Trial Outcomes & Findings for Rituximab, Combination Chemotherapy, and 90-Yttrium Ibritumomab Tiuxetan for Patients With Stage I or II Non-Hodgkin's Lymphoma (NCT NCT00088881)
NCT ID: NCT00088881
Last Updated: 2017-05-25
Results Overview
Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Cheson, 1999). CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization (normal limits of institutional labs) of those biochemical abnormalities (e.g., LDH) definitely attributed to NHL. CRu is defined as meeting the criteria of CR except one or more of the followings: A residual dominant node (or extra-nodal mass) that is currently \> 1.5 cm in greatest diameter that has decreased by \> 75% from baseline in the product of its diameters. Individual dominant nodes (or extra-nodal masses) that were previously confluent must have decreased by \> 75% in SPD compared with the size of the original mass. Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin
Results posted on
2017-05-25
Participant Flow
Participant milestones
| Measure |
Treatment
R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
|
|---|---|
|
Step 1 - R-CHOP
STARTED
|
62
|
|
Step 1 - R-CHOP
Eligible and Treated
|
53
|
|
Step 1 - R-CHOP
COMPLETED
|
48
|
|
Step 1 - R-CHOP
NOT COMPLETED
|
14
|
|
Step 2 - Zevalin™ Radioimmunotherapy
STARTED
|
56
|
|
Step 2 - Zevalin™ Radioimmunotherapy
Eligible and Treated
|
48
|
|
Step 2 - Zevalin™ Radioimmunotherapy
COMPLETED
|
45
|
|
Step 2 - Zevalin™ Radioimmunotherapy
NOT COMPLETED
|
11
|
|
Step 3 - Radiation Therapy
STARTED
|
1
|
|
Step 3 - Radiation Therapy
COMPLETED
|
1
|
|
Step 3 - Radiation Therapy
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Treatment
R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
|
|---|---|
|
Step 1 - R-CHOP
Patient ineligible
|
9
|
|
Step 1 - R-CHOP
Adverse Event
|
1
|
|
Step 1 - R-CHOP
Withdrawal by Subject
|
2
|
|
Step 1 - R-CHOP
Physician Decision
|
1
|
|
Step 1 - R-CHOP
Insurance company refused to cover
|
1
|
|
Step 2 - Zevalin™ Radioimmunotherapy
Patient ineligible
|
8
|
|
Step 2 - Zevalin™ Radioimmunotherapy
Other
|
3
|
Baseline Characteristics
Rituximab, Combination Chemotherapy, and 90-Yttrium Ibritumomab Tiuxetan for Patients With Stage I or II Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment
n=53 Participants
R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium ZevalinPopulation: Eligible and treated patients
Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma (Cheson, 1999). CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization (normal limits of institutional labs) of those biochemical abnormalities (e.g., LDH) definitely attributed to NHL. CRu is defined as meeting the criteria of CR except one or more of the followings: A residual dominant node (or extra-nodal mass) that is currently \> 1.5 cm in greatest diameter that has decreased by \> 75% from baseline in the product of its diameters. Individual dominant nodes (or extra-nodal masses) that were previously confluent must have decreased by \> 75% in SPD compared with the size of the original mass. Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).
Outcome measures
| Measure |
Treatment
n=53 Participants
R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
|
|---|---|
|
Complete Response (CR) +Complete Response/Uncertain (CRu) in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.
|
0.87 proportion of participants
Interval 0.75 to 0.95
|
PRIMARY outcome
Timeframe: Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium ZevalinPopulation: Eligible and treated patients.
Patients will be considered a functional CR if they meet the criteria for a CR, or if they meet the criteria for a CRu or partial response (PR) by CT and are PET negative. Please see primary outcome #1 for the definition of CR and CRu. PR is defined as: A decrease of \>50% in the SPD (sum of products of the diameters) of the six largest (or less) dominant nodes or extra-nodal masses. No increase in the size of the liver or the spleen. No unequivocal progression in any non-measurable or non-dominant site. Splenic and hepatic nodules must regress by \>50% in SPD (sum of the products of the diameters). Bone marrow assessment is not relevant for determination of a PR because it is assessable and not measurable disease. No new sites of disease.
