Trial Outcomes & Findings for Ibritumomab Tiuxetan (Zevalin)+ Rituximab Maintenance (NCT NCT00582166)
NCT ID: NCT00582166
Last Updated: 2019-12-13
Results Overview
Estimate median progression free survival (PFS), where PFS is defined as the number of days from administration of Ibritumomab tiuxetan In111 (defined as day 1) until the participant develops progressive disease or death from NHL (Non-Hodgkin's Lymphoma).
TERMINATED
PHASE2
18 participants
up to 5 years, 9.5 months, from first day on treatment to last follow up
2019-12-13
Participant Flow
Participant milestones
| Measure |
Zevalin With Rituximab Maintenance
Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Zevalin With Rituximab Maintenance
Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Ineligible pathology
|
1
|
Baseline Characteristics
Ibritumomab Tiuxetan (Zevalin)+ Rituximab Maintenance
Baseline characteristics by cohort
| Measure |
Zevalin With Rituximab Maintenance
n=18 Participants
Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 5 years, 9.5 months, from first day on treatment to last follow upPopulation: The study was stopped prematurely, subjects were not followed for a full 7 years. We have data for 16 subjects, 6 experienced a progression event, 10 survived progression-free through last follow-up. Date of last follow-up is used to calculate progression-free survival for those who did not experience progression.
Estimate median progression free survival (PFS), where PFS is defined as the number of days from administration of Ibritumomab tiuxetan In111 (defined as day 1) until the participant develops progressive disease or death from NHL (Non-Hodgkin's Lymphoma).
Outcome measures
| Measure |
Zevalin With Rituximab Maintenance
n=16 Participants
Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
|
|---|---|
|
Median Progression Free Survival (PFS)
|
44.3 months
Interval 32.8 to 46.1
|
SECONDARY outcome
Timeframe: Up to 24 monthsEstimate the 24 month progression free survival (PFS), where PFS is defined as the number of days from the first Ibritumomab tiuxetan administration (day 0) to the day the patient experiences an event of disease progression (or death). PFS is summarized as the percentage of patients that survived progression free after 24 months. Progression is defined as any of the following: \- Appearances of any new lesions/sites during or after therapy. * Increase of \>/= 50% in the SPD (sum of perpendicular diameter) from nadir measurement of all involved dominant lymph nodes and liver nodules and spleen nodules or unequivocal progression in any nonmeasurable disease or nondominant site. * Increase by \> 50% in greatest diameter from nadir measurement of any previously involved dominant node \> 1.0 cm in its short axis.
Outcome measures
| Measure |
Zevalin With Rituximab Maintenance
n=16 Participants
Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
|
|---|---|
|
24-month Progression Free Survival (PFS)
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 5 years and 9.5 monthsTo estimate the Complete Response and unconfirmed Complete Response rate (assessing Ibritumomab tiuxetan). Complete response is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms, and all dominant lymph nodes and nodal masses have regressed to normal size, and complete resolution of lymphoma in the bone marrow biopsy. Unconfirmed Complete Response (CRu) defined as the above, but with either a \> 1.5cm residual node that has decreased by \>75%, and/or individual nodes that were previously confluent that have decreased by \>75% in SPD, and/or indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).
Outcome measures
| Measure |
Zevalin With Rituximab Maintenance
n=16 Participants
Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
|
|---|---|
|
Response Rates
|
44 percentage of participants
Interval 23.0 to 67.0
|
SECONDARY outcome
Timeframe: Up to 5 years and 9.5 monthsTo record the toxicities associated with this regimen.
Outcome measures
| Measure |
Zevalin With Rituximab Maintenance
n=16 Participants
Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
|
|---|---|
|
Number of Participants Experiencing Toxicities, Measured by CTCAE v3.0
|
16 Participants
|
SECONDARY outcome
Timeframe: At 12 monthsTo estimate overall survival, 95% confidence intervals will be used.
