Trial Outcomes & Findings for Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma (NCT NCT00453102)
NCT ID: NCT00453102
Last Updated: 2016-01-01
Results Overview
The overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
12 weeks post-therapy
Results posted on
2016-01-01
Participant Flow
Participant milestones
| Measure |
Zevalin + Rituximab
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Zevalin + Rituximab
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
Baseline characteristics by cohort
| Measure |
Zevalin + Rituximab
n=16 Participants
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Disease Stage
Stage I/II
|
3 participants
n=5 Participants
|
|
Disease Stage
Stage III/IV
|
13 participants
n=5 Participants
|
|
Extranodal disease sites
0, 1 sites
|
11 participants
n=5 Participants
|
|
Extranodal disease sites
2 or more sites
|
5 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
14 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
2 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
0 participants
n=5 Participants
|
|
Bone Marrow involvement
Yes
|
0 participants
n=5 Participants
|
|
Bone Marrow involvement
No
|
16 participants
n=5 Participants
|
|
Lactate dehydrogenase (LDH) Levels
Normal
|
14 participants
n=5 Participants
|
|
Lactate dehydrogenase (LDH) Levels
Elevated
|
2 participants
n=5 Participants
|
|
Bulky disease (cm)
5 and less cm
|
9 participants
n=5 Participants
|
|
Bulky disease (cm)
More than 5 cm
|
7 participants
n=5 Participants
|
|
International Prognostic Index (IPI) Risk Group
Low risk
|
3 participants
n=5 Participants
|
|
International Prognostic Index (IPI) Risk Group
Low/intermediate risk
|
9 participants
n=5 Participants
|
|
International Prognostic Index (IPI) Risk Group
Intermediate/high risk
|
4 participants
n=5 Participants
|
|
International Prognostic Index (IPI) Risk Group
High risk
|
0 participants
n=5 Participants
|
|
Follicular Lymphoma International Prognostic Index (FLIPI) Risk Group
Low risk
|
7 participants
n=5 Participants
|
|
Follicular Lymphoma International Prognostic Index (FLIPI) Risk Group
Intermediate risk
|
7 participants
n=5 Participants
|
|
Follicular Lymphoma International Prognostic Index (FLIPI) Risk Group
High risk
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post-therapyThe overall response rate (ORR) including complete response (CR), complete response unconfirmed (CRu), and partial response (PR) in participants receiving protocol therapy.
Outcome measures
| Measure |
Zevalin + Rituximab
n=16 Participants
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
|
|---|---|
|
Overall Rate of Response (ORR) in Participants Receiving Protocol Therapy.
|
87.5 percentage of participants
Interval 65.6 to 97.7
|
SECONDARY outcome
Timeframe: End of study.The time from the start of protocol therapy until the first documented or confirmed disease progression, or death related to study disease, whichever is earlier.
Outcome measures
| Measure |
Zevalin + Rituximab
n=16 Participants
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
|
|---|---|
|
Rate of Progression-Free Survival
|
47.6 months
Interval 4.0 to 93.3
|
SECONDARY outcome
Timeframe: 5 YearsPercentage of participants still alive without disease progression five years after the date of protocol therapy initiation.
Outcome measures
| Measure |
Zevalin + Rituximab
n=16 Participants
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
|
|---|---|
|
5-Year Rate of Progression-Free Survival (5-Year PFS)
|
40 percentage of participants
Interval 19.9 to 59.5
|
SECONDARY outcome
Timeframe: End of StudyPopulation: Median overall survival by Kaplan-Meier method for all patients was not attained.
The time from the date of initiation of study treatment until date of death from any cause for all participants.
Outcome measures
| Measure |
Zevalin + Rituximab
n=16 Participants
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
|
|---|---|
|
Overall Survival (OS) Rate
|
NA months
End of study was reached with 11 participants confirmed alive.
|
SECONDARY outcome
Timeframe: 5 YearsPercentage of participants still alive five years after the date of protocol therapy initiation.
