Trial Outcomes & Findings for Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies (NCT NCT00048737)
NCT ID: NCT00048737
Last Updated: 2013-06-13
Results Overview
Graft failure is defined as either lack of hematologic recovery or lack of or loss of detectable donor cells.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
70 participants
Primary outcome timeframe
100 days
Results posted on
2013-06-13
Participant Flow
Recruitment Period: October 30, 2002 to September 21, 2010. All participants were recruited at The University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
90Y Zevalin in ASCT
Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.
Rituximab : 250 mg/m\^2 on day 1 and day 8
Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy
Cyclophosphamide : 750 mg/m\^2/day x 3, given on the same days as fludarabine, at 4-hour intervals
Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg
Fludarabine : 30 mg/m\^2/day x 3
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies
Baseline characteristics by cohort
| Measure |
90Y Zevalin in ASCT
n=70 Participants
Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.
Rituximab : 250 mg/m\^2 on day 1 and day 8
Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy
Cyclophosphamide : 750 mg/m\^2/day x 3, given on the same days as fludarabine, at 4-hour intervals
Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg
Fludarabine : 30 mg/m\^2/day x 3
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 daysGraft failure is defined as either lack of hematologic recovery or lack of or loss of detectable donor cells.
Outcome measures
| Measure |
90Y Zevalin in ASCT
n=70 Participants
Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.
Rituximab: 250 mg/m\^2 on day 1 and day 8
Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy
Cyclophosphamide : 750 mg/m\^2/day x 3, given on the same days as fludarabine, at 4-hour intervals
Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg
Fludarabine : 30 mg/m\^2/day x 3
|
|---|---|
|
Number of Participants With Graft Failure
|
1 participants
|
Adverse Events
90Y Zevalin in ASCT
Serious events: 7 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
90Y Zevalin in ASCT
n=70 participants at risk
Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.
Rituximab : 250 mg/m\^2 on day 1 and day 8
Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy
Cyclophosphamide : 750 mg/m\^2/day x 3, given on the same days as fludarabine, at 4-hour intervals
Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg
Fludarabine : 30 mg/m\^2/day x 3
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Cardiac disorders
Thrombosis
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.9%
2/70 • Number of events 2 • 9 Years and 1 Month
|
|
Renal and urinary disorders
Acute renal failure
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Infections and infestations
Sepsis
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Gastrointestinal disorders
C-Diff Colitis
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Infections and infestations
Viral Hepatitis B reactivation
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Skin and subcutaneous tissue disorders
secondary malignancy- Melanoma
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
General disorders
Right Inguinal hernia
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Respiratory, thoracic and mediastinal disorders
Prolonged Hospitalization, Generalized Weakness/Pneumonia
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Gastrointestinal disorders
Death due to G.I. GVHD
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Skin and subcutaneous tissue disorders
Secondary Malignancy-Early Nodular Basal Cell Carcinoma
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Gastrointestinal disorders
Death Due to Chronic Liver/G.I GVHD
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
Other adverse events
| Measure |
90Y Zevalin in ASCT
n=70 participants at risk
Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.
Rituximab : 250 mg/m\^2 on day 1 and day 8
Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy
Cyclophosphamide : 750 mg/m\^2/day x 3, given on the same days as fludarabine, at 4-hour intervals
Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg
Fludarabine : 30 mg/m\^2/day x 3
|
|---|---|
|
Nervous system disorders
Neuoropathy
|
2.9%
2/70 • Number of events 2 • 9 Years and 1 Month
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
4/70 • Number of events 4 • 9 Years and 1 Month
|
|
Gastrointestinal disorders
Nausea
|
87.1%
61/70 • Number of events 61 • 9 Years and 1 Month
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
28/70 • Number of events 28 • 9 Years and 1 Month
|
|
Gastrointestinal disorders
Mucositis
|
31.4%
22/70 • Number of events 22 • 9 Years and 1 Month
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
17.1%
12/70 • Number of events 12 • 9 Years and 1 Month
|
|
Hepatobiliary disorders
Elevated ALT
|
22.9%
16/70 • Number of events 16 • 9 Years and 1 Month
|
|
Hepatobiliary disorders
Elevated Alkaline Phosphatase
|
14.3%
10/70 • Number of events 10 • 9 Years and 1 Month
|
|
Hepatobiliary disorders
Increased Bilirubin
|
10.0%
7/70 • Number of events 7 • 9 Years and 1 Month
|
|
Hepatobiliary disorders
Increased LDH
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Infections and infestations
Infection
|
52.9%
37/70 • Number of events 88 • 9 Years and 1 Month
|
|
Cardiac disorders
Hypertension
|
14.3%
10/70 • Number of events 10 • 9 Years and 1 Month
|
|
Cardiac disorders
Edema
|
7.1%
5/70 • Number of events 5 • 9 Years and 1 Month
|
|
Cardiac disorders
Tachycardia
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Cardiac disorders
Low Ejection Fraction
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Renal and urinary disorders
Elevated Creatinine
|
12.9%
9/70 • Number of events 9 • 9 Years and 1 Month
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
14.3%
10/70 • Number of events 10 • 9 Years and 1 Month
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
4.3%
3/70 • Number of events 3 • 9 Years and 1 Month
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
2/70 • Number of events 2 • 9 Years and 1 Month
|
|
Nervous system disorders
Headache
|
17.1%
12/70 • Number of events 12 • 9 Years and 1 Month
|
|
Nervous system disorders
Dizziness
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Nervous system disorders
Altered Mood
|
4.3%
3/70 • Number of events 3 • 9 Years and 1 Month
|
|
Nervous system disorders
Insomnia
|
4.3%
3/70 • Number of events 3 • 9 Years and 1 Month
|
|
Nervous system disorders
Pain
|
7.1%
5/70 • Number of events 5 • 9 Years and 1 Month
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
7.1%
5/70 • Number of events 5 • 9 Years and 1 Month
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.3%
3/70 • Number of events 3 • 9 Years and 1 Month
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
45.7%
32/70 • Number of events 32 • 9 Years and 1 Month
|
|
Skin and subcutaneous tissue disorders
Skin Dryness
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
General disorders
Fever
|
30.0%
21/70 • Number of events 21 • 9 Years and 1 Month
|
|
General disorders
Fatigue
|
8.6%
6/70 • Number of events 6 • 9 Years and 1 Month
|
|
General disorders
Rigors
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Nervous system disorders
Altered Mood-Agitation
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Nervous system disorders
Anxiety
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Skin and subcutaneous tissue disorders
Fasciitis
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
|
Skin and subcutaneous tissue disorders
pruritus
|
1.4%
1/70 • Number of events 1 • 9 Years and 1 Month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place