Trial Outcomes & Findings for Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma (NCT NCT00901927)
NCT ID: NCT00901927
Last Updated: 2020-04-03
Results Overview
To evaluate the complete response rate of the combination of BMR in previously untreated follicular non-Hodgkin's lymphoma. CR defined by International Working Group Criteria for Response for Non-Hodgkin's Lymphoma as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
3 months
Results posted on
2020-04-03
Participant Flow
Recruitment Period: May 12, 2009 to June 30, 2011. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
Bendamustine + Mitoxantrone + Rituximab
Bendamustine, Mitoxantrone, and Rituximab, 6, 28 day cycles
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Bendamustine + Mitoxantrone + Rituximab
Bendamustine, Mitoxantrone, and Rituximab, 6, 28 day cycles
|
|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma
Baseline characteristics by cohort
| Measure |
Bendamustine + Mitoxantrone + Rituximab
n=8 Participants
Bendamustine, Mitoxantrone, and Rituximab, 6, 28 day cycles
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
69.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 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
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsTo evaluate the complete response rate of the combination of BMR in previously untreated follicular non-Hodgkin's lymphoma. CR defined by International Working Group Criteria for Response for Non-Hodgkin's Lymphoma as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms.
Outcome measures
| Measure |
Bendamustine + Mitoxantrone + Rituximab
n=8 Participants
Bendamustine, Mitoxantrone, and Rituximab, 6, 28 day cycles
|
|---|---|
|
Complete Response Rate of the Combination of BMR (Bendamustine + Mitoxantrone + Rituximab)
|
3 participants
|
SECONDARY outcome
Timeframe: 3 monthsTo evaluate the toxicity and safety of BMR in participants with untreated follicular lymphoma.
Outcome measures
| Measure |
Bendamustine + Mitoxantrone + Rituximab
n=8 Participants
Bendamustine, Mitoxantrone, and Rituximab, 6, 28 day cycles
|
|---|---|
|
Participants With Adverse Events
|
3 Participants
|
SECONDARY outcome
Timeframe: 5 monthsProgression 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 + Mitoxantrone + Rituximab
n=8 Participants
Bendamustine, Mitoxantrone, and Rituximab, 6, 28 day cycles
|
|---|---|
|
Time to Progression (TTP) for Participants Treated With BMR (Bendamustine, Mitoxantrone, and Rituximab)
|
5 months
Interval 1.0 to 9.0
|
Adverse Events
Bendamustine + Mitoxantrone + Rituximab
Serious events: 8 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bendamustine + Mitoxantrone + Rituximab
n=8 participants at risk
Bendamustine, Mitoxantrone, and Rituximab, 6, 28 day cycles
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.5%
3/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Blood and lymphatic system disorders
Hgb Decreased
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Blood and lymphatic system disorders
Leukopenia
|
100.0%
8/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Blood and lymphatic system disorders
ANC Decrease
|
75.0%
6/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
37.5%
3/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
Other adverse events
| Measure |
Bendamustine + Mitoxantrone + Rituximab
n=8 participants at risk
Bendamustine, Mitoxantrone, and Rituximab, 6, 28 day cycles
|
|---|---|
|
Nervous system disorders
Anxiety
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Cardiac disorders
Atrial fibrillation
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Gastrointestinal disorders
Cecal infection
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
General disorders
Chills
|
25.0%
2/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Cardiac disorders
Conduction disorder
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Gastrointestinal disorders
Constipation
|
62.5%
5/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
4/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Eye disorders
Dry eye syndrome
|
25.0%
2/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
2/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Musculoskeletal and connective tissue disorders
Edema limbs
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Eye disorders
Eye pain
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
General disorders
Fatigue
|
75.0%
6/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Endocrine disorders
Glucose intolerance
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
General disorders
Growth and Development (Other)
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
25.0%
2/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Infections and infestations
Infection (Other)
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
25.0%
2/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
General disorders
Localized edema
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Nervous system disorders
Memory impairment
|
25.0%
2/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
25.0%
2/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
8/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Nervous system disorders
Neuralgia
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Musculoskeletal and connective tissue disorders
Peripheral motor neuropathy
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Blood and lymphatic system disorders
Petechiae
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
2/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Infections and infestations
Vaginal infection
|
12.5%
1/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Eye disorders
Vision blurred
|
25.0%
2/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
|
Eye disorders
Watering eyes
|
25.0%
2/8 • Adverse event collection through each 28 day cycle, up to 6 cycles or 180 days.
|
Additional Information
Nathan Fowler/Clinical Professor, Lymphoma-Myeloma
The University of Texas (UT) MD Anderson Cancer Center
Phone: (832) 671-3018
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place