Trial Outcomes & Findings for Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma (NCT NCT00193479)
NCT ID: NCT00193479
Last Updated: 2022-03-03
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
18 Months
Results posted on
2022-03-03
Participant Flow
Forty-eight of 51 patients (94%) completed the initial three courses of rituximab/chemotherapy. Forty-four of the 48 patients (92%) received the Rituximab maintenance therapy.
Participant milestones
| Measure |
CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab
Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
|
|---|---|
|
Induction Chemotherapy
STARTED
|
51
|
|
Induction Chemotherapy
COMPLETED
|
48
|
|
Induction Chemotherapy
NOT COMPLETED
|
3
|
|
Maintenance Rituximab
STARTED
|
48
|
|
Maintenance Rituximab
COMPLETED
|
44
|
|
Maintenance Rituximab
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab
Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
|
|---|---|
|
Induction Chemotherapy
Adverse Event
|
2
|
|
Induction Chemotherapy
Disease Progression
|
1
|
|
Maintenance Rituximab
Opted for full course rituximab/chemotherapy
|
2
|
|
Maintenance Rituximab
Withdrawal by Subject
|
2
|
Baseline Characteristics
Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab
n=51 Participants
Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
|
|---|---|
|
Age, Continuous
|
78 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 MonthsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab
n=48 Participants
Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
|
|---|---|
|
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
|
81 percentage of patients
|
Adverse Events
CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab
Serious events: 24 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab
n=51 participants at risk
Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
|
|---|---|
|
Infections and infestations
Pneumonia
|
3.9%
2/51 • Number of events 2
|
|
Gastrointestinal disorders
Perforated colon
|
2.0%
1/51 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
5.9%
3/51 • Number of events 3
|
|
Nervous system disorders
CVA
|
7.8%
4/51 • Number of events 4
|
|
Infections and infestations
Infection of bilateral heel ulcer wounds
|
2.0%
1/51 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Infection, L ankle
|
2.0%
1/51 • Number of events 1
|
|
Nervous system disorders
Concussion, related to fall
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.0%
1/51 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fractured hip
|
3.9%
2/51 • Number of events 2
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
2.0%
1/51 • Number of events 1
|
|
General disorders
Fever
|
2.0%
1/51 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fractured ankle
|
2.0%
1/51 • Number of events 1
|
|
Cardiac disorders
CHF
|
2.0%
1/51 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Acute chronic fractures on lumbar spine
|
2.0%
1/51 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
3.9%
2/51 • Number of events 2
|
|
Renal and urinary disorders
Gross hematuria
|
2.0%
1/51 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulitis
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulosis
|
3.9%
2/51 • Number of events 2
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.0%
1/51 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
New primary lung cancer
|
2.0%
1/51 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
2.0%
1/51 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acute renal failure
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
2.0%
1/51 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intractable neck pain
|
2.0%
1/51 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Right lower thigh pain
|
2.0%
1/51 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
3.9%
2/51 • Number of events 2
|
|
Nervous system disorders
Intramedullary spinal cord mass
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/51 • Number of events 3
|
Other adverse events
| Measure |
CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab
n=51 participants at risk
Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
58.8%
30/51 • Number of events 152
|
|
Blood and lymphatic system disorders
Anemia
|
68.6%
35/51 • Number of events 169
|
|
Gastrointestinal disorders
Anorexia
|
56.9%
29/51 • Number of events 85
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.5%
13/51 • Number of events 42
|
|
Cardiac disorders
Cardiac Toxicity
|
15.7%
8/51 • Number of events 17
|
|
General disorders
Chills/Rigor
|
5.9%
3/51 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
41.2%
21/51 • Number of events 47
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.8%
4/51 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
23.5%
12/51 • Number of events 19
|
|
Nervous system disorders
Dizziness
|
15.7%
8/51 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
3/51 • Number of events 3
|
|
General disorders
Edema
|
15.7%
8/51 • Number of events 18
|
|
General disorders
Fatigue
|
86.3%
44/51 • Number of events 305
|
|
General disorders
Fever
|
15.7%
8/51 • Number of events 12
|
|
Nervous system disorders
Headache
|
5.9%
3/51 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.7%
8/51 • Number of events 21
|
|
Cardiac disorders
Hypertension
|
7.8%
4/51 • Number of events 4
|
|
Cardiac disorders
Hypotension
|
7.8%
4/51 • Number of events 6
|
|
Infections and infestations
Infection
|
37.3%
19/51 • Number of events 36
|
|
General disorders
Insomnia
|
11.8%
6/51 • Number of events 8
|
|
Blood and lymphatic system disorders
Leukopenia
|
49.0%
25/51 • Number of events 82
|
|
Gastrointestinal disorders
Mucositis
|
9.8%
5/51 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.6%
11/51 • Number of events 26
|
|
Gastrointestinal disorders
Nausea
|
35.3%
18/51 • Number of events 31
|
|
Nervous system disorders
Neuropathy
|
7.8%
4/51 • Number of events 6
|
|
Blood and lymphatic system disorders
Neutropenia
|
41.2%
21/51 • Number of events 54
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
13.7%
7/51 • Number of events 29
|
|
Skin and subcutaneous tissue disorders
Rash/Skin Irritation
|
15.7%
8/51 • Number of events 20
|
|
Gastrointestinal disorders
Stomatitis
|
11.8%
6/51 • Number of events 8
|
|
Gastrointestinal disorders
Taste Alteration
|
5.9%
3/51 • Number of events 13
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
27.5%
14/51 • Number of events 59
|
|
Gastrointestinal disorders
Vomiting
|
17.6%
9/51 • Number of events 13
|
|
General disorders
Weakness
|
25.5%
13/51 • Number of events 45
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER