Trial Outcomes & Findings for Rituximab and Combination Chemotherapy Combined With Yttrium Y 90 Ibritumomab Tiuxetan in Treating Older Patients With Previously Untreated B-Cell Lymphoma (NCT NCT00058422)
NCT ID: NCT00058422
Last Updated: 2020-11-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
2 years
Results posted on
2020-11-12
Participant Flow
Participant milestones
| Measure |
R-CHOP and Ibritumomab Tiuxetan (Zevalin)
Chemotherapy: Patients receive rituximab IV over 2-5 hours, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5 or 2-6; and filgrastim (G-CSF) subcutaneously (SC) on days 7-15. Patients also receive darbepoetin alfa SC on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Radioimmunotherapy: Patients receive rituximab IV over 3-5 hours and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0.
Patients undergo gamma camera imaging at 2-24 hours and 48-72 hours after the injection of IDEC-In2B8 to observe the flow of ibritumomab tiuxetan. If the flow is deemed safe, then patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7. Quality of life is assessed at baseline, before course 5 of chemotherapy, before radioimmunotherapy, and at 3 months. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
63
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
R-CHOP and Ibritumomab Tiuxetan (Zevalin)
Chemotherapy: Patients receive rituximab IV over 2-5 hours, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5 or 2-6; and filgrastim (G-CSF) subcutaneously (SC) on days 7-15. Patients also receive darbepoetin alfa SC on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Radioimmunotherapy: Patients receive rituximab IV over 3-5 hours and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0.
Patients undergo gamma camera imaging at 2-24 hours and 48-72 hours after the injection of IDEC-In2B8 to observe the flow of ibritumomab tiuxetan. If the flow is deemed safe, then patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7. Quality of life is assessed at baseline, before course 5 of chemotherapy, before radioimmunotherapy, and at 3 months. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
|
|---|---|
|
Overall Study
Not treated
|
2
|
Baseline Characteristics
Rituximab and Combination Chemotherapy Combined With Yttrium Y 90 Ibritumomab Tiuxetan in Treating Older Patients With Previously Untreated B-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
R-CHOP and Ibritumomab Tiuxetan (Zevalin)
n=65 Participants
Chemotherapy: Patients receive rituximab IV over 2-5 hours, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5 or 2-6; and filgrastim (G-CSF) subcutaneously (SC) on days 7-15. Patients also receive darbepoetin alfa SC on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Radioimmunotherapy: Patients receive rituximab IV over 3-5 hours and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0.
Patients undergo gamma camera imaging at 2-24 hours and 48-72 hours after the injection of IDEC-In2B8 to observe the flow of ibritumomab tiuxetan. If the flow is deemed safe, then patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7. Quality of life is assessed at baseline, before course 5 of chemotherapy, before radioimmunotherapy, and at 3 months. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
|
|---|---|
|
Age, Continuous
|
75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
R-CHOP and Ibritumomab Tiuxetan (Zevalin)
n=65 Participants
Chemotherapy: Patients receive rituximab IV over 2-5 hours, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5 or 2-6; and filgrastim (G-CSF) subcutaneously (SC) on days 7-15. Patients also receive darbepoetin alfa SC on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Radioimmunotherapy: Patients receive rituximab IV over 3-5 hours and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0.
Patients undergo gamma camera imaging at 2-24 hours and 48-72 hours after the injection of IDEC-In2B8 to observe the flow of ibritumomab tiuxetan. If the flow is deemed safe, then patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7. Quality of life is assessed at baseline, before course 5 of chemotherapy, before radioimmunotherapy, and at 3 months. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
|
|---|---|
|
Overall Survival
Dead
|
32 Participants
|
|
Overall Survival
Alive
|
33 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 yearsDetermine the incidence of adverse experiences, hematologic toxicity (WBC, hemoglobin, and platelet nadirs; and transfusion requirements), cardiac toxicity (incidence of left ventricular dysfunction and cardiomyopathy by echocardiography), and the development of human antimouse antibody/human anti-chimeric antibody in patients treated with this regimen.
Outcome measures
| Measure |
R-CHOP and Ibritumomab Tiuxetan (Zevalin)
n=65 Participants
Chemotherapy: Patients receive rituximab IV over 2-5 hours, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5 or 2-6; and filgrastim (G-CSF) subcutaneously (SC) on days 7-15. Patients also receive darbepoetin alfa SC on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Radioimmunotherapy: Patients receive rituximab IV over 3-5 hours and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0.
Patients undergo gamma camera imaging at 2-24 hours and 48-72 hours after the injection of IDEC-In2B8 to observe the flow of ibritumomab tiuxetan. If the flow is deemed safe, then patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7. Quality of life is assessed at baseline, before course 5 of chemotherapy, before radioimmunotherapy, and at 3 months. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
|
|---|---|
|
Incidence of Adverse Experiences
|
65 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
Adverse Events
R-CHOP and Ibritumomab Tiuxetan (Zevalin)
Serious events: 34 serious events
Other events: 41 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
R-CHOP and Ibritumomab Tiuxetan (Zevalin)
n=65 participants at risk
Chemotherapy: Patients receive rituximab IV over 2-5 hours, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5 or 2-6; and filgrastim (G-CSF) subcutaneously (SC) on days 7-15. Patients also receive darbepoetin alfa SC on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Radioimmunotherapy: Patients receive rituximab IV over 3-5 hours and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0.
