%)  2
Hypophosphatemia  1  1/63 (1.59%)  1
Tumor lysis syndrome  1  2/63 (3.17%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/63 (3.17%)  3
Back pain  1  2/63 (3.17%)  2
Generalized muscle weakness  1  1/63 (1.59%)  1
Myalgia  1  3/63 (4.76%)  4
Neck pain  1  1/63 (1.59%)  1
Pain in extremity  1  1/63 (1.59%)  1
Nervous system disorders   
Dizziness  1  1/63 (1.59%)  1
Dysgeusia  1  1/63 (1.59%)  1
Headache  1  2/63 (3.17%)  2
Memory impairment  1  1/63 (1.59%)  1
Peripheral sensory neuropathy  1  3/63 (4.76%)  3
Psychiatric disorders   
Anxiety  1  2/63 (3.17%)  4
Insomnia  1  1/63 (1.59%)  1
Renal and urinary disorders   
Hematuria  1  1/63 (1.59%)  1
Proteinuria  1  1/63 (1.59%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/63 (3.17%)  3
Dyspnea  1  1/63 (1.59%)  1
Skin and subcutaneous tissue disorders   
Dry skin  1  1/63 (1.59%)  1
Erythema multiforme  1  1/63 (1.59%)  1
Pruritus  1  2/63 (3.17%)  2
Rash maculo-papular  1  4/63 (6.35%)  4
Vascular disorders   
Hot flashes  1  1/63 (1.59%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Lenalidomide, Rituximab)
Affected / at Risk (%) # Events
Total   60/63 (95.24%)    
Blood and lymphatic system disorders   
Anemia  1  23/63 (36.51%)  79
Blood and lymphatic system disorders - Other  1  3/63 (4.76%)  3
Febrile neutropenia  1  1/63 (1.59%)  3
Cardiac disorders   
Atrial fibrillation  1  1/63 (1.59%)  2
Chest pain - cardiac  1  2/63 (3.17%)  5
Palpitations  1  1/63 (1.59%)  2
Sinus bradycardia  1  3/63 (4.76%)  10
Sinus tachycardia  1  1/63 (1.59%)  4
Ear and labyrinth disorders   
Ear pain  1  1/63 (1.59%)  3
Vertigo  1  1/63 (1.59%)  1
Endocrine disorders   
Hyperthyroidism  1  1/63 (1.59%)  1
Hypothyroidism  1  4/63 (6.35%)  6
Eye disorders   
Blurred vision  1  2/63 (3.17%)  2
Conjunctivitis  1  1/63 (1.59%)  1
Gastrointestinal disorders   
Abdominal pain  1  7/63 (11.11%)  21
Bloating  1  3/63 (4.76%)  3
Constipation  1  18/63 (28.57%)  46
Diarrhea  1  20/63 (31.75%)  41
Dry mouth  1  2/63 (3.17%)  2
Dyspepsia  1  9/63 (14.29%)  24
Dysphagia  1  1/63 (1.59%)  1
Gastroesophageal reflux disease  1  6/63 (9.52%)  8
Gastrointestinal disorders - Other  1  1/63 (1.59%)  4
Ileal perforation  1  1/63 (1.59%)  1
Lip pain  1  1/63 (1.59%)  1
Mucositis oral  1  6/63 (9.52%)  10
Nausea  1  16/63 (25.40%)  39
Oral hemorrhage  1  1/63 (1.59%)  1
Stomach pain  1  3/63 (4.76%)  3
Vomiting  1  4/63 (6.35%)  5
General disorders   
Chills  1  5/63 (7.94%)  14
Edema limbs  1  11/63 (17.46%)  40
Facial pain  1  1/63 (1.59%)  1
Fatigue  1  52/63 (82.54%)  258
Fever  1  5/63 (7.94%)  6
Flu like symptoms  1  1/63 (1.59%)  1
General disorders and administration site conditions - Other  1  1/63 (1.59%)  1
Infusion related reaction  1  20/63 (31.75%)  25
Localized edema  1  1/63 (1.59%)  4
Non-cardiac chest pain  1  4/63 (6.35%)  8
Pain  1  9/63 (14.29%)  19
Immune system disorders   
Allergic reaction  1  5/63 (7.94%)  11
Cytokine release syndrome  1  2/63 (3.17%)  2
Infections and infestations   
Appendicitis  1  1/63 (1.59%)  1
Gum infection  1  1/63 (1.59%)  1
Infections and infestations - Other  1  2/63 (3.17%)  2
Lung infection  1  1/63 (1.59%)  1
Rash pustular  1  1/63 (1.59%)  2
Sinusitis  1  4/63 (6.35%)  6
Skin infection  1  4/63 (6.35%)  6
Tooth infection  1  2/63 (3.17%)  2
Upper respiratory infection  1  9/63 (14.29%)  14
Urinary tract infection  1  2/63 (3.17%)  3
Vaginal infection  1  1/63 (1.59%)  1
Injury, poisoning and procedural complications   
Bruising  1  2/63 (3.17%)  6
Investigations   
Alanine aminotransferase increased  1  26/63 (41.27%)  85
Alkaline phosphatase increased  1  11/63 (17.46%)  32
Aspartate aminotransferase increased  1  19/63 (30.16%)  49
Blood bilirubin increased  1  10/63 (15.87%)  21
CD4 lymphocytes decreased  1  1/63 (1.59%)  1
Cholesterol high  1  2/63 (3.17%)  2
Creatinine increased  1  3/63 (4.76%)  9
Hemoglobin increased  1  1/63 (1.59%)  2
Lymphocyte count decreased  1  37/63 (58.73%)  150
