Trial Outcomes & Findings for Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NCT NCT00119392)
NCT ID: NCT00119392
Last Updated: 2018-06-29
Results Overview
Cumulative incidence rate of treatment related mortality with relapse as a competing risk, assessed at 30 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
At day +100
Results posted on
2018-06-29
Participant Flow
Participant milestones
| Measure |
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
n=40 Participants
See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At day +100Cumulative incidence rate of treatment related mortality with relapse as a competing risk, assessed at 30 months.
Outcome measures
| Measure |
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
n=40 Participants
See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI
|
|---|---|
|
Treatment Related Mortality (TRM)
|
16 percent
Interval 4.0 to 28.0
|
SECONDARY outcome
Timeframe: Up to 8 yearsKaplan-Meier estimates for overall survival (OS) and progression free survival (PFS) assessed at two years.
Outcome measures
| Measure |
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
n=40 Participants
See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI
|
|---|---|
|
Overall and Progression-free Survival
Overall survival
|
54 percent
Interval 37.0 to 68.0
|
|
Overall and Progression-free Survival
Progression free survival
|
31 percent
Interval 16.0 to 48.0
|
SECONDARY outcome
Timeframe: Up to 8 yearsOutcome measures
| Measure |
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
n=42 Participants
See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI
|
|---|---|
|
Response Rates
|
25 Participants
|
SECONDARY outcome
Timeframe: At day +100Median number of days after transplantation to a neutrophil count less than 500 neutrophils per microliter and a platelet count less than 50,000 platelets per microliter.
Outcome measures
| Measure |
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
n=40 Participants
See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI
|
|---|---|
|
Engraftment and Hematopoietic Toxicity
Neutrophils
|
17 days
Interval 0.0 to 34.0
|
|
Engraftment and Hematopoietic Toxicity
Platelets
|
11 days
Interval 0.0 to 147.0
|
SECONDARY outcome
Timeframe: At day +84Outcome measures
| Measure |
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
n=40 Participants
See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI
|
|---|---|
|
Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.
Acute GVHD: Grade 1-2
|
27 Participants
|
|
Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.
Acute GVHD: Grade 3
|
4 Participants
|
|
Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.
Chronic extensive GVHD
|
5 Participants
|
Adverse Events
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
Serious events: 8 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
n=40 participants at risk
See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenic fever
|
2.5%
1/40
|
|
General disorders
Bone pain
|
5.0%
2/40
|
|
Renal and urinary disorders
Renal insufficiency
|
2.5%
1/40
|
|
Vascular disorders
Hypotension
|
2.5%
1/40
|
|
Nervous system disorders
Stroke
|
2.5%
1/40
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
2.5%
1/40
|
|
Infections and infestations
Sepsis
|
2.5%
1/40
|
|
Blood and lymphatic system disorders
Disease progression
|
2.5%
1/40
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
1/40
|
Other adverse events
| Measure |
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
n=40 participants at risk
See Detailed Description
rituximab: Given IV
cyclosporine: Given orally
fludarabine phosphate: Given IV
mycophenolate mofetil: Given orally
yttrium Y 90 ibritumomab tiuxetan: Given IV
peripheral blood stem cell transplantation: Undergo transplantation
allogeneic hematopoietic stem cell transplantation: Undergo transplantation
total-body irradiation: Undergo TBI
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
22.5%
9/40
|
|
Cardiac disorders
Arrhythmia
|
7.5%
3/40
|
|
Infections and infestations
Infection
|
67.5%
27/40
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.5%
3/40
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
5/40
|
|
Gastrointestinal disorders
Diarrhea
|
15.0%
6/40
|
|
General disorders
Fatigue
|
20.0%
8/40
|
|
Blood and lymphatic system disorders
Neutropenia
|
65.0%
26/40
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
57.5%
23/40
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
22.5%
9/40
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.5%
11/40
|
|
General disorders
Pain
|
12.5%
5/40
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
8/40
|
|
Vascular disorders
Hypertension
|
22.5%
9/40
|
|
Vascular disorders
Hypotension
|
7.5%
3/40
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.5%
7/40
|
|
Blood and lymphatic system disorders
Leukopenia
|
30.0%
12/40
|
|
Blood and lymphatic system disorders
Lymphopenia
|
52.5%
21/40
|
|
Gastrointestinal disorders
Nausea
|
12.5%
5/40
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
4/40
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.5%
3/40
|
|
Investigations
Elevated ALT
|
5.0%
2/40
|
|
Investigations
Elevated Creatinine
|
5.0%
2/40
|
|
Investigations
Decreased WBC
|
12.5%
5/40
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
4/40
|
|
Nervous system disorders
Neuropathy
|
5.0%
2/40
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.0%
2/40
|
|
Gastrointestinal disorders
Hypophosphatemia
|
5.0%
2/40
|
|
General disorders
Edema
|
7.5%
3/40
|
|
Psychiatric disorders
Insomnia
|
5.0%
2/40
|
|
Investigations
Decreased hemoglobin
|
5.0%
2/40
|
|
Vascular disorders
Embolism Thrombosis/Thrombus
|
5.0%
2/40
|
|
Gastrointestinal disorders
Gastritis
|
5.0%
2/40
|
|
Gastrointestinal disorders
Obstruction
|
7.5%
3/40
|
|
General disorders
Weakness
|
5.0%
2/40
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
5.0%
2/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place