Trial Outcomes & Findings for Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma (NCT NCT01029730)
NCT ID: NCT01029730
Last Updated: 2016-08-19
Results Overview
Percentage of patients experiencing a complete response (CR) per RECIST. CR = disappearance of all target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
18 months
Results posted on
2016-08-19
Participant Flow
Participant milestones
| Measure |
Bendamustine/Bortezomib/Rituximab
Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1
|
|---|---|
|
Combination Therapy
STARTED
|
55
|
|
Combination Therapy
COMPLETED
|
39
|
|
Combination Therapy
NOT COMPLETED
|
16
|
|
Maintenance Therapy
STARTED
|
37
|
|
Maintenance Therapy
COMPLETED
|
14
|
|
Maintenance Therapy
NOT COMPLETED
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma
Baseline characteristics by cohort
| Measure |
Bendamustine/Bortezomib/Rituximab
n=55 Participants
Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1
|
|---|---|
|
Age, Continuous
|
64 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: All evaluable patients
Percentage of patients experiencing a complete response (CR) per RECIST. CR = disappearance of all target lesions.
Outcome measures
| Measure |
Bendamustine/Bortezomib/Rituximab
n=51 Participants
Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1
|
|---|---|
|
Complete Response Rate
|
65 percentage of evaluable participants
|
SECONDARY outcome
Timeframe: At 3 and 6 months during treatment, then 6 months post-treatment.Population: All patients evaluable for response.
The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Bendamustine/Bortezomib/Rituximab
n=51 Participants
Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1
|
|---|---|
|
Overall Response Rate
|
94 percentage of evaluable participants
|
SECONDARY outcome
Timeframe: at 3 and 6 months, then every 3 months post-treatment for 1 year and every 6 months thereafter until disease progression; projected 2 years.The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Bendamustine/Bortezomib/Rituximab
n=55 Participants
Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1
|
|---|---|
|
Median Progression-free Survival
|
NA months
Median PFS was not reached
|
SECONDARY outcome
Timeframe: Days 1,8, and 15 of each 28-day cycle for 6 months, then every 3 months for a year, projected 2 years.Population: All patients
Toxicity grades will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. Includes adverse events occurring in \>1 patient
Outcome measures
| Measure |
Bendamustine/Bortezomib/Rituximab
n=55 Participants
Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1
|
|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety.
Leukopenia
|
16 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety.
Neutropenia
|
16 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety.
Lymphopenia
|
9 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety.
Thrombocytopenia
|
4 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety.
Anemia
|
3 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety.
Peripheral Neuropathy
|
5 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety.
Diarrhea
|
4 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety.
Fatigue
|
4 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety.
Nausea/Vomiting
|
3 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety.
Cough
|
2 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety.
Rash
|
2 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety.
Syncope
|
2 participants
|
|
Number of Participants With Adverse Events as a Measure of Safety.
Hypocalcemia/Hyponatremia
|
2 participants
|
Adverse Events
Bendamustine/Bortezomib/Rituximab
Serious events: 11 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bendamustine/Bortezomib/Rituximab
n=55 participants at risk
Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
1/55 • 5 years
|
|
Cardiac disorders
Atrial Fibrillation
|
1.8%
1/55 • 5 years
|
|
Cardiac disorders
Cardiac disorders - other, left ventricular diastolic dysfunction
|
1.8%
1/55 • 5 years
|
|
Cardiac disorders
Cardiac disorders - Other, tachycardia
|
1.8%
1/55 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.8%
1/55 • 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
1.8%
1/55 • 5 years
|
|
General disorders
Fever
|
1.8%
1/55 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, bowel perforation
|
1.8%
1/55 • 5 years
|
|
Infections and infestations
Hepatitis viral
|
1.8%
1/55 • 5 years
|
|
Infections and infestations
Infections and infestations - Other, Perisigmoid abscess
|
1.8%
1/55 • 5 years
|
|
Infections and infestations
Infections and infestations - Other, Varicella
|
1.8%
1/55 • 5 years
|
|
General disorders
Infusion Related Reaction
|
1.8%
1/55 • 5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
1.8%
1/55 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.6%
2/55 • 5 years
|
|
Infections and infestations
Skin Infection
|
1.8%
1/55 • 5 years
|
|
Nervous system disorders
Tremor
|
1.8%
1/55 • 5 years
|
Other adverse events
| Measure |
Bendamustine/Bortezomib/Rituximab
n=55 participants at risk
Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.
Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles
Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles
Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1
|
|---|---|
|
General disorders
Fatigue
|
87.3%
48/55 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
70.9%
39/55 • 5 years
|
|
Investigations
Platelet Count Decreased
|
61.8%
34/55 • 5 years
|
|
Investigations
White Blood Cell Decreased
|
54.5%
30/55 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
52.7%
29/55 • 5 years
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
52.7%
29/55 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
45.5%
25/55 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
45.5%
25/55 • 5 years
|
|
Investigations
Neutrophil Count Decreased
|
45.5%
25/55 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
41.8%
23/55 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
41.8%
23/55 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
38.2%
21/55 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
32.7%
18/55 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
32.7%
18/55 • 5 years
|
|
General disorders
Edema
|
27.3%
15/55 • 5 years
|
|
Psychiatric disorders
Insomnia
|
27.3%
15/55 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
25.5%
14/55 • 5 years
|
|
Nervous system disorders
Dizziness
|
25.5%
14/55 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.6%
13/55 • 5 years
|
|
Investigations
Lymphocyte Count Decreased
|
21.8%
12/55 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
21.8%
12/55 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
21.8%
12/55 • 5 years
|
|
General disorders
Fever
|
20.0%
11/55 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
11/55 • 5 years
|
|
General disorders
Chills
|
18.2%
10/55 • 5 years
|
|
Nervous system disorders
Headache
|
18.2%
10/55 • 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
16.4%
9/55 • 5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.4%
9/55 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.4%
9/55 • 5 years
|
|
Gastrointestinal disorders
Mucositis
|
14.5%
8/55 • 5 years
|
|
General disorders
Pain
|
14.5%
8/55 • 5 years
|
|
Nervous system disorders
Dysgeusia
|
14.5%
8/55 • 5 years
|
|
Infections and infestations
Infections And Infestations - Other, Herpes Zoster
|
14.5%
8/55 • 5 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.7%
7/55 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
12.7%
7/55 • 5 years
|
|
Immune system disorders
Allergic Reaction
|
10.9%
6/55 • 5 years
|
|
Infections and infestations
Infections And Infestations - Other, Unspecified
|
10.9%
6/55 • 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.9%
6/55 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.9%
6/55 • 5 years
|
|
Psychiatric disorders
Anxiety
|
10.9%
6/55 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
10.9%
6/55 • 5 years
|
|
Investigations
Alanine Aminotransferase Increased
|
10.9%
6/55 • 5 years
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
5/55 • 5 years
|
|
Investigations
Alkaline Phosphatase Increased
|
9.1%
5/55 • 5 years
|
|
Investigations
Aspartate Aminotransferase Increased
|
9.1%
5/55 • 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.1%
5/55 • 5 years
|
|
Psychiatric disorders
Depression
|
9.1%
5/55 • 5 years
|
|
Vascular disorders
Hypertension
|
9.1%
5/55 • 5 years
|
|
Investigations
Investigations - Other, Ldh Increased
|
5.5%
3/55 • 5 years
|
|
Gastrointestinal disorders
Abdominal Distension
|
7.3%
4/55 • 5 years
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
7.3%
4/55 • 5 years
|
|
Infections and infestations
Upper Respiratory Infection
|
7.3%
4/55 • 5 years
|
|
Investigations
Weight Loss
|
7.3%
4/55 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
7.3%
4/55 • 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.3%
4/55 • 5 years
|
|
Investigations
Investigations - Other, Creatinine Decreased
|
7.3%
4/55 • 5 years
|
|
Investigations
Investigations - Other, Blood Protein Decreased
|
7.3%
4/55 • 5 years
|
|
Gastrointestinal disorders
Dry Mouth
|
5.5%
3/55 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
5.5%
3/55 • 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.5%
3/55 • 5 years
|
|
General disorders
Flu Like Symptoms
|
5.5%
3/55 • 5 years
|
|
Infections and infestations
Bronchial Infection
|
5.5%
3/55 • 5 years
|
|
Infections and infestations
Infections And Infestations - Other, Oral Infection
|
5.5%
3/55 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.5%
3/55 • 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.5%
3/55 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.5%
3/55 • 5 years
|
|
Renal and urinary disorders
Urinary Frequency
|
5.5%
3/55 • 5 years
|
|
Reproductive system and breast disorders
Pelvic Pain
|
5.5%
3/55 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders - Other, Runny Nose
|
5.5%
3/55 • 5 years
|
|
Vascular disorders
Hot Flashes
|
5.5%
3/55 • 5 years
|
|
Investigations
Investigations - Other, Blood Bicarbonate Increased
|
5.5%
3/55 • 5 years
|
|
General disorders
Injection Site Reaction
|
5.5%
3/55 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
5.5%
3/55 • 5 years
|
Additional Information
John D Hainsworth, MD
Sarah Cannon Research Institute
Phone: 1-877-691-7274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
- Publication restrictions are in place
Restriction type: OTHER