NCT00119392 · STUDY IN CONTEXT
Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Cumulative incidence rate of treatment related mortality with relapse as a competing risk, assessed at 30 months.
Kaplan-Meier estimates for overall survival (OS) and progression free survival (PFS) assessed at two years.
Response Rates
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.
Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-ruxience-816f4f4a
- nct id
- NCT00119392
- trial label
- Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
- applicability
- unclear
- applicability note
- Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-ruxience-816f4f4a
- nct id
- NCT00119392
- outcome key
- om-0000
- source section id
- NCT00119392-om-0000
- source outcome index
- 0
- endpoint
- Treatment Related Mortality (TRM)
- endpoint definition
- Cumulative incidence rate of treatment related mortality with relapse as a competing risk, assessed at 30 months.
- time origin
- At day +100
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-ruxience-816f4f4a
- nct id
- NCT00119392
- outcome key
- om-0001
- source section id
- NCT00119392-om-0001
- source outcome index
- 1
- endpoint
- Overall and Progression-free Survival
- endpoint definition
- Kaplan-Meier estimates for overall survival (OS) and progression free survival (PFS) assessed at two years.
- time origin
- Up to 8 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-ruxience-816f4f4a
- nct id
- NCT00119392
- outcome key
- om-0002
- source section id
- NCT00119392-om-0002
- source outcome index
- 2
- endpoint
- Response Rates
- endpoint definition
- Response Rates
- time origin
- Up to 8 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-ruxience-816f4f4a
- nct id
- NCT00119392
- outcome key
- om-0003
- source section id
- NCT00119392-om-0003
- source outcome index
- 3
- endpoint
- Engraftment and Hematopoietic Toxicity
- endpoint definition
- 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 origin
- At day +100
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-ruxience-816f4f4a
- nct id
- NCT00119392
- outcome key
- om-0004
- source section id
- NCT00119392-om-0004
- source outcome index
- 4
- endpoint
- Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.
- endpoint definition
- Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD.
- time origin
- At day +84
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-ruxience-816f4f4a
- nct id
- NCT00119392
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
- regimen
- 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
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00119392-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-ruxience-816f4f4a
- nct id
- NCT00119392
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
- regimen
- 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
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00119392-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-ruxience-816f4f4a
- nct id
- NCT00119392
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
- regimen
- 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
- analyzed count
- 42
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00119392-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-ruxience-816f4f4a
- nct id
- NCT00119392
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
- regimen
- 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
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00119392-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-ruxience-816f4f4a
- nct id
- NCT00119392
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
- regimen
- 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
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00119392-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-non-hodgkin-lymphoma-ruxience-816f4f4a
- nct id
- NCT00119392
- harm key
- EG000
- source section id
- NCT00119392-ae
- event group key
- EG000
- event group label
- Treatment (90Y Ibritumomab Tiuxetan, Hematopoietic Transplant)
- serious affected
- 8
- serious at risk
- 40
- other affected
- 36
- other at risk
- 40
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice
Triangle