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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00017193 | Other Identifier | JHMIRB |
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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
| Fred Hutchinson Cancer Center | OTHER |
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.
A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT)
However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Busulfan, Fludarabine, Cytoxan | Drug | Busulfan once a day for 4 days Fludarabine once a day for 4 days Bone marrow transplant Cytoxan two doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD | Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe. | 1 year |
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Inclusion Criteria:
Patients ages between 0 to and 65 years of age.
Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor.
Acute lymphocytic leukemia (ALL) in CR1 with high risk features
Acute myeloid leukemia (AML) in CR1 with high risk features defined as:
i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype [> 3 abnormalities]
Acute Leukemias in 2nd or greater remission
Refractory or Relapsed AML
AML transformed from MDS
Myelodysplastic syndrome (MDS) beyond refractory anemia
Chronic myeloid leukemia (CML)
Chronic myelomonocytic leukemia
Philadelphia-negative myeloproliferative disorder
Relapsed chemotherapy-sensitive Hodgkin's or Non-Hodgkin's lymphoma
Multiple Myeloma-Stage III
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leo Luznik, MD | Johns Hopkins University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sydney Kimmel Comprehensive Cancer center | Baltimore | Maryland | 21231 | United States | ||
| Marcos deLima, MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25267759 | Derived | Kanakry CG, O'Donnell PV, Furlong T, de Lima MJ, Wei W, Medeot M, Mielcarek M, Champlin RE, Jones RJ, Thall PF, Andersson BS, Luznik L. Multi-institutional study of post-transplantation cyclophosphamide as single-agent graft-versus-host disease prophylaxis after allogeneic bone marrow transplantation using myeloablative busulfan and fludarabine conditioning. J Clin Oncol. 2014 Nov 1;32(31):3497-505. doi: 10.1200/JCO.2013.54.0625. Epub 2014 Sep 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BuFlu Transplant | Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BuFlu Transplant | Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD | Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
Up to 100 days after bone marrow transplant.
Systematically monitored through at least Day 60.
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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 | BuFlu Transplant | Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Primary graft failure | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AST elevation grade 3-4 | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leo Luznik, MD | SKCCC | 410-502-7732 | lluznik2@jhmi.edu |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D007938 | Leukemia |
| D009190 | Myelodysplastic Syndromes |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D002066 | Busulfan |
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Houston |
| Texas |
| 77030 |
| United States |
| Paul V. O'Donnell, M.D., Ph.D. | Seattle | Washington | 98109 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 40 |
| 92 |
| 34 |
| 92 |
| Death | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| ALT elevation grade 3-4 | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| AST elevation grade 3-4 | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hyperbilirubinemia grade 3-4 | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Bowel obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase elevated grade 3-4 | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Erythroderma | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastritis and ileitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhagic cystitis | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperuricemia | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Left ventricular systolic dysfunction | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neutropenic fever | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Renal toxicity | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Subdural hematoma | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Secondary graft failure | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diffuse alveolar hemorrhage | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Idiopathic pulmonary syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| ALT elevation grade 3-4 | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Engraftment > Day 28 | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Hyperbilirubinemia grade 3-4 | Investigations | CTCAE (4.0) | Systematic Assessment |
|
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D001855 | Bone Marrow Diseases |
| D007945 | Leukemia, Lymphoid |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D009371 | Neoplasms by Site |
| D008698 |
| Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013514 | Surgical Procedures, Operative |