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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-06066 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, total-body irradiation, and rituximab before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It 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 and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy together with rituximab and an umbilical cord blood transplant works in treating patients with B-cell non-Hodgkin's lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE:
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unrelated Donor Umbilical Cord Transplant | Experimental | Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological |
| ||
| rituximab |
| Measure | Description | Time Frame |
|---|---|---|
| Survival at 1 Year After Transplantation | The number of patients survival status 1 year after transplantation | 1 Year after transplant |
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
CD20+* aggressive B-cell non-Hodgkin's lymphoma (NHL), including 1 of the following:
Diffuse large cell (DLC) NHL meeting 1 of the following criteria:
Large cell transformation of indolent NHL/chronic lymphocytic leukemia (CLL) meeting the following criteria:
Mantle cell lymphoma meeting 1 of the following criteria:
CD20+* indolent NHL or CLL meeting the following criteria:
Must be in second or subsequent progression (pre-allograft cytoreduction necessary but CR/PR not required)
Indolent NHL includes, but is not limited to, any of the following:
Relapsed disease must be biopsy proven
Prior pre-allograft cytoreduction may have included 1 of the following:
Single autologous stem cell transplantation with high-dose chemotherapy conditioning, if appropriate, and no conditioning prior to transplantation
Two or more courses of intensive combination chemotherapy (e.g., rituximab, irinotecan hydrochloride, cetuximab, epirubicin hydrochloride [RICE]) as appropriate according to diagnosis and prior therapy
No mantle cell or DLC NHL with progressive disease at allograft work-up
No suitable matched related or unrelated donor available
Two umbilical cord blood (UCB) units available meeting the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Juliet Barker, MBBS | 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Unrelated Donor Umbilical Cord Transplant | Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Biological |
|
| cyclophosphamide | Drug |
|
| cyclosporine | Drug |
|
| fludarabine phosphate | Drug |
|
| mycophenolate mofetil | Drug |
|
| allogeneic hematopoietic stem cell transplantation | Procedure |
|
| umbilical cord blood transplantation | Procedure |
|
| total-body irradiation | Radiation |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Unrelated Donor Umbilical Cord Transplant | Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | 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 | Survival at 1 Year After Transplantation | The number of patients survival status 1 year after transplantation | Posted | Number | participants | 1 Year after transplant |
|
|
|
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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 | Unrelated Donor Umbilical Cord Transplant | Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood | 9 | 16 | 16 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood/Bone Marrow, other | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Death not assoc w CTCAE term- Death NOS | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Death not assoc w CTCAE term- Multi-organ failure | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| ALT, SGPT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| AST, SGOT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Bicarbonate, serum-low | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Calcium, high (hypercalcemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Magnesium, high (hypermagnesemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Potassium, high (hyperkalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Partial thromboplastin time (PTT) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Juliet Barker | Memorial Sloan Kettering Cancer Center | 212-639-3468 | barkerj@mskcc.org |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D020522 | Lymphoma, Mantle-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008228 | Lymphoma, Non-Hodgkin |
| D008224 | Lymphoma, Follicular |
| 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 |
| 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 |
|---|---|
| D000069585 | Filgrastim |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D016572 | Cyclosporine |
| C042382 | fludarabine phosphate |
| D009173 | Mycophenolic Acid |
| D036101 | Cord Blood Stem Cell Transplantation |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| 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 |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| 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 |
| 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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