Trial Outcomes & Findings for Bortezomib and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorders (NCT NCT00869323)
NCT ID: NCT00869323
Last Updated: 2017-12-05
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Day 1 to 2 Years Post Treatment
Results posted on
2017-12-05
Participant Flow
Participant milestones
| Measure |
Treated Study Participants
Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles.
|
|---|---|
|
Induction Therapy
STARTED
|
3
|
|
Induction Therapy
COMPLETED
|
3
|
|
Induction Therapy
NOT COMPLETED
|
0
|
|
Maintenance Therapy
STARTED
|
2
|
|
Maintenance Therapy
COMPLETED
|
1
|
|
Maintenance Therapy
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treated Study Participants
Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles.
|
|---|---|
|
Maintenance Therapy
concurrent illness
|
1
|
Baseline Characteristics
Bortezomib and Rituximab in Treating Patients With Post-Transplant Lymphoproliferative Disorders
Baseline characteristics by cohort
| Measure |
Treated Study Participants
n=3 Participants
Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 2 Years Post TreatmentOutcome measures
| Measure |
Treated Study Participants
n=3 Participants
Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles.
|
|---|---|
|
Number of Patients With Overall (Complete and Partial) Response Rates
|
2 participants
|
SECONDARY outcome
Timeframe: Day 1 to 8 Months Post TreatmentPopulation: Both of the participants who responded to treatment were in remission at last contact or death.
Outcome measures
| Measure |
Treated Study Participants
n=2 Participants
Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles.
|
|---|---|
|
Remission Duration Among Patients Who Respond to Treatment
|
45 months
Interval 22.0 to 68.0
|
SECONDARY outcome
Timeframe: Day 1 to Time of Disease ProgressionPopulation: Two participants had a complete response at the time they completed the study and were not included in this outcome measure.
Outcome measures
| Measure |
Treated Study Participants
n=1 Participants
Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles.
|
|---|---|
|
Time to Treatment Failure
|
1 months
|
SECONDARY outcome
Timeframe: at 2 yearsOutcome measures
| Measure |
Treated Study Participants
n=3 Participants
Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles.
|
|---|---|
|
Relapse-free Survival
|
2 participants
|
SECONDARY outcome
Timeframe: at 2 yearsOutcome measures
| Measure |
Treated Study Participants
n=3 Participants
Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles.
|
|---|---|
|
Overall Survival
|
1 participants
|
Adverse Events
Treated Study Participants
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treated Study Participants
n=3 participants at risk
Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles.
|
|---|---|
|
General disorders
Fever
|
33.3%
1/3
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3
|
|
Renal and urinary disorders
Renal failure
|
33.3%
1/3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3
|
|
Vascular disorders
Hypertension
|
33.3%
1/3
|
|
Musculoskeletal and connective tissue disorders
Myoclonus
|
33.3%
1/3
|
|
Nervous system disorders
Confusion
|
33.3%
1/3
|
|
Nervous system disorders
Neuropathic pain
|
33.3%
1/3
|
|
Nervous system disorders
Psychosis
|
33.3%
1/3
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
33.3%
1/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
33.3%
1/3
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3
|
|
Nervous system disorders
Delerium
|
33.3%
1/3
|
|
Nervous system disorders
Seizure
|
33.3%
1/3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
33.3%
1/3
|
Other adverse events
| Measure |
Treated Study Participants
n=3 participants at risk
Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).
Induction Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.
Single Agent Bortezomib bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.
If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.
Maintenance Therapy:
rituximab: 375 mg/m\^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m\^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles.
|
|---|---|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3
|
|
General disorders
Fever
|
33.3%
1/3
|
|
Gastrointestinal disorders
Dehydration
|
33.3%
1/3
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
33.3%
1/3
|
|
Musculoskeletal and connective tissue disorders
Myoclonus
|
33.3%
1/3
|
|
Nervous system disorders
Confusion
|
33.3%
1/3
|
|
Nervous system disorders
Neuropathic pain
|
33.3%
1/3
|
|
Nervous system disorders
Psychosis
|
33.3%
1/3
|
|
Gastrointestinal disorders
Rectal bleeding
|
33.3%
1/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
33.3%
1/3
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3
|
|
General disorders
Fatigue/malaise
|
33.3%
1/3
|
|
Renal and urinary disorders
Cystitis
|
33.3%
1/3
|
|
Respiratory, thoracic and mediastinal disorders
Lung nodule
|
33.3%
1/3
|
Additional Information
Dr. Anne Blaes
Masonic Cancer Center, University of Minnesota
Phone: 612-626-8138
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place