Outcome measures
| Measure |
Zevalin + Rituximab
n=16 Participants
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
|
|---|---|
|
5 Year Rate of Overall Survival (5-Year OS)
|
71.8 percentage of participants
Interval 46.8 to 86.5
|
SECONDARY outcome
Timeframe: Up to 12 weeks post-therapyNumber of participants with treatment-related (possible, probable, or definite) grade 3 or higher non-hematologic adverse events.
Outcome measures
| Measure |
Zevalin + Rituximab
n=16 Participants
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
|
|---|---|
|
Number of Participants With Unacceptable Toxicity.
|
2 participants
|
Adverse Events
Zevalin + Rituximab
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zevalin + Rituximab
n=16 participants at risk
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection (Grade 3)
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Fatigue (Grade 3)
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain (Grade 3)
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Sepsis (Grade 5)
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
Zevalin + Rituximab
n=16 participants at risk
Ibritumomab Tiuxetan (Zevalin) + Rituximab
Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain (Grade 1-2)
|
18.8%
3/16 • Number of events 4
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
12.5%
2/16 • Number of events 6
|
|
Injury, poisoning and procedural complications
Allergic Reaction
|
18.8%
3/16 • Number of events 3
|
|
Gastrointestinal disorders
Anorexia
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Anxiety
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Back Pain
|
12.5%
2/16 • Number of events 2
|
|
Eye disorders
Blurred vision
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.2%
1/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Bruising
|
25.0%
4/16 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
3/16 • Number of events 4
|
|
Metabolism and nutrition disorders
Creatinine increased
|
12.5%
2/16 • Number of events 2
|
|
Gastrointestinal disorders
Dehydration
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Depression
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1
|
|
Eye disorders
Dry eye syndrome
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
2/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
2/16 • Number of events 5
|
|
Blood and lymphatic system disorders
Edema limbs
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Facial nerve disorder
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Fatigue
|
37.5%
6/16 • Number of events 8
|
|
Infections and infestations
Febrile neutropenia
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Fever
|
37.5%
6/16 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Headache
|
18.8%
3/16 • Number of events 4
|
|
Vascular disorders
Hematoma
|
6.2%
1/16 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin
|
56.2%
9/16 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.2%
1/16 • Number of events 2
|
|
Infections and infestations
Hepatic infection
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
43.8%
7/16 • Number of events 15
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
2/16 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Infection, Skin (cellulites)
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Infection, Upper airway NOS
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Joint Pain
|
18.8%
3/16 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytes
|
93.8%
15/16 • Number of events 61
|
|
Blood and lymphatic system disorders
Lymphopenia
|
50.0%
8/16 • Number of events 18
|
|
Metabolism and nutrition disorders
Metabolic/Lab - Other(Specify)
|
37.5%
6/16 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
18.8%
3/16 • Number of events 3
|
|
General disorders
Myalgia
|
18.8%
3/16 • Number of events 3
|
|
Blood and lymphatic system disorders
Myelodysplasia
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
25.0%
4/16 • Number of events 4
|
|
General disorders
Neuralgia
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils
|
56.2%
9/16 • Number of events 29
|
|
General disorders
Pain in extremity
|
12.5%
2/16 • Number of events 2
|
|
Cardiac disorders
Palpitations
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Petechiae
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Platelets
|
87.5%
14/16 • Number of events 29
|
|
Blood and lymphatic system disorders
PTT
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
4/16 • Number of events 4
|
|
Immune system disorders
Rhinitis
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Rigors/chills
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Sweating
|
6.2%
1/16 • Number of events 1
|
|
Vascular disorders
Thrombosis/embolism (vascular access)
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Tooth disorder
|
6.2%
1/16 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
12.5%
2/16 • Number of events 2
|
|
Infections and infestations
Upper respiratory infection
|
25.0%
4/16 • Number of events 4
|
|
Renal and urinary disorders
Urinary frequency
|
6.2%
1/16 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
3/16 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place