Patients undergo gamma camera imaging at 2-24 hours and 48-72 hours after the injection of IDEC-In2B8 to observe the flow of ibritumomab tiuxetan. If the flow is deemed safe, then patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7. Quality of life is assessed at baseline, before course 5 of chemotherapy, before radioimmunotherapy, and at 3 months. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
1.5%
1/65 • 2 years
|
|
Cardiac disorders
Cardiac left vent
|
6.2%
4/65 • 2 years
|
|
Cardiac disorders
Cardiovascular, Arrhythmia other
|
3.1%
2/65 • 2 years
|
|
Cardiac disorders
Cardiovascular, other
|
3.1%
2/65 • 2 years
|
|
Gastrointestinal disorders
Colititis
|
6.2%
4/65 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/65 • 2 years
|
|
Psychiatric disorders
Delusions
|
1.5%
1/65 • 2 years
|
|
Skin and subcutaneous tissue disorders
Derm, skin other
|
4.6%
3/65 • 2 years
|
|
Gastrointestinal disorders
Diarrhea (Pts w/out col)
|
1.5%
1/65 • 2 years
|
|
Nervous system disorders
Dizziness
|
1.5%
1/65 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.8%
9/65 • 2 years
|
|
General disorders
Fever
|
1.5%
1/65 • 2 years
|
|
Gastrointestinal disorders
GI, other
|
1.5%
1/65 • 2 years
|
|
Investigations
Hemoglobin (Hgb)
|
4.6%
3/65 • 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.5%
1/65 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.6%
3/65 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.5%
1/65 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.5%
1/65 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.5%
1/65 • 2 years
|
|
Vascular disorders
Hypotension
|
3.1%
2/65 • 2 years
|
|
Infections and infestations
Infection w.out neutropenia
|
20.0%
13/65 • 2 years
|
|
Infections and infestations
Infection with grade 3/4 neut
|
4.6%
3/65 • 2 years
|
|
Infections and infestations
Infection/Feb Neut-Other
|
1.5%
1/65 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
4.6%
3/65 • 2 years
|
|
Nervous system disorders
Neurology, other
|
1.5%
1/65 • 2 years
|
|
Investigations
Platelets
|
3.1%
2/65 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.6%
3/65 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary, other
|
1.5%
1/65 • 2 years
|
|
Cardiac disorders
Supravent arrhythmia
|
3.1%
2/65 • 2 years
|
|
Vascular disorders
Thrombosis
|
9.2%
6/65 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/65 • 2 years
|
Other adverse events
| Measure |
R-CHOP and Ibritumomab Tiuxetan (Zevalin)
n=65 participants at risk
Chemotherapy: Patients receive rituximab IV over 2-5 hours, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1; oral prednisone on days 1-5 or 2-6; and filgrastim (G-CSF) subcutaneously (SC) on days 7-15. Patients also receive darbepoetin alfa SC on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Radioimmunotherapy: Patients receive rituximab IV over 3-5 hours and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 0.
Patients undergo gamma camera imaging at 2-24 hours and 48-72 hours after the injection of IDEC-In2B8 to observe the flow of ibritumomab tiuxetan. If the flow is deemed safe, then patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7. Quality of life is assessed at baseline, before course 5 of chemotherapy, before radioimmunotherapy, and at 3 months. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.2%
6/65 • 2 years
|
|
Infections and infestations
Infection w.out neutropenia
|
7.7%
5/65 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
4.6%
3/65 • 2 years
|
|
Cardiac disorders
Supravent arrhythmia
|
4.6%
3/65 • 2 years
|
|
Blood and lymphatic system disorders
Hemoglobin (Hgb)
|
3.1%
2/65 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.1%
2/65 • 2 years
|
|
Infections and infestations
Infection with grade 3/4 neut
|
3.1%
2/65 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
3.1%
2/65 • 2 years
|
|
Investigations
Platelets
|
3.1%
2/65 • 2 years
|
|
Vascular disorders
Thrombosis
|
3.1%
2/65 • 2 years
|
|
Cardiac disorders
Cardiovascular, Arrhythmia other
|
1.5%
1/65 • 2 years
|
|
Gastrointestinal disorders
Colititis
|
1.5%
1/65 • 2 years
|
|
Gastrointestinal disorders
Diarrhea (Pts w/out col)
|
1.5%
1/65 • 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.5%
1/65 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.5%
1/65 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.5%
1/65 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.5%
1/65 • 2 years
|
|
Vascular disorders
Hypotension
|
1.5%
1/65 • 2 years
|
|
Infections and infestations
Infection/Feb Neut-Other
|
1.5%
1/65 • 2 years
|
|
Investigations
Lymphopenia
|
1.5%
1/65 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary, other
|
1.5%
1/65 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/65 • 2 years
|
Additional Information
Paul A. Hamlin, M.D.
Memorial Sloan Kettering Cancer Center
Phone: 646-608-1667
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place