Trial Outcomes & Findings for Rituximab, Cyclophosphamide, and Pegfilgrastim in Treating Patients With Leukemia or Non-Hodgkin's Lymphoma (NCT NCT00278161)
NCT ID: NCT00278161
Last Updated: 2018-11-05
Results Overview
Median days to neutrophil and platelet recovery. Neutrophil recovery is defined as absolute neutrophil count \>= 500 cells per microliter; platelet recovery is defined as untransfused platelet count \>= 20 \* 10\^9 cells per liter.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
94 participants
Primary outcome timeframe
Up to 43 days
Results posted on
2018-11-05
Participant Flow
16 participants were screen failures. IRB allowed 3 of those participants to be analyzed along with the 78 who were treated as part of the study. Because the 3 additional participants received the exact same protocol intervention, the total population for analysis purposes is 81.
Participant milestones
| Measure |
R-HiCy
Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.
Rituximab: 375 mg/m\^2/day on Days 1, 4, 8, 11, 45, and 52.
Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18.
|
|---|---|
|
Overall Study
STARTED
|
81
|
|
Overall Study
COMPLETED
|
70
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
R-HiCy
Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.
Rituximab: 375 mg/m\^2/day on Days 1, 4, 8, 11, 45, and 52.
Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18.
|
|---|---|
|
Overall Study
Death
|
11
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
R-HiCy
n=81 Participants
Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.
Rituximab: 375 mg/m\^2/day on Days 1, 4, 8, 11, 45, and 52.
Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=81 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=81 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=81 Participants
|
|
Sex/Gender, Customized
Female
|
17 Participants
n=81 Participants
|
|
Sex/Gender, Customized
Male
|
59 Participants
n=81 Participants
|
|
Sex/Gender, Customized
Unknown
|
5 Participants
n=81 Participants
|
PRIMARY outcome
Timeframe: Up to 43 daysMedian days to neutrophil and platelet recovery. Neutrophil recovery is defined as absolute neutrophil count \>= 500 cells per microliter; platelet recovery is defined as untransfused platelet count \>= 20 \* 10\^9 cells per liter.
Outcome measures
| Measure |
R-HiCy
n=81 Participants
Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.
Rituximab: 375 mg/m\^2/day on Days 1, 4, 8, 11, 45, and 52.
Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18.
|
|---|---|
|
Engraftment
Neutrophil
|
15 days
Interval 11.0 to 32.0
|
|
Engraftment
Platelet
|
15 days
Interval 0.0 to 43.0
|
PRIMARY outcome
Timeframe: 5 yearsNumber of participants who died for reasons related to protocol treatment.
Outcome measures
| Measure |
R-HiCy
n=81 Participants
Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.
Rituximab: 375 mg/m\^2/day on Days 1, 4, 8, 11, 45, and 52.
Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18.
|
|---|---|
|
Non-relapse Mortality
|
0 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Participants were split into two populations for this outcome only: mantle-cell lymphoma and other low-grade B-cell tumors.
Percentage of participants alive without disease relapse.
Outcome measures
| Measure |
R-HiCy
n=81 Participants
Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.
Rituximab: 375 mg/m\^2/day on Days 1, 4, 8, 11, 45, and 52.
Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18.
|
|---|---|
|
Event-free Survival
Mantle-cell lymphoma
|
39 percentage of participants
|
|
Event-free Survival
Other low-grade B-cell tumors
|
40 percentage of participants
|
Adverse Events
R-HiCy
Serious events: 15 serious events
Other events: 64 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
R-HiCy
n=81 participants at risk
Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.
Rituximab: 375 mg/m\^2/day on Days 1, 4, 8, 11, 45, and 52.
Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
1.2%
1/81 • Number of events 1 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Infections and infestations
Bacteremia
|
2.5%
2/81 • Number of events 2 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/81 • Number of events 1 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
General disorders
Dehydration
|
1.2%
1/81 • Number of events 1 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Infections and infestations
Febrile neutropenia
|
7.4%
6/81 • Number of events 6 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
General disorders
Fever
|
1.2%
1/81 • Number of events 1 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Cardiac disorders
Hypotension
|
1.2%
1/81 • Number of events 1 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Infections and infestations
Infection (unspecified)
|
1.2%
1/81 • Number of events 1 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Investigations
Lipase elevated
|
1.2%
1/81 • Number of events 1 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Musculoskeletal and connective tissue disorders
Pain - wrist
|
1.2%
1/81 • Number of events 1 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Blood and lymphatic system disorders
Secondary malignancy - acute myeloid leukemia
|
1.2%
1/81 • Number of events 1 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Nervous system disorders
Syncope
|
1.2%
1/81 • Number of events 1 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
Other adverse events
| Measure |
R-HiCy
n=81 participants at risk
Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.
