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Principal Investigator left institution
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The participants are being asked to take part in this clinical trial because the participant have a lymphoid or myeloid based cancer diagnosis that requires a bone marrow transplant.
Primary Objectives
To estimate the incidence of severe acute GVHD (saGVHD) using a prophylaxis regimen with no calcineurin inhibitors after day +60 post first allogeneic Human Leukocyte antigen (HLA)-matched sibling or unrelated donor HCT for hematological malignancies.
Secondary objective
Determine the cumulative incidence of relapse, NRM, chronic GVHD, and OS in study participants at one year post-transplant.
Exploratory objectives
The investigator propose to employ two preparative regimens based on the underlying hematological malignancy. For hematological malignancies of the lymphoid lineage we will use a standard preparative regimen consisting of Total Body Irradiation and cyclophosphamide (TBI/Cy), unless TBI is contraindicated. For myeloid malignancies we will use thiotepa, busulfan, and fludarabine (TBF), a preparative regimen that has been associated with a reduced risk of relapse and trend for improved survival with comparable NRM in comparison to busulfan and cyclophosphamide (BuCy), our current regimen. All HCT recipients will receive cyclosporine in combination with methotrexate and ruxolitinib as GVHD prophylaxis. Recipients of MUD HCT will receive rATG for additional immunosuppression as is standard for unrelated donor transplants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transplant Patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib | Drug | Day +40 Dosage and Route of Administration-Ruxolitinib tablets should be administered orally BID, approximately every 12 hours, continuously, Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of saGVHD Using a ProphylaxisRegimen With no Calcineurin Inhibitors After Day 100 Post First Allogeneic HLA-Matched Sibling or Unrelated Donor HCT for Hematological Malignancies. | Development of Severe Acute GVHD (saGVHD) at or before Day 100 post transplant is considered as an event. Severe acute GVHD is defined as grade II-IVGVHD. Acute graft-vs-host disease will be evaluated using the standard grading criteria. | 100 days post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Overall Survival (OS) | The one-year survival is defined by the participant who has not died within one year after post transplantation. The rate is calculated by computing the ratio between total number of one year survival patients and the total number of patients. | One-year post-transplantation. |
Not provided
Inclusion criteria
Diagnosis:
Patients must have a related or unrelated donor matched at 12 of 12 HLA alleles.
Patient must have a Karnofsky/Lansky score of 70 or higher.
Patients must be 12 years of age or older.
Patients must have a shortening fraction >26% or left ventricular ejection fraction >40%.
Patients must have bilirubin less than or equal to 2.5 mg/dL and alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal.
Patients must have creatinine clearance, or a glomerular filtration rate (GFR), greater than 70 mL/min/1.73m2.
Patients must be free of severe infection that upon determination of principal investigator precludes BMT.
Patients must have FVC >50% predicted OR, if unable to perform pulmonary function testing, must maintain pulse oximetry oxygen saturation >92% on room air.
Female patients of childbearing age must have a negative pregnancy test.
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ashok Srinivasan, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
Not provided
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
Not provided
Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Data will be made available at the time of article publication.
Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Body Irradiation (TBI)/Cyclophosphamide (Cy) | Patients with lymphoid malignancies will receive Total Body Irradiation (TBI)/Cyclophosphamide (Cy). Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries. Participants receive 8 doses TBI. Cyclophosphamide, IV. Rabbit ATG, IV. Males with lymphoid lineage leukemia will receive an additional testicular boost concurrent with TBI. Patients who receive a bone marrow product from MSD will not receive rATG. G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is >500 cells/mm3, and ANC is<500 cells/mm3 to mobilize cells. Mesna: Mesna will be given IV approximately 15 minutes prior to each dose of cyclophosphamide and approximately 3, 6, 9, and 12 hours after each dose of cyclophosphamide. GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2023 |
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|
| Mesna | Drug | Days -3 and -2 Dosage and Route of Administration-Mesna is dosed based on the cyclophosphamide dose and generally administered in fractionated doses at approximately 20% of the total cyclophosphamide dose, Intravenous. |
|
|
| Anti-thymocyte globulin (ATG) | Drug | Days -3, -2 and -1 Dosage and Route of Administration-(7 mg/kg total dose); intravenous. |
|
|
| Cyclosporine | Drug | Day -