Outcome measures
| Measure |
Zevalin With Rituximab Maintenance
n=16 Participants
Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
|
|---|---|
|
Overall Survival (OS)
|
93 percentage of participants
Interval 80.0 to 100.0
|
Adverse Events
Zevalin With Rituximab Maintenance
Serious adverse events
| Measure |
Zevalin With Rituximab Maintenance
n=16 participants at risk
Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
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|---|---|
|
Infections and infestations
Infection
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes
|
12.5%
2/16 • Number of events 2
|
|
Blood and lymphatic system disorders
Platelets
|
12.5%
2/16 • Number of events 2
|
|
Blood and lymphatic system disorders
Tranfusion: Platelets
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
Zevalin With Rituximab Maintenance
n=16 participants at risk
Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
|
|---|---|
|
Ear and labyrinth disorders
Auditory/Ear - Other - Vertigo
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other - Anemia
|
56.2%
9/16 • Number of events 9
|
|
Blood and lymphatic system disorders
Leukocytes
|
93.8%
15/16 • Number of events 28
|
|
Blood and lymphatic system disorders
Lymphopenia
|
56.2%
9/16 • Number of events 37
|
|
Blood and lymphatic system disorders
Neutrophils/granulo-cytes (ANC/AGC)
|
56.2%
9/16 • Number of events 9
|
|
Blood and lymphatic system disorders
Platelets
|
81.2%
13/16 • Number of events 31
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
75.0%
12/16 • Number of events 19
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 109/L
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Insomnia
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Rigors/chills
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Weight gain
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other - Cold Sore
|
6.2%
1/16 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other - Knee Puncture
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other - Rash (erythema & scaling)
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other - Skin
|
12.5%
2/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus/Itching
|
6.2%
1/16 • Number of events 1
|
|
Endocrine disorders
Hot Flashes/flushes
|
25.0%
4/16 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
2/16 • Number of events 3
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
31.2%
5/16 • Number of events 5
|
|
Gastrointestinal disorders
Vomitting
|
12.5%
2/16 • Number of events 2
|
|
Vascular disorders
Hemmorage/Bleeding - Other - Hemmorage
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Infection - Dermatology/Skin - Skin (cellulitus)
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Infection - Other - Infection
|
18.8%
3/16 • Number of events 5
|
|
Infections and infestations
Infection - Pulmonary/Upper Respiratory - Sinus
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Infection - Pulmonary/Upper Respiratory - Upper aerodigestive NOS
|
6.2%
1/16 • Number of events 3
|
|
Infections and infestations
Infection - Pulmonary/Upper Respiratory - Upper Airway NOS
|
25.0%
4/16 • Number of events 5
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutropenia - Bronchitis
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Edema:limb
|
6.2%
1/16 • Number of events 2
|
|
Metabolism and nutrition disorders
ALT, SGOT (serum glutamic pyruvic transaminase)
|
12.5%
2/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
6.2%
1/16 • Number of events 2
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other - (PT(INR))
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Sodium - low)
|
6.2%
1/16 • Number of events 1
|
|
Psychiatric disorders
Mood alteration - anxiety
|
6.2%
1/16 • Number of events 2
|
|
Nervous system disorders
Neurology - Other - Neuralgia
|
6.2%
1/16 • Number of events 2
|
|
Nervous system disorders
Neurology - Other - Neuro-Sensory
|
6.2%
1/16 • Number of events 3
|
|
Eye disorders
Ocular/Vision - Other - Vision Problems
|
6.2%
1/16 • Number of events 1
|
|
Eye disorders
Ocular/Vision - Other - Worsening Peripheral Vision
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Pain - Gastrointestinal - Abdomen
|
12.5%
2/16 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain - Musculoskeletal - Extremity/Limb
|
12.5%
2/16 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain - Musculoskeletal - Back
|
12.5%
2/16 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain - Gastrointestinal - Joint
|
12.5%
2/16 • Number of events 2
|
|
Nervous system disorders
Pain - Neurology - Head/Headache
|
25.0%
4/16 • Number of events 4
|
|
Nervous system disorders
Pain - Other - Other
|
18.8%
3/16 • Number of events 3
|
|
Immune system disorders
Pain - Other - Splenamalgy
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Pulmonary/Upper Respiratory - Pleura
|
6.2%
1/16 • Number of events 1
|
|
Reproductive system and breast disorders
Pain - Sexual/Reproductive Function - Pelvis
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain - Musculoskeletal - Muscle
|
18.8%
3/16 • Number of events 3
|
|
Gastrointestinal disorders
Pain - Gastrointestinal - Tooth
|
12.5%
2/16 • Number of events 2
|
|
Hepatobiliary disorders
Pain - Hepatobiliary/Pancreas - gallbladder
|
6.2%
1/16 • Number of events 1
|
|
Eye disorders
Pain - Ocular - Eye
|
6.2%
1/16 • Number of events 1
|
|
Reproductive system and breast disorders
Pain - Other - Groin
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Pain - Other - Epigastric
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Pulmonary/Upper Respiratory - Throat
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
1/16 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
12.5%
2/16 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other - Asthma
|
6.2%
1/16 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
6.2%
1/16 • Number of events 1
|
|
Renal and urinary disorders
Renal/genitourinary - Other (Dysuria)
|
6.2%
1/16 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
6.2%
1/16 • Number of events 1
|
|
Reproductive system and breast disorders
Gynecomastia
|
6.2%
1/16 • Number of events 1
|
Additional Information
Lymphoma/Myeloma Disease Oriented Team
University of Wisconsin Carbone Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place