Outcome measures
| Measure |
Treatment
n=53 Participants
R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
|
|---|---|
|
Functional CR in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.
|
0.89 proportion of participants
Interval 0.77 to 0.96
|
SECONDARY outcome
Timeframe: Assessed every 3 months for one year; every 4 months for the second year; then every 6 months for 3 years; then annually to 10 years from patient entry.Population: Eligible and treated patients
Time to treatment failure (TTF) is defined as the time from step 1 registration to disease progression or death. TTF is censored at last documented progression free for cases without progression. The 3-year TTF rate is defined as the probability of patients remaining free from treatment failure at 3 years.
Outcome measures
| Measure |
Treatment
n=53 Participants
R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
|
|---|---|
|
3-year Time to Treatment Failure (TTF) Rate
|
0.92 probability
Interval 0.84 to 1.0
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years; then annually to 10 years from patient entry.Population: Eligible and treated patients
Overall survival (OS) is defined as the time from step 1 registration to death of any cause. OS is censored at the date last known alive for cases that are alive. The 3-year OS rate is defined as the probability of patients remaining alive at 3 years.
Outcome measures
| Measure |
Treatment
n=53 Participants
R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
|
|---|---|
|
3-year Overall Survival (OS) Rate
|
0.98 probability
Interval 0.94 to 1.0
|
Adverse Events
Step 1 - R-CHOP
Serious events: 44 serious events
Other events: 62 other events
Deaths: 0 deaths
Step 2 - Zevalin™ Radioimmunotherapy
Serious events: 46 serious events
Other events: 55 other events
Deaths: 0 deaths
Step 3 - Radiation Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Step 1 - R-CHOP
n=62 participants at risk
Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
|
Step 2 - Zevalin™ Radioimmunotherapy
n=56 participants at risk
Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
|
Step 3 - Radiation Therapy
n=1 participants at risk
Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
|
|---|---|---|---|
|
Immune system disorders
Allergic reaction
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
CD4 decreased
|
0.00%
0/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.8%
1/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
8.1%
5/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.4%
3/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes decreased
|
35.5%
22/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
35.7%
20/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
41.9%
26/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
60.7%
34/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils decreased
|
43.5%
27/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
51.8%
29/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets decreased
|
8.1%
5/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
46.4%
26/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Heart block Stokes-Adams syndrome
|
0.00%
0/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
11.3%
7/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
6.5%
4/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
2/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.8%
1/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.8%
1/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.1%
10/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, lung
|
3.2%
2/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, skin
|
0.00%
0/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.8%
1/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, blood
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Acidosis
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.7%
6/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.2%
2/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.2%
2/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
4.8%
3/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.8%
1/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Psychosis
|
3.2%
2/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Syncope
|
4.8%
3/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Bladder, pain
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Face, pain
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathic, pain
|
0.00%
0/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
1.8%
1/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.2%
2/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
1.6%
1/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Step 1 - R-CHOP
n=62 participants at risk
Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
|
Step 2 - Zevalin™ Radioimmunotherapy
n=56 participants at risk
Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
|
Step 3 - Radiation Therapy
n=1 participants at risk
Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
77.4%
48/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
78.6%
44/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes decreased
|
62.9%
39/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
91.1%
51/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
80.6%
50/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
83.9%
47/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils decreased
|
45.2%
28/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
73.2%
41/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets decreased
|
32.3%
20/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
91.1%
51/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
80.6%
50/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
57.1%
32/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever w/o neutropenia
|
0.00%
0/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.4%
3/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
9.7%
6/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Rigors/chills
|
11.3%
7/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Sweating
|
8.1%
5/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
17.7%
11/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.4%
3/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
31/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
12.5%
7/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
9.7%
6/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
17.7%
11/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
22.6%
14/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.1%
4/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
56.5%
35/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
25.8%
16/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
10.7%
6/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dry mouth
|
9.7%
6/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
30.6%
19/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
|
22.6%
14/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
27.4%
17/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
59.7%
37/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
10.7%
6/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Taste disturbance
|
19.4%
12/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.4%
3/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
24.2%
15/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limb
|
9.7%
6/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
21.0%
13/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
14.3%
8/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
6.5%
4/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
14.5%
9/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.1%
4/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.4%
3/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.1%
5/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
6.5%
4/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
71.0%
44/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
28.6%
16/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.5%
4/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
11.3%
7/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-motor
|
9.7%
6/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
61.3%
38/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
17.9%
10/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdomen, pain
|
9.7%
6/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Head/headache
|
12.9%
8/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.4%
3/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
6.5%
4/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle, pain
|
14.5%
9/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.3%
7/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.9%
8/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
7.1%
4/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
|
0.00%
0/62 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
5.4%
3/56 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/1 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60