Pegfilgrastim: 6 mg SQ 24-48 hours after last dose of cyclophosphamide.
Rituximab: 375 mg/m\^2/day on Days 1, 4, 8, 11, 45, and 52.
Cyclophosphamide: 50 mg/kg/day on Days 15, 16, 17, and 18.
|
|---|---|
|
Investigations
ALT high
|
11.1%
9/81 • Number of events 18 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Investigations
Anemia
|
9.9%
8/81 • Number of events 25 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Gastrointestinal disorders
Anorexia
|
21.0%
17/81 • Number of events 18 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Psychiatric disorders
Anxiety
|
12.3%
10/81 • Number of events 10 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Investigations
AST high
|
8.6%
7/81 • Number of events 12 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Gastrointestinal disorders
Bloating
|
4.9%
4/81 • Number of events 4 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
General disorders
Chills
|
4.9%
4/81 • Number of events 4 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Gastrointestinal disorders
Constipation
|
12.3%
10/81 • Number of events 10 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
General disorders
Cough
|
12.3%
10/81 • Number of events 10 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Psychiatric disorders
Depression
|
6.2%
5/81 • Number of events 5 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Gastrointestinal disorders
Diarrhea
|
25.9%
21/81 • Number of events 22 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Nervous system disorders
Dizziness
|
13.6%
11/81 • Number of events 11 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Cardiac disorders
Edema
|
6.2%
5/81 • Number of events 5 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
General disorders
Fatigue
|
37.0%
30/81 • Number of events 33 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Infections and infestations
Febrile neutropenia
|
12.3%
10/81 • Number of events 10 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Infections and infestations
Fever
|
14.8%
12/81 • Number of events 15 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
General disorders
Headache
|
19.8%
16/81 • Number of events 21 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Vascular disorders
Hemorrhoids
|
6.2%
5/81 • Number of events 5 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Gastrointestinal disorders
Hiccups
|
6.2%
5/81 • Number of events 5 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Investigations
Hyperglycemia
|
6.2%
5/81 • Number of events 23 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Cardiac disorders
Hypertension
|
9.9%
8/81 • Number of events 8 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Investigations
Hyponatremia
|
4.9%
4/81 • Number of events 7 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Cardiac disorders
Hypotension
|
16.0%
13/81 • Number of events 14 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
General disorders
Insomnia
|
14.8%
12/81 • Number of events 12 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Investigations
Leukopenia
|
33.3%
27/81 • Number of events 57 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Nervous system disorders
Lightheadedness
|
9.9%
8/81 • Number of events 8 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.9%
8/81 • Number of events 8 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.9%
8/81 • Number of events 8 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Gastrointestinal disorders
Nausea
|
55.6%
45/81 • Number of events 59 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Nervous system disorders
Neuropathy
|
16.0%
13/81 • Number of events 14 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Investigations
Neutropenia
|
39.5%
32/81 • Number of events 45 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Cardiac disorders
Orthostatic hypotension
|
6.2%
5/81 • Number of events 6 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
General disorders
Pain - abdomen
|
6.2%
5/81 • Number of events 5 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Musculoskeletal and connective tissue disorders
Pain - back
|
6.2%
5/81 • Number of events 5 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Musculoskeletal and connective tissue disorders
Pain - bone
|
7.4%
6/81 • Number of events 6 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
General disorders
Pain - central catheter site
|
7.4%
6/81 • Number of events 6 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Musculoskeletal and connective tissue disorders
Pain - hip
|
7.4%
6/81 • Number of events 6 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Skin and subcutaneous tissue disorders
Pain - mouth
|
12.3%
10/81 • Number of events 10 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.2%
22/81 • Number of events 26 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
General disorders
Rigors
|
7.4%
6/81 • Number of events 6 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
General disorders
Diaphoresis
|
4.9%
4/81 • Number of events 4 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Cardiac disorders
Tachycardia
|
8.6%
7/81 • Number of events 8 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Investigations
Thrombocytopenia
|
39.5%
32/81 • Number of events 100 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Renal and urinary disorders
Urinary frequency
|
16.0%
13/81 • Number of events 14 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
Gastrointestinal disorders
Vomiting
|
40.7%
33/81 • Number of events 40 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
|
General disorders
Weight gain
|
4.9%
4/81 • Number of events 4 • Up to 1 year
Adverse events were assessed at least weekly through Day 60, then at Day 180 and one year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place