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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA016058 | U.S. NIH Grant/Contract | View source | |
| OHSU-HEM-05011-L | Other Identifier | OHSU Knight Cancer Institute | |
| OHSU-210 | Other Identifier | OHSU IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral 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 system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this 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 I/II trial is studying the side effects of giving busulfan and fludarabine together with total-body irradiation and to see how well they work in treating patients who are undergoing a donor stem cell transplant for hematologic cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE:
PROJECTED ACCRUAL: A total of 225 patients will be accrued for this study; 25 patients accrued into the Phase I and 200 patients into Phase II.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | Experimental | Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic allogeneic lymphocytes | Biological | A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species. |
| Measure | Description | Time Frame |
|---|---|---|
| Regimen-Related Toxicities | Non-hematologic toxicities and adverse experiences ≥ Grade 3 occurrences measured up to day +100 using the NCI Common Toxicity Criteria for Adverse Events v3.0 (CTCAE). Infections and GVHD will be assessed up to 5 years post transplant. The following data represents the number of regimen-related, grade 3 and 4 toxicities that occurred in each category. | 5 years post-transplant |
| Non-relapse Mortality | Percent of subjects with non-relapse mortality two years after conditioning with busulfan with fludarabine/200 cGy TBI in patients with hematologic malignancies at moderate to high risk for graft rejection and/or relapse of underlying disease. | Two years post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The percentage of overall patient survival (out of 147 participants) for Years 1, 2, 3 and 5. | Years 1, 2, 3 and 5 |
| Progression-Free Survival | The percentage of progression-free patients (out of 147 participants) at Years 1, 2, 3, and 5. Definition of Disease Progression: MM/Plasma Cell: Increasing bone pain or increase in serum/urine monoclonal protein by 25%. CLL/NHL/HD: New sites of lymphadenopathy; ≥ 25% increase in lymph node size; Blood or bone marrow involvement with clonal B-cells; Increase of ≥ 25% bone marrow involvement; ≥ 25% increase in blood involvement with clonal B-cells. AML/ALL: Any incidence of relapse (>5% blasts) by evaluation of the bone marrow aspirate. CML: Inability to control platelet or granulocyte counts; Increase in baseline number of metaphases demonstrating the Ph+ chromosome by >25%; Any other new cytogenetic abnormality; Transformation to accelerated phase or blast crisis. MDS/MPD: Any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of new blasts (>5%) or worsening cytopenia or cytogenetic evidence of recurrence. |
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DISEASE CHARACTERISTICS:
Diagnosis of a hematologic malignancy of 1 of the following high-risk types:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Maziarz, MD | OHSU Knight Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon | 97239-3098 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0 Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species. Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative. IV Busulfan is available and diluted and administered per package insert guidelines. Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| busulfan | Drug | Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative. IV busulfan is available and diluted and administered per package insert guidelines. |
|
| cyclosporine | Drug | Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including Interleukin 2 (IL-2) and Interleukin 4 (IL-4). - Starting on day -3, Cyclosporine (CSP) is given at a dose of 4.0 mg/kg p.o. b.i.d. |
|
| fludarabine phosphate | Drug | Fludarabine's active metabolite 2-fluoro-ara-A is an antimetabolite that inhibits DNA primase, DNA polymerase alpha and ribonucleotide nuclease.
|
|
| mycophenolate mofetil | Drug | Mycophenolate mofetil (MMF) is the morpholinyl ethyl ester of mycophenolic acid (MPA) and reversibly inhibits inosine monophosphate dehydrogenase, particularly the type II isoform that is more prominent in activated lymphocytes. As a result of the inhibition of de novo purine synthesis, proliferation of B- and T-lymphocytes is blocked and antibody production is inhibited.
|
|
| peripheral blood stem cell transplantation | Procedure | Bone marrow transplantation (BMT) and peripheral blood stem cell transplantation (PBSCT) are procedures that restore stem cells that have been destroyed by high doses of chemotherapy and/or radiation therapy. There are three types of transplants:
|
|
| Total Body Irradiation (TBI) | Radiation | TBI is a form of radiotherapy used primarily as part of the preparative regimen for haematopoietic stem cell (or bone marrow) transplantation. As the name implies, TBI involves irradiation of the entire body, though in modern practice the lungs are often partially shielded to lower the risk of radiation-induced lung injury.
|
|
| Granulocyte colony-stimulating factor (G-CSF) | Drug | Granulocyte colony-stimulating factor (G-CSF or GCSF) is a colony-stimulating factor hormone. G-CSF is also known as colony-stimulating factor 3 (CSF 3). It is a glycoprotein, growth factor and cytokine produced by a number of different tissues to stimulate the bone marrow to produce granulocytes and stem cells. G-CSF then stimulates the bone marrow to release them into the blood.
