Trial Outcomes & Findings for Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation (NCT NCT00066469)
NCT ID: NCT00066469
Last Updated: 2019-08-06
Results Overview
Alive in continuous complete remission with functioning original allograft. The Event Free Survival (EFS) will be estimated by the Kaplan-Meier method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
2 years
Results posted on
2019-08-06
Participant Flow
Participant milestones
| Measure |
Cyclophosphamide, Prednisone, Rituximab
Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Cyclophosphamide, Prednisone, Rituximab
Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Lack of Efficacy
|
9
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
ineligible
|
1
|
Baseline Characteristics
Cyclophosphamide, Rituximab, and Either Prednisone or Methylprednisolone in Treating Patients With Lymphoproliferative Disease After Solid Organ Transplantation
Baseline characteristics by cohort
| Measure |
Cyclophosphamide, Prednisone, Rituximab
n=55 Participants
Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
|
|---|---|
|
Age, Categorical
<=18 years
|
54 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: One patient out of the 55 patients enrolled was ineligible for study and therefore was excluded from analysis.
Alive in continuous complete remission with functioning original allograft. The Event Free Survival (EFS) will be estimated by the Kaplan-Meier method.
Outcome measures
| Measure |
Cyclophosphamide, Prednisone, Rituximab
n=54 Participants
Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
|
|---|---|
|
Event-free Survival
|
71 percentage of participants analyzed
Interval 57.0 to 82.0
|
Adverse Events
Cyclophosphamide, Prednisone, Rituximab
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cyclophosphamide, Prednisone, Rituximab
n=54 participants at risk
Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
|
|---|---|
|
Cardiac disorders
Sinus bradycardia
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
General disorders
Death NOS
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
Other adverse events
| Measure |
Cyclophosphamide, Prednisone, Rituximab
n=54 participants at risk
Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
3/54 • Number of events 3
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
22.2%
12/54 • Number of events 12
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Cardiac disorders
Sinus tachycardia
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
2/54 • Number of events 2
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Gastrointestinal disorders
Mucositis oral
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Gastrointestinal disorders
Nausea
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
General disorders
Chills
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
General disorders
Death NOS
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
General disorders
Fever
|
3.7%
2/54 • Number of events 2
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Hepatobiliary disorders
Hepatic hemorrhage
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Hepatobiliary disorders
Hepatic necrosis
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Infections and infestations
Bronchial infection
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Infections and infestations
Catheter related infection
|
5.6%
3/54 • Number of events 3
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Infections and infestations
Enterocolitis infectious
|
3.7%
2/54 • Number of events 2
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
31.5%
17/54 • Number of events 17
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Infections and infestations
Kidney infection
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Infections and infestations
Lung infection
|
3.7%
2/54 • Number of events 2
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Infections and infestations
Peritoneal infection
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Infections and infestations
Pharyngitis
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Infections and infestations
Skin infection
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Infections and infestations
Small intestine infection
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
6/54 • Number of events 6
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Investigations
Aspartate aminotransferase increased
|
7.4%
4/54 • Number of events 4
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Investigations
Blood bilirubin increased
|
5.6%
3/54 • Number of events 3
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Investigations
Cholesterol high
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Investigations
Creatinine increased
|
7.4%
4/54 • Number of events 4
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Investigations
GGT increased
|
9.3%
5/54 • Number of events 5
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Investigations
Investigations - Other, specify
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Investigations
Lipase increased
|
3.7%
2/54 • Number of events 2
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Investigations
Neutrophil count decreased
|
27.8%
15/54 • Number of events 15
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Investigations
Platelet count decreased
|
3.7%
2/54 • Number of events 2
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Investigations
Serum amylase increased
|
3.7%
2/54 • Number of events 2
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Investigations
White blood cell decreased
|
16.7%
9/54 • Number of events 9
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Metabolism and nutrition disorders
Acidosis
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.4%
4/54 • Number of events 4
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
6/54 • Number of events 6
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.6%
3/54 • Number of events 3
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.7%
2/54 • Number of events 2
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.7%
2/54 • Number of events 2
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.7%
2/54 • Number of events 2
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
6/54 • Number of events 6
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.3%
5/54 • Number of events 5
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.7%
2/54 • Number of events 2
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Nervous system disorders
Dizziness
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Nervous system disorders
Seizure
|
5.6%
3/54 • Number of events 3
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Psychiatric disorders
Agitation
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Renal and urinary disorders
Renal hemorrhage
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
3/54 • Number of events 3
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
3/54 • Number of events 3
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Vascular disorders
Hypertension
|
1.9%
1/54 • Number of events 1
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
|
Vascular disorders
Hypotension
|
5.6%
3/54 • Number of events 3
One patient out of the 55 patients enrolled was not eligible for this study. Only eligible patients were included in the Adverse Event (AE) analysis for both Serious and Other AE events.
|
Additional Information
Results Reporting Coordinator
Children's Oncology Group
Phone: 352-273-0558
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Must obtain prior Sponsor approval.
- Publication restrictions are in place
Restriction type: OTHER