Trial Outcomes & Findings for Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL) (NCT NCT00426855)

Last Updated: 2015-04-03

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Three weeks after treatment termination

Results posted on

2015-04-03

Twelve consecutive patients of a medical clinic were included in the trial.

Participant milestones
Measure	Group 1 Bortezomib, Bendamustine, NHL, combination chemotherapy
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL)

Baseline characteristics by cohort
Measure	Group 1 n=12 Participants Bortezomib, Bendamustin, combination chemotherapy in nhl
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	8 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants

Timeframe: Three weeks after treatment termination

Outcome measures
Measure	Group 1 n=12 Participants NHL treated with combination chemotherapy of bendamustin and bortezomib
Optimal Bendamustine Dosage for Further Studies	60 mg/m^2

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events
Measure	Group 1 n=12 participants at risk NHL Patients treated with combination of bendamustine and bortezomib
Blood and lymphatic system disorders Thrombocytopenia	8.3% 1/12 • Number of events 1

Other adverse events
Measure	Group 1 n=12 participants at risk NHL Patients treated with combination of bendamustine and bortezomib
Gastrointestinal disorders Diarrhea	83.3% 10/12 • Number of events 10
Gastrointestinal disorders Nausea	66.7% 8/12 • Number of events 8
Gastrointestinal disorders Vomiting	50.0% 6/12 • Number of events 6
Cardiac disorders Dehydration	16.7% 2/12 • Number of events 2
Gastrointestinal disorders Stomatitis	8.3% 1/12 • Number of events 1
Psychiatric disorders Fatigue	50.0% 6/12 • Number of events 6
Nervous system disorders Neuropathy, motor	8.3% 1/12 • Number of events 1
Nervous system disorders Neuropathy, sensory	16.7% 2/12 • Number of events 2
Musculoskeletal and connective tissue disorders Muscle weakness	8.3% 1/12 • Number of events 1
Gastrointestinal disorders Hemorrhage, gastrointestinal	8.3% 1/12 • Number of events 1
Blood and lymphatic system disorders Anemia	8.3% 1/12 • Number of events 1
Blood and lymphatic system disorders Leukopenia	41.7% 5/12 • Number of events 5
Blood and lymphatic system disorders Neutropenia	16.7% 2/12 • Number of events 2

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