|
|
| Phenytoin | Drug | This drug is used to prevent seizures while on chemotherapy. |
|
| Methotrexate | Drug | Methotrexate is used to treat severe psoriasis (a skin disease in which red, scaly patches form on some areas of the body) that cannot be controlled by other treatments. |
|
| Years 1, 2, 3, and 5 |
| Relapse Mortality | The percentage of patients (out of 147 participants) who relapsed at Years 1 and 2. Relapse is defined as the presence of >5% blasts by morphology on a post-transplant bone marrow aspirate. | Years 1 and 2 |
| Acute Graft-Versus-Host Disease (aGVHD) Outcome | Grading of Acute GVHD: Severity of Individual Organ Involvement: Skin
Severity of GVHD: Grade 1 +1 to +2 skin rash; No gut or liver involvement Grade 2 +1 to +3 skin rash;+1 GI involvement and/or +1 liver | Day 100, Month 6 |
| Chronic Graft-Versus-Host Disease (cGVHD) Outcome | Grading of Chronic GVHD: Limited: Localized skin involvement and/or hepatic dysfunction due to chronic GVHD Extensive: One or more of the following: Generalized skin involvement Liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis Involvement of the eye: Schirmer's test with <5 mm wetting Involvement of minor salivary glands or oral mucosa demonstrated on labial biopsy Involvement of any other target organ Chronic GVHD Severity: Mild: Signs and symptoms of cGVHD do not interfere substantially with function and do not progress once appropriately treated with local therapy or standard systemic therapy. Moderate: Signs and symptoms of cGVHD interfere somewhat with function despite appropriate therapy or are progressive through first line systemic therapy. Severe: Signs and symptoms of cGVHD limit function substantially despite appropriate therapy or are progressive through second line systemic therapy | Years 1, 2 and 3 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0 Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species. Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative. IV Busulfan is available and diluted and administered per package insert guidelines. Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including |
| 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 |
| ||||||||||||||||||
| Karnofsky Performance Score (KPS) | KPS Scale: 100 = Normal, no complaints, no evidence of disease. 90 = Able to carry on normal activity; minor signs or symptoms of disease. 80 = Normal activity with effort; some signs or symptoms of disease. 70 = Cares for self, unable to carry on normal activity or to do active work. 60 = Requires occasional assistance, but is able to care for most of his/her needs. 50 = Requires considerable assistance and frequent medical care. 40-0 = Not eligible | Eight patients did not have KPS status available, which is why the values do not add up to the total number of participants. | Count of Participants | Participants |
| ||||||||||||||||
| Pre-Transplant Disease Status | Count of Participants | Participants |
| ||||||||||||||||||
| Disease Risk Index (DRI) | DRI was unclassifiable in 3 patients. | Count of Participants | Participants |
| |||||||||||||||||
| HLA Match | HLA Criteria: Related to the patient and genotypically or phenotypically HLA-identical (8/8). Single antigen mismatch (7/8) can be accepted if no other donor is available. OR Unrelated to the patient and HLA matched by molecular typing, allowing a single allele or antigen mismatch (7/8). | Count of Participants | Participants |
| |||||||||||||||||
| Donor Relation | Count of Participants | Participants |
| ||||||||||||||||||
| Cytomegalovirus (CMV) Status | Cytomegalovirus (CMV) status was unavailable in 7 patients. | Count of Participants | Participants |
| |||||||||||||||||
| Donor/Recipient Gender | 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 | Regimen-Related Toxicities | Non-hematologic toxicities and adverse experiences ≥ Grade 3 occurrences measured up to day +100 using the NCI Common Toxicity Criteria for Adverse Events v3.0 (CTCAE). Infections and GVHD will be assessed up to 5 years post transplant. The following data represents the number of regimen-related, grade 3 and 4 toxicities that occurred in each category. | Posted | Number | Toxicities | 5 years post-transplant |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Non-relapse Mortality | Percent of subjects with non-relapse mortality two years after conditioning with busulfan with fludarabine/200 cGy TBI in patients with hematologic malignancies at moderate to high risk for graft rejection and/or relapse of underlying disease. | Posted | Count of Participants | Participants | Two years post-transplant |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | The percentage of overall patient survival (out of 147 participants) for Years 1, 2, 3 and 5. | Posted | Number | percentage of analyzed participants | Years 1, 2, 3 and 5 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival | The percentage of progression-free patients (out of 147 participants) at Years 1, 2, 3, and 5. Definition of Disease Progression: MM/Plasma Cell: Increasing bone pain or increase in serum/urine monoclonal protein by 25%. CLL/NHL/HD: New sites of lymphadenopathy; ≥ 25% increase in lymph node size; Blood or bone marrow involvement with clonal B-cells; Increase of ≥ 25% bone marrow involvement; ≥ 25% increase in blood involvement with clonal B-cells. AML/ALL: Any incidence of relapse (>5% blasts) by evaluation of the bone marrow aspirate. CML: Inability to control platelet or granulocyte counts; Increase in baseline number of metaphases demonstrating the Ph+ chromosome by >25%; Any other new cytogenetic abnormality; Transformation to accelerated phase or blast crisis. MDS/MPD: Any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of new blasts (>5%) or worsening cytopenia or cytogenetic evidence of recurrence. | Posted | Number | percentage of analyzed participants | Years 1, 2, 3, and 5 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Relapse Mortality | The percentage of patients (out of 147 participants) who relapsed at Years 1 and 2. Relapse is defined as the presence of >5% blasts by morphology on a post-transplant bone marrow aspirate. | Posted | Number | percentage of analyzed participants | Years 1 and 2 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Acute Graft-Versus-Host Disease (aGVHD) Outcome | Grading of Acute GVHD: Severity of Individual Organ Involvement: Skin
Severity of GVHD: Grade 1 +1 to +2 skin rash; No gut or liver involvement Grade 2 +1 to +3 skin rash;+1 GI involvement and/or +1 liver | This is cumulative incidence of grades 2-4 aGVHD at 100 days and at 6 months. Out of the total number of participants, grades 2-4 aGVHD occurred in 79 patients. | Posted | Number | percentage of analyzed participants | Day 100, Month 6 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Chronic Graft-Versus-Host Disease (cGVHD) Outcome | Grading of Chronic GVHD: Limited: Localized skin involvement and/or hepatic dysfunction due to chronic GVHD Extensive: One or more of the following: Generalized skin involvement Liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis Involvement of the eye: Schirmer's test with <5 mm wetting Involvement of minor salivary glands or oral mucosa demonstrated on labial biopsy Involvement of any other target organ Chronic GVHD Severity: Mild: Signs and symptoms of cGVHD do not interfere substantially with function and do not progress once appropriately treated with local therapy or standard systemic therapy. Moderate: Signs and symptoms of cGVHD interfere somewhat with function despite appropriate therapy or are progressive through first line systemic therapy. Severe: Signs and symptoms of cGVHD limit function substantially despite appropriate therapy or are progressive through second line systemic therapy | This is a cumulative incidence of cGVHD at 1 year, 2 years, and 3 years. A total of 99 patients (out of 147) developed cGVHD, 86 patients (87%) with extensive stage cGVHD and 13 patients (13%) with limited stage cGVHD. | Posted | Number | percentage of analyzed participants | Years 1, 2 and 3 |
|
Non-hematologic toxicities and adverse experiences ≥ Grade 3 will be assessed up to day +100 using the NCI Common Toxicity Criteria for Adverse Events v3.0 (CTCAE). Infections and GVHD will be assessed up to 5 years post 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 | Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) | Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0 Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species. Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative. IV Busulfan is available and diluted and administered per package insert guidelines. Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including | 59 | 147 | 52 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left ventricular systolic dysfunction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Pericardial effusion | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Atrial fibrillation/flutter | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Left ventricular dysfunction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Respiratory pulseless electrical activity (PEA) arrest | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Event associated with CsA | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Cryptogenic organizing pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Eosinophilic pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| CsA toxicity | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Posterior-reversible encephalopathy syndrome | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Veno-occlusive disease | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Iron overload | General disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Steroid myopathy | General disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Hemolysis | General disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| ABO incompatability | General disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Bleeding | General disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Thrombosis/deep vein thrombosis | General disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Thrombotic thrombocytopenic purpura (TTP) | General disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Refractory ascites | General disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Ogilvie's syndrome | General disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Fractures/musculoskeletal | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
| Death Caused by Bacterial Infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | Unrelated to regimen |
|
| Death Caused by Fungal Infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | Unrelated to regimen |
|
| Death Caused by Sepsis/Septic Shock | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | Unrelated to regimen |
|
| Death Caused by Viral Infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | Unrelated to regimen |
|
| Death Caused by Nonspecified Pneumonia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | Unrelated to regimen |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenic fever | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Unrelated to Regimen |
|
| Hyperbilirubinemia or transaminitis | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment | Related to regimen |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard T. Maziarz, MD | Oregon Health and Science University | 503-494-6345 | maziarzr@ohsu.edu |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D011230 | Precancerous Conditions |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D001752 | Blast Crisis |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D000075363 | Immunoglobulin Light-chain Amyloidosis |
| C580364 | Pdgfra-Associated Chronic Eosinophilic Leukemia |
| D055728 | Primary Myelofibrosis |
| D015467 | Leukemia, Neutrophilic, Chronic |
| D013920 | Thrombocythemia, Essential |
| D011087 | Polycythemia Vera |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D015456 | Leukemia, Biphenotypic, Acute |
| D008998 | Monoclonal Gammopathy of Undetermined Significance |
| D000013 | Congenital Abnormalities |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D002051 | Burkitt Lymphoma |
| D006689 | Hodgkin Disease |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D007945 | Leukemia, Lymphoid |
| D007951 | Leukemia, Myeloid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001778 | Blood Coagulation Disorders |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D006942 | Hypergammaglobulinemia |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016393 | Lymphoma, B-Cell |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016399 | Lymphoma, T-Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| D002066 | Busulfan |
| D016572 | Cyclosporine |
| C042382 | fludarabine phosphate |
| D009173 | Mycophenolic Acid |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D014916 | Whole-Body Irradiation |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D010672 | Phenytoin |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| 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 |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D006827 | Hydantoins |
| D048289 | Imidazolidines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| >=65 years |
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| KPS < 90 |
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| High or Very High |
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| 7/8 |
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| All other combinations |
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| Title | Measurements |
|---|---|
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| CNS Disorders |
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| Hepatic Disorders |
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| General Disorders |
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