Neutrophil count decreased  1  32/63 (50.79%)  134
Platelet count decreased  1  26/63 (41.27%)  103
Weight gain  1  2/63 (3.17%)  9
Weight loss  1  4/63 (6.35%)  16
White blood cell decreased  1  26/63 (41.27%)  141
Metabolism and nutrition disorders   
Acidosis  1  1/63 (1.59%)  1
Anorexia  1  6/63 (9.52%)  8
Hyperglycemia  1  21/63 (33.33%)  67
Hyperkalemia  1  3/63 (4.76%)  3
Hypernatremia  1  2/63 (3.17%)  2
Hyperuricemia  1  3/63 (4.76%)  4
Hypoalbuminemia  1  7/63 (11.11%)  17
Hypocalcemia  1  10/63 (15.87%)  24
Hypoglycemia  1  8/63 (12.70%)  20
Hypokalemia  1  4/63 (6.35%)  12
Hyponatremia  1  4/63 (6.35%)  13
Hypophosphatemia  1  5/63 (7.94%)  21
Obesity  1  3/63 (4.76%)  23
Musculoskeletal and connective tissue disorders   
Arthralgia  1  12/63 (19.05%)  28
Back pain  1  8/63 (12.70%)  22
Bone pain  1  2/63 (3.17%)  2
Chest wall pain  1  2/63 (3.17%)  3
Flank pain  1  2/63 (3.17%)  3
Generalized muscle weakness  1  3/63 (4.76%)  4
Joint range of motion decreased  1  1/63 (1.59%)  2
Muscle weakness lower limb  1  1/63 (1.59%)  4
Musculoskeletal and connective tissue disorder - Other  1  2/63 (3.17%)  13
Myalgia  1  9/63 (14.29%)  19
Neck pain  1  8/63 (12.70%)  16
Pain in extremity  1  7/63 (11.11%)  15
Nervous system disorders   
Dizziness  1  6/63 (9.52%)  6
Dysgeusia  1  5/63 (7.94%)  5
Extrapyramidal disorder  1  1/63 (1.59%)  1
Headache  1  12/63 (19.05%)  26
Intracranial hemorrhage  1  1/63 (1.59%)  1
Memory impairment  1  1/63 (1.59%)  1
Paresthesia  1  3/63 (4.76%)  4
Peripheral motor neuropathy  1  1/63 (1.59%)  2
Peripheral sensory neuropathy  1  7/63 (11.11%)  22
Sinus pain  1  1/63 (1.59%)  1
Tremor  1  3/63 (4.76%)  8
Psychiatric disorders   
Agitation  1  1/63 (1.59%)  1
Anxiety  1  9/63 (14.29%)  25
Depression  1  6/63 (9.52%)  20
Insomnia  1  11/63 (17.46%)  29
Libido decreased  1  1/63 (1.59%)  1
Restlessness  1  1/63 (1.59%)  1
Renal and urinary disorders   
Acute kidney injury  1  1/63 (1.59%)  2
Renal and urinary disorders - Other  1  1/63 (1.59%)  2
Urinary frequency  1  2/63 (3.17%)  3
Urinary retention  1  1/63 (1.59%)  1
Reproductive system and breast disorders   
Erectile dysfunction  1  1/63 (1.59%)  1
Pelvic pain  1  1/63 (1.59%)  1
Penile pain  1  1/63 (1.59%)  1
Reproductive system and breast disorders - Other  1  1/63 (1.59%)  2
Vaginal hemorrhage  1  1/63 (1.59%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  4/63 (6.35%)  7
Cough  1  10/63 (15.87%)  27
Dyspnea  1  9/63 (14.29%)  23
Hoarseness  1  1/63 (1.59%)  2
Nasal congestion  1  5/63 (7.94%)  10
Pharyngolaryngeal pain  1  1/63 (1.59%)  1
Pleuritic pain  1  1/63 (1.59%)  1
Postnasal drip  1  1/63 (1.59%)  5
Productive cough  1  1/63 (1.59%)  2
Sleep apnea  1  1/63 (1.59%)  1
Sore throat  1  2/63 (3.17%)  2
Wheezing  1  1/63 (1.59%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  1/63 (1.59%)  1
Dry skin  1  9/63 (14.29%)  15
Hyperhidrosis  1  5/63 (7.94%)  19
Pruritus  1  11/63 (17.46%)  17
Purpura  1  1/63 (1.59%)  1
Rash acneiform  1  3/63 (4.76%)  4
Rash maculo-papular  1  29/63 (46.03%)  67
Scalp pain  1  1/63 (1.59%)  1
Skin and subcutaneous tissue disorders - Other  1  7/63 (11.11%)  9
Skin ulceration  1  1/63 (1.59%)  3
Urticaria  1  1/63 (1.59%)  1
Vascular disorders   
Flushing  1  2/63 (3.17%)  2
Hypertension  1  10/63 (15.87%)  32
Phlebitis  1  1/63 (1.59%)  1
Thromboembolic event  1  3/63 (4.76%)  4
Vasculitis  1  1/63 (1.59%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Peter Martin, M.D.
Organization: Weill Cornell Medical College
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01145495     History of Changes
Other Study ID Numbers: NCI-2011-02047
NCI-2011-02047 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000675161
CALGB 50803 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-50803 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: June 15, 2010
First Posted: June 16, 2010
Results First Submitted: January 6, 2014
Results First Posted: February 20, 2014
Last Update Posted: June 14, 2019