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| ID | Type | Description | Link |
|---|---|---|---|
| P01CA015396 | U.S. NIH Grant/Contract | View source | |
| P30CA006973 | U.S. NIH Grant/Contract | View source | |
| NA_00034100 | Other Identifier | JHMIRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclophosphamide, mycophenolate mofetil, or tacrolimus after transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with tacrolimus and mycophenolate mofetil works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study. Patients are stratified according to age (≤ 19 years old vs > 19 years old).
After completion of study transplantation, patients are followed at 30 and 60 days, 6 months, 1 year, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone marrow transplant | Experimental | Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Busulfan | Drug | Days -7 to -4: 4 mg/kg PO daily OR 3.2 mg/kg IV daily OR 160 mg/m^2 daily (for pediatric recipients) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Develop Acute Graft-versus-host Disease (GVHD) | Percentage of participants who developed grades II-IV and grades III-IV acute GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+). | Day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Days to Engraftment | Median number of days to neutrophil and platelet engraftment. | Up to one year |
| Chimerism | Number of patients who achieved 100% donor chimerism. |
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematologic malignancies:
Acute myeloid leukemia (AML), meeting 1 of the following criteria:
MDS
Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:
ALL in CR1 with 1 of the following high-risk features:
ALL beyond CR1
Refractory ALL
Chronic myeloid leukemia beyond first chronic phase
Chronic myelomonocytic leukemia
Chronic lymphocytic leukemia
Myeloproliferative disorders
Hodgkin's or non-Hodgkin's lymphoma
Paroxysmal nocturnal hemoglobinuria with life-threatening thrombosis
Multiple myeloma
Very high-risk disease
Meets medical criteria for myeloablative BMT for the Sidney Kimmel Comprehensive Cancer Center
Bone marrow donor available, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Leo Luznik, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20124511 | Result | Luznik L, Bolanos-Meade J, Zahurak M, Chen AR, Smith BD, Brodsky R, Huff CA, Borrello I, Matsui W, Powell JD, Kasamon Y, Goodman SN, Hess A, Levitsky HI, Ambinder RF, Jones RJ, Fuchs EJ. High-dose cyclophosphamide as single-agent, short-course prophylaxis of graft-versus-host disease. Blood. 2010 Apr 22;115(16):3224-30. doi: 10.1182/blood-2009-11-251595. Epub 2010 Feb 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bone Marrow Transplant | Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Cyclophosphamide | Drug | Days -3, -2, +3, +4: 50 mg/kg IV daily |
|
|
| Day 30, Day 60 |
| Non-relapse Mortality | Percentage of participants who died for BMT-related reasons. | Day 100, 2 years |
| Relapse | Percentage of participants who developed relapse or progressive disease. | 2 years |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bone Marrow Transplant | Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis. |
| 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 |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||||
| 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 | Percentage of Participants Who Develop Acute Graft-versus-host Disease (GVHD) | Percentage of participants who developed grades II-IV and grades III-IV acute GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+). | The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. GVHD data was collected on 15 additional participants for a total of 132. GVHD data was not collected on the remaining 10 participants. | Posted | Count of Participants | Participants | Day 100 |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Days to Engraftment | Median number of days to neutrophil and platelet engraftment. | The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. Engraftment data was not collected on the remaining 25 participants. Recipients of related-donor (n=78) and unrelated-donor (n=39) transplants were reported separately. | Posted | Median | Full Range | days | Up to one year |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Chimerism | Number of patients who achieved 100% donor chimerism. | The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. Chimerism data was not collected on the remaining 25 participants. One participant died prior to Day 30 and was not analyzed for this outcome. | Posted | Count of Participants | Participants | Day 30, Day 60 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Non-relapse Mortality | Percentage of participants who died for BMT-related reasons. | The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. NRM data was not collected on the remaining 25 participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 100, 2 years |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Relapse | Percentage of participants who developed relapse or progressive disease. | The study data was analyzed early after 117 participants had been treated. This was done in order to publish the data and establish a new local standard of care at our institution. Relapse data was not collected on the remaining 25 participants. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
|
Up to one year
Adverse events were tracked systematically for 30-60 days depending on exact discharge date from the initial hospitalization.
Only the following adverse events were collected: all graft failures; deaths in the first sixty days; unexpected grade 4-5 events.
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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 | Bone Marrow Transplant | Myeloablative bone marrow transplant with a busulfan (Bu), cyclophosphamide (Cy), preparative regimen and post-transplant cyclophosphamide (PTCy) as GVHD prophylaxis | 66 | 142 | 20 | 142 | 0 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aspergillus pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Graft failure | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Graft versus host disease | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Multiorgan failure | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Veno-occlusive disease | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leo Luznik, MD | Johns Hopkins University | 4105027732 | luznile@jhmi.edu |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D009190 | Myelodysplastic Syndromes |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D000013 | Congenital Abnormalities |
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D001752 | Blast Crisis |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| C580364 | Pdgfra-Associated Chronic Eosinophilic Leukemia |
| D055728 | Primary Myelofibrosis |
| D015467 | Leukemia, Neutrophilic, Chronic |
| D006689 | Hodgkin Disease |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D012008 | Recurrence |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| 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 |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007951 | Leukemia, Myeloid |
| D007945 | Leukemia, Lymphoid |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D015448 | Leukemia, B-Cell |
| 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 |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
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| ID | Term |
|---|---|
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| 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 |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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