Trial Outcomes & Findings for Bortezomib, Doxorubicin Hydrochloride Liposome, and Rituximab in Treating Patients With Diffuse Large B-Cell Lymphoma That Has Relapsed or Not Responded to Treatment (NCT NCT00851552)

NCT ID: NCT00851552

Last Updated: 2014-07-21

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: at weeks 9 and 21
• Results posted on: 2014-07-21

Participant Flow

Participant milestones

Measure	VDR: Velcade, Doxil, and Rituxan VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
Overall Study STARTED	9
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	VDR: Velcade, Doxil, and Rituxan VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
Overall Study Death	2
Overall Study Adverse Event	1
Overall Study Disease Progression	4

Baseline Characteristics

Bortezomib, Doxorubicin Hydrochloride Liposome, and Rituximab in Treating Patients With Diffuse Large B-Cell Lymphoma That Has Relapsed or Not Responded to Treatment

Baseline characteristics by cohort

Measure	VDR: Velcade, Doxil, and Rituxan n=9 Participants VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
Age, Continuous	61.78 years STANDARD_DEVIATION 18.82 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: at weeks 9 and 21

Population: Due to the study's early termination and inadequate number of patients, no patients were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Due to the study's early termination and inadequate number of patients, no patients were analyzed.

Outcome measures

Outcome data not reported

Adverse Events

VDR: Velcade, Doxil, and Rituxan

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	VDR: Velcade, Doxil, and Rituxan n=9 participants at risk VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
Cardiac disorders Myocardial infarction	11.1% 1/9 • Number of events 1
Cardiac disorders Myocardial ischaemia	11.1% 1/9 • Number of events 1
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Number of events 1
Gastrointestinal disorders Diarrhoea	11.1% 1/9 • Number of events 1
General disorders Death	22.2% 2/9 • Number of events 2
Investigations Troponin I increased	11.1% 1/9 • Number of events 1
Renal and urinary disorders Renal failure acute	11.1% 1/9 • Number of events 2
Respiratory, thoracic and mediastinal disorders Hypoxia	11.1% 1/9 • Number of events 1

Other adverse events

Measure	VDR: Velcade, Doxil, and Rituxan n=9 participants at risk VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
Blood and lymphatic system disorders Anaemia	11.1% 1/9 • Number of events 1
Blood and lymphatic system disorders Platelet disorder	11.1% 1/9 • Number of events 1
Blood and lymphatic system disorders Thrombocytopenia	22.2% 2/9 • Number of events 10
Cardiac disorders Cardiac failure congestive	11.1% 1/9 • Number of events 1
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Number of events 1
Gastrointestinal disorders Constipation	11.1% 1/9 • Number of events 1
Gastrointestinal disorders Diarrhoea	22.2% 2/9 • Number of events 5
Gastrointestinal disorders Dysphagia	11.1% 1/9 • Number of events 1
Gastrointestinal disorders Nausea	11.1% 1/9 • Number of events 1
Gastrointestinal disorders Vomiting	22.2% 2/9 • Number of events 3
General disorders Chills	22.2% 2/9 • Number of events 2
General disorders Fatigue	11.1% 1/9 • Number of events 2
General disorders Pain	11.1% 1/9 • Number of events 1
General disorders Pyrexia	22.2% 2/9 • Number of events 2
Immune system disorders Cytokine release syndrome	22.2% 2/9 • Number of events 2
Infections and infestations Sepsis	11.1% 1/9 • Number of events 1
Investigations Platelet count decreased	11.1% 1/9 • Number of events 1
Investigations Troponin increased	11.1% 1/9 • Number of events 1
Investigations Weight decreased	11.1% 1/9 • Number of events 3
Metabolism and nutrition disorders Anorexia	11.1% 1/9 • Number of events 2
Metabolism and nutrition disorders Hypercalcaemia	11.1% 1/9 • Number of events 1
Metabolism and nutrition disorders Hyperglycaemia	11.1% 1/9 • Number of events 2
Metabolism and nutrition disorders Hyponatraemia	11.1% 1/9 • Number of events 1
Musculoskeletal and connective tissue disorders Back pain	11.1% 1/9 • Number of events 1
Nervous system disorders Dysgeusia	22.2% 2/9 • Number of events 2
Nervous system disorders Neuropathy peripheral	22.2% 2/9 • Number of events 2
Respiratory, thoracic and mediastinal disorders Bronchospasm	11.1% 1/9 • Number of events 1
Respiratory, thoracic and mediastinal disorders Cough	22.2% 2/9 • Number of events 2
Respiratory, thoracic and mediastinal disorders Dyspnoea	22.2% 2/9 • Number of events 3
Skin and subcutaneous tissue disorders Pruritus	11.1% 1/9 • Number of events 1
Skin and subcutaneous tissue disorders Rash	22.2% 2/9 • Number of events 2
Vascular disorders Hypotension	11.1% 1/9 • Number of events 1

Additional Information

Senior Administrator, Compliance - Clinical Research Services

Roswell Park Cancer Institute

Phone: 716-845-2300

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place