Trial Outcomes & Findings for Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplant in Treating Patients With Lymphoma (NCT NCT00039195)
NCT ID: NCT00039195
Last Updated: 2016-08-10
Results Overview
Kaplan-Meier estimates will be used to verify the progression free survival.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
2 years
Results posted on
2016-08-10
Participant Flow
Participant milestones
| Measure |
Induction R-CHOPac Therapy
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
|
|---|---|
|
Overall Study
STARTED
|
98
|
|
Overall Study
COMPLETED
|
98
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy and Rituximab With or Without Total-Body Irradiation and Peripheral Stem Cell Transplant in Treating Patients With Lymphoma
Baseline characteristics by cohort
| Measure |
Induction R-CHOPac Therapy
n=98 Participants
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsKaplan-Meier estimates will be used to verify the progression free survival.
Outcome measures
| Measure |
Induction R-CHOPac Therapy
n=98 Participants
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
|
|---|---|
|
Progression Free Survival
|
79 percentage of patients progression free
Interval 69.0 to 89.0
|
Adverse Events
Induction R-CHOPac Therapy
Serious events: 20 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction R-CHOPac Therapy
n=98 participants at risk
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
1.0%
1/98 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arachnoiditis
|
1.0%
1/98 • Number of events 1
|
|
General disorders
Constitutional symptoms, other
|
1.0%
1/98 • Number of events 1
|
|
Nervous system disorders
Delusions
|
1.0%
1/98 • Number of events 1
|
|
General disorders
Febrile neutropenia
|
8.2%
8/98 • Number of events 8
|
|
General disorders
Fever
|
1.0%
1/98 • Number of events 1
|
|
Gastrointestinal disorders
GI, other
|
2.0%
2/98 • Number of events 2
|
|
General disorders
Headache
|
1.0%
1/98 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin (Hgb)
|
1.0%
1/98 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemorrhage, other
|
1.0%
1/98 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
2.0%
2/98 • Number of events 2
|
|
Gastrointestinal disorders
Ileus (or neuroconstipation)
|
1.0%
1/98 • Number of events 1
|
|
Infections and infestations
Infection without neutropenia
|
3.1%
3/98 • Number of events 3
|
|
General disorders
Radiation mucositis
|
1.0%
1/98 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.0%
1/98 • Number of events 1
|
|
Nervous system disorders
Neuropathy-sensory
|
1.0%
1/98 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils
|
2.0%
2/98 • Number of events 2
|
|
Gastrointestinal disorders
Pain - Stomach
|
1.0%
1/98 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelets
|
2.0%
2/98 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary, other
|
1.0%
1/98 • Number of events 1
|
|
Cardiac disorders
Supravent arrhythmia
|
1.0%
1/98 • Number of events 1
|
|
General disorders
Syncope
|
1.0%
1/98 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Thrombosis
|
4.1%
4/98 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/98 • Number of events 1
|
Other adverse events
| Measure |
Induction R-CHOPac Therapy
n=98 participants at risk
Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
|
|---|---|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
8.2%
8/98 • Number of events 8
|
|
Metabolism and nutrition disorders
Bilirubin
|
20.4%
20/98 • Number of events 20
|
|
Metabolism and nutrition disorders
Creatinine
|
13.3%
13/98 • Number of events 13
|
|
Blood and lymphatic system disorders
Hemoglobin (Hgb)
|
90.8%
89/98 • Number of events 89
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
80.6%
79/98 • Number of events 79
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.2%
9/98 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.3%
16/98 • Number of events 16
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
41.8%
41/98 • Number of events 41
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.2%
10/98 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.2%
12/98 • Number of events 12
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.2%
10/98 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.2%
10/98 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.7%
33/98 • Number of events 33
|
|
Infections and infestations
Infection without neutropenia
|
5.1%
5/98 • Number of events 5
|
|
Blood and lymphatic system disorders
Leukocytes
|
69.4%
68/98 • Number of events 68
|
|
Blood and lymphatic system disorders
Lymphopenia
|
95.9%
94/98 • Number of events 94
|
|
Blood and lymphatic system disorders
Neutrophils
|
65.3%
64/98 • Number of events 64
|
|
Blood and lymphatic system disorders
Platelets
|
71.4%
70/98 • Number of events 70
|
|
Blood and lymphatic system disorders
Prothrombin time (PT)
|
9.2%
9/98 • Number of events 9
|
|
Blood and lymphatic system disorders
Partial thromboplastin time (PTT)
|
15.3%
15/98 • Number of events 15
|
|
Blood and lymphatic system disorders
SGOT (AST)
|
22.4%
22/98 • Number of events 22
|
|
Blood and lymphatic system disorders
SGPT (ALT)
|
30.6%
30/98 • Number of events 30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place