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Trial record 7 of 23 for:    CD20 Fred Hutchinson

Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00119392
Recruitment Status : Completed
First Posted : July 13, 2005
Results First Posted : May 24, 2017
Last Update Posted : June 29, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ajay Gopal, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions B-cell Chronic Lymphocytic Leukemia
Nodal Marginal Zone B-cell Lymphoma
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Small Lymphocytic Lymphoma
Splenic Marginal Zone Lymphoma
Waldenström Macroglobulinemia
Interventions Biological: rituximab
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Radiation: yttrium Y 90 ibritumomab tiuxetan
Procedure: peripheral blood stem cell transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Radiation: total-body irradiation
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
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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

Period Title: Overall Study
Started 45
Completed 40
Not Completed 5
Arm/Group Title Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
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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 Number of Baseline Participants 40
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[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
58
(29 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
13
  32.5%
Male
27
  67.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
40
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
40
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Treatment Related Mortality (TRM)
Hide Description Cumulative incidence rate of treatment related mortality with relapse as a competing risk, assessed at 30 months.
Time Frame At day +100
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[Not Specified]
Arm/Group Title Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
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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 Number of Participants Analyzed 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent
16
(4 to 28)
2.Secondary Outcome
Title Overall and Progression-free Survival
Hide Description Kaplan-Meier estimates for overall survival (OS) and progression free survival (PFS) assessed at two years.
Time Frame Up to 8 years
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[Not Specified]
Arm/Group Title Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
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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 Number of Participants Analyzed 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent
Overall survival
54
(37 to 68)
Progression free survival
31
(16 to 48)
3.Secondary Outcome
Title Response Rates
Hide Description [Not Specified]
Time Frame Up to 8 years
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[Not Specified]
Arm/Group Title Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
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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 Number of Participants Analyzed 42
Measure Type: Count of Participants
Unit of Measure: Participants
25
  59.5%
4.Secondary Outcome
Title Engraftment and Hematopoietic Toxicity
Hide Description Median 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.
Time Frame At day +100
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[Not Specified]
Arm/Group Title Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
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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 Number of Participants Analyzed 40
Median (Full Range)
Unit of Measure: days
Neutrophils
17
(0 to 34)
Platelets
11
(0 to 147)
5.Secondary Outcome
Title Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.
Hide Description [Not Specified]
Time Frame At day +84
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[Not Specified]
Arm/Group Title Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
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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 Number of Participants Analyzed 40
Measure Type: Count of Participants
Unit of Measure: Participants
Acute GVHD: Grade 1-2
27
  67.5%
Acute GVHD: Grade 3
4
  10.0%
Chronic extensive GVHD
5
  12.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
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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

All-Cause Mortality
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
Affected / at Risk (%)
Total   --/-- 
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Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
Affected / at Risk (%)
Total   8/40 (20.00%) 
Blood and lymphatic system disorders   
Neutropenic fever  1/40 (2.50%) 
Disease progression  1/40 (2.50%) 
Cardiac disorders   
Atrial fibrillation  1/40 (2.50%) 
General disorders   
Bone pain  2/40 (5.00%) 
Infections and infestations   
Sepsis  1/40 (2.50%) 
Metabolism and nutrition disorders   
Tumor lysis syndrome  1/40 (2.50%) 
Nervous system disorders   
Stroke  1/40 (2.50%) 
Renal and urinary disorders   
Renal insufficiency  1/40 (2.50%) 
Vascular disorders   
Hypotension  1/40 (2.50%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
Affected / at Risk (%)
Total   36/40 (90.00%) 
Blood and lymphatic system disorders   
Neutropenia  26/40 (65.00%) 
Thrombocytopenia  23/40 (57.50%) 
Febrile Neutropenia  9/40 (22.50%) 
Leukopenia  12/40 (30.00%) 
Lymphopenia  21/40 (52.50%) 
Cardiac disorders   
Arrhythmia  3/40 (7.50%) 
Gastrointestinal disorders   
Diarrhea  6/40 (15.00%) 
Nausea  5/40 (12.50%) 
Hypophosphatemia  2/40 (5.00%) 
Gastritis  2/40 (5.00%) 
Obstruction  3/40 (7.50%) 
General disorders   
Fatigue  8/40 (20.00%) 
Pain  5/40 (12.50%) 
Edema  3/40 (7.50%) 
Weakness  2/40 (5.00%) 
Infections and infestations   
Infection  27/40 (67.50%) 
Investigations   
Elevated ALT  2/40 (5.00%) 
Elevated Creatinine  2/40 (5.00%) 
Decreased WBC  5/40 (12.50%) 
Decreased hemoglobin  2/40 (5.00%) 
Metabolism and nutrition disorders   
Anorexia  9/40 (22.50%) 
Dehydration  5/40 (12.50%) 
Hyperglycemia  8/40 (20.00%) 
Hypokalemia  7/40 (17.50%) 
Hyponatremia  4/40 (10.00%) 
Musculoskeletal and connective tissue disorders   
Osteopenia  2/40 (5.00%) 
Nervous system disorders   
Neuropathy  2/40 (5.00%) 
Psychiatric disorders   
Insomnia  2/40 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonitis  3/40 (7.50%) 
Hypoxia  4/40 (10.00%) 
Dyspnea  3/40 (7.50%) 
Pleural Effusion  2/40 (5.00%) 
Skin and subcutaneous tissue disorders   
Rash  11/40 (27.50%) 
Vascular disorders   
Hypertension  9/40 (22.50%) 
Hypotension  3/40 (7.50%) 
Embolism Thrombosis/Thrombus  2/40 (5.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ajay Gopal
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-288-2037
EMail: akgopal@fhcrc.org
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Responsible Party: Ajay Gopal, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00119392     History of Changes
Other Study ID Numbers: 1726.00
NCI-2010-01381 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: July 12, 2005
First Posted: July 13, 2005
Results First Submitted: April 17, 2017
Results First Posted: May 24, 2017
Last Update Posted: June 29, 2018