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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-06150 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as rituximab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal 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 rituximab before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects and how well giving chemotherapy and radiation therapy together with rituximab and donor stem cell transplant works in treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Other | This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-thymocyte globulin | Biological |
| ||
| filgrastim |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival at 1 Year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Neutrophil Engraftment | 2 years | |
| Time to Platelet Engraftment | 1 year | |
| Incidence of Moderate to Severe Grades II to IV Graft Versus Host Disease (GVHD) at 100 Days |
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
CD20-positive aggressive B-cell non-Hodgkin's lymphoma (NHL), including any of the following subtypes:
Diffuse large cell lymphoma*, meeting 1 of the following criteria:
Large cell transformation of indolent NHL or chronic lymphocytic leukemia (CLL), meeting the following criteria:
Mantle cell lymphoma*, meeting 1 of the following criteria:
CD20-positive indolent NHL (e.g., follicular lymphoma, small cell lymphoma, or marginal zone NHL) OR CLL
Relapsed disease must be biopsy-proven
Must have received pre-allograft salvage chemotherapy, including 1 of the following:
HLA-compatible related or unrelated donor available
HLA-matched ≥ 9/10 of the A, B, C, DRB1, and DQB1 loci, as tested by high resolution typing
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Hugo R. Castro-Malaspina, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Juliet Barker, MBBS | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Craig Moskowitz, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24534109 | Derived | Sauter CS, Lechner L, Scordo M, Zheng J, Devlin SM, Fleming SE, Castro-Malaspina H, Moskowitz CH. Pretransplantation fluorine-18-deoxyglucose--positron emission tomography scan lacks prognostic value in chemosensitive B cell non-hodgkin lymphoma patients undergoing nonmyeloablative allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2014 Jun;20(6):881-4. doi: 10.1016/j.bbmt.2014.02.009. Epub 2014 Feb 15. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Protocol Open to Accrual 11/28/2006 Protocol Closed to Accrual 4/22/2014 Primary Completion Date 10/28/2016 Recruitment Location is the medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| graft-versus-tumor induction therapy | Biological |
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| rituximab | Biological |
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| cyclophosphamide | Drug |
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| cyclosporine | Drug |
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| fludarabine phosphate | Drug |
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| mycophenolate mofetil | Drug |
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| nonmyeloablative allogeneic hematopoietic stem cell transplantation | Procedure |
|
| total-body irradiation | Radiation |
|
| 100 days |
| Incidence of Chronic GVHD at 1 Year | 1 year |
| Immune Reconstruction/CD4+ Count at 3 Months | 3 months |
| Response to Treatment | 2 years |
| Immune Reconstruction/CD4+ Count at 6 Months | 6 months |
| Immune Reconstruction/CD4+ Count at 1 Year | 1 year |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL). |
| 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 | No |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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 | Overall Survival at 1 Year | Data for the remaining 10 patients was not fully collected or analyzed for publication | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
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| ||||||||||||||||||||||||||
| Secondary | Time to Neutrophil Engraftment | Data for the remaining 10 patients was not fully collected or analyzed for publication | Posted | Median | Full Range | days | 2 years |
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| |||||||||||||||||||||||||||
| Secondary | Time to Platelet Engraftment | Data for the remaining 10 patients was not fully collected or analyzed for publication | Posted | Median | Full Range | days | 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Moderate to Severe Grades II to IV Graft Versus Host Disease (GVHD) at 100 Days | Data for the remaining 10 patients was not fully collected or analyzed for publication | Posted | Number | 95% Confidence Interval | percentage of patients | 100 days |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Chronic GVHD at 1 Year | Data for the remaining 10 patients was not fully collected or analyzed for publication | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Immune Reconstruction/CD4+ Count at 3 Months | Data for the remaining 10 patients was not fully collected or analyzed for publication | Posted | Median | Inter-Quartile Range | cells/microliters | 3 months |
|
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| Secondary | Response to Treatment | Data for the remaining 10 patients was not fully collected or analyzed for publication | Posted | Count of Participants | Participants | 2 years |
|
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| Secondary | Immune Reconstruction/CD4+ Count at 6 Months | Data for the remaining 10 patients was not fully collected or analyzed for publication | Posted | Median | Inter-Quartile Range | cells/microliter | 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Immune Reconstruction/CD4+ Count at 1 Year | Data for the remaining 10 patients was not fully collected or analyzed for publication | Posted | Median | Inter-Quartile Range | cells/microliter | 1 year |
|
|
2 years
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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 | This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL). | 9 | 61 | 26 | 61 | 59 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperbilirubinemia | Investigations | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Confusion | Psychiatric disorders | Systematic Assessment |
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| Death Not Otherwise Specified | General disorders | Systematic Assessment |
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| Death not assoc w CTCAE term - Disease progression | General disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | Systematic Assessment |
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| Gait disturbance | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Fever (in the absence of neutropenia) | General disorders | Systematic Assessment |
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| Gastrointestinal, other | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Infection - catheter related | Infections and infestations | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Infection, other | Infections and infestations | Systematic Assessment |
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| Mucositis - oral | Gastrointestinal disorders | Systematic Assessment |
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| Neurology - other | Nervous system disorders | Systematic Assessment |
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| Sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Ocular/visual - other | Eye disorders | Systematic Assessment |
| ||
| Ophthalmoplegia/Diplopia (double vision) | Eye disorders | Systematic Assessment |
| ||
| Lymphocytopenia | Investigations | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Pain - oral cavity | Gastrointestinal disorders | Systematic Assessment |
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| Phlebitis | Vascular disorders | Systematic Assessment |
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| Rash/desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Restrictive cardiomyopathy | Cardiac disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection, other | Infections and infestations | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Creatinine | Investigations | Systematic Assessment |
| ||
| Alanine Aminotransferase | Investigations | Systematic Assessment |
| ||
| Aspartate Aminotransferase | Investigations | Systematic Assessment |
| ||
| Bilirubin | Investigations | Systematic Assessment |
| ||
| Alkaline phosphatase | Investigations | Systematic Assessment |
| ||
| Hypermagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hugo Castro-Malaspina, MD | Memorial Sloan Kettering Cancer Center | 212-639-8197 | castro-h@mskcc.org |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D020522 | Lymphoma, Mantle-Cell |
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| ID | Term |
|---|---|
| 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 |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| D000069585 | Filgrastim |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D016572 | Cyclosporine |
| C042382 | fludarabine phosphate |
| D009173 | Mycophenolic Acid |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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