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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01381 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can block find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells. Giving monoclonal antibodies, low doses of chemotherapy, such as fludarabine phosphate, and low dose total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells and also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine or mycophenolate mofetil after the transplant may stop this from happening
PRIMARY OBJECTIVES:
I. To assess the feasibility, safety, and potential efficacy of treating patients with B-Cell non-Hodgkin lymphoma (NHL) with 90Y-ibritumomab tiuxetan, combined with HLA-matched related or unrelated donor hematopoietic cell transplantation.
OUTLINE: Patients receive rituximab intravenously (IV) followed by, no more than 4 hours later, indium In 111 ibritumomab tiuxetan (for imaging) IV over 10 minutes on day -21. Patients undergo gamma camera imaging on day -19. Patients receive rituximab IV followed by, no more than 4 hours later, yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV over 30-60 minutes on days -7 to -5 and undergo low-dose total-body irradiation (TBI) on day 0. After TBI, patients undergo allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. Patients who undergo PBSCT from a related donor receive oral cyclosporine twice daily on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease (GVHD). These patients also receive oral mycophenolate mofetil twice daily on days 0 to 27. Patients who undergo PBSCT from an unrelated donor receive oral cyclosporine twice daily on days -3 to 100 followed by a taper over 11 weeks in the absence of GVHD. These patients also receive oral mycophenolate mofetil three times daily on days 0 to 40 followed by a taper to day 96.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (90Y ibritumomab tiuxetan, hematopoietic transplant) | Experimental | See Detailed Description |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Related Mortality (TRM) | Cumulative incidence rate of treatment related mortality with relapse as a competing risk, assessed at 30 months. | At day +100 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall and Progression-free Survival | Kaplan-Meier estimates for overall survival (OS) and progression free survival (PFS) assessed at two years. | Up to 8 years |
| Response Rates | Up to 8 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ajay Gopal | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30454872 | Derived | Puronen CE, Cassaday RD, Stevenson PA, Sandmaier BM, Flowers ME, Green DJ, Maloney DG, Storb RF, Press OW, Gopal AK. Long-Term Follow-Up of 90Y-Ibritumomab Tiuxetan, Fludarabine, and Total Body Irradiation-Based Nonmyeloablative Allogeneic Transplant Conditioning for Persistent High-Risk B Cell Lymphoma. Biol Blood Marrow Transplant. 2018 Nov;24(11):2211-2215. doi: 10.1016/j.bbmt.2018.06.033. Epub 2018 Jul 3. | |
| 21508413 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| cyclosporine | Drug | Given orally |
|
|
| fludarabine phosphate | Drug | Given IV |
|
|
| mycophenolate mofetil | Drug | Given orally |
|
|
| yttrium Y 90 ibritumomab tiuxetan | Radiation | Given IV |
|
|
| peripheral blood stem cell transplantation | Procedure | Undergo transplantation |
|
|
| allogeneic hematopoietic stem cell transplantation | Procedure | Undergo transplantation |
|
| total-body irradiation | Radiation | Undergo TBI |
|
|
| Engraftment and Hematopoietic Toxicity | 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. | At day +100 |
| Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD. | At day +84 |
| Derived |
| Gopal AK, Guthrie KA, Rajendran J, Pagel JM, Oliveira G, Maloney DG, Matesan MC, Storb RF, Press OW. (9)(0)Y-Ibritumomab tiuxetan, fludarabine, and TBI-based nonmyeloablative allogeneic transplantation conditioning for patients with persistent high-risk B-cell lymphoma. Blood. 2011 Jul 28;118(4):1132-9. doi: 10.1182/blood-2010-12-324392. Epub 2011 Apr 20. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Related Mortality (TRM) | Cumulative incidence rate of treatment related mortality with relapse as a competing risk, assessed at 30 months. | Posted | Number | 95% Confidence Interval | percent | At day +100 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Overall and Progression-free Survival | Kaplan-Meier estimates for overall survival (OS) and progression free survival (PFS) assessed at two years. | Posted | Number | 95% Confidence Interval | percent | Up to 8 years |
|
| |||||||||||||||||||||||||||
| Secondary | Response Rates | Posted | Count of Participants | Participants | Up to 8 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Engraftment and Hematopoietic Toxicity | 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. | Posted | Median | Full Range | days | At day +100 |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence and Severity of Acute Graft-versus-host Disease (GVHD) and Chronic GVHD. | Posted | Count of Participants | Participants | At day +84 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 8 | 40 | 36 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenic fever | Blood and lymphatic system disorders |
| |||
| Bone pain | General disorders |
| |||
| Renal insufficiency | Renal and urinary disorders |
| |||
| Hypotension | Vascular disorders |
| |||
| Stroke | Nervous system disorders |
| |||
| Tumor lysis syndrome | Metabolism and nutrition disorders |
| |||
| Sepsis | Infections and infestations |
| |||
| Disease progression | Blood and lymphatic system disorders |
| |||
| Atrial fibrillation | Cardiac disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Metabolism and nutrition disorders |
| |||
| Arrhythmia | Cardiac disorders |
| |||
| Infection | Infections and infestations |
| |||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Fatigue | General disorders |
| |||
| Neutropenia | Blood and lymphatic system disorders |
| |||
| Thrombocytopenia | Blood and lymphatic system disorders |
| |||
| Febrile Neutropenia | Blood and lymphatic system disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Pain | General disorders |
| |||
| Hyperglycemia | Metabolism and nutrition disorders |
| |||
| Hypertension | Vascular disorders |
| |||
| Hypotension | Vascular disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Leukopenia | Blood and lymphatic system disorders |
| |||
| Lymphopenia | Blood and lymphatic system disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
| |||
| Elevated ALT | Investigations |
| |||
| Elevated Creatinine | Investigations |
| |||
| Decreased WBC | Investigations |
| |||
| Hyponatremia | Metabolism and nutrition disorders |
| |||
| Neuropathy | Nervous system disorders |
| |||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders |
| |||
| Hypophosphatemia | Gastrointestinal disorders |
| |||
| Edema | General disorders |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Decreased hemoglobin | Investigations |
| |||
| Embolism Thrombosis/Thrombus | Vascular disorders |
| |||
| Gastritis | Gastrointestinal disorders |
| |||
| Obstruction | Gastrointestinal disorders |
| |||
| Weakness | General disorders |
| |||
| Osteopenia | Musculoskeletal and connective tissue disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ajay Gopal | Fred Hutchinson Cancer Research Center | 206-288-2037 | akgopal@fhcrc.org |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
| D008223 | Lymphoma |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D016572 | Cyclosporine |
| C042382 | fludarabine phosphate |
| D009173 | Mycophenolic Acid |
| C422802 | ibritumomab tiuxetan |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| D008919 | Investigative Techniques |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Acute GVHD: Grade 1-2 |
| |||||
| Acute GVHD: Grade 3 |
| |||||
| Chronic extensive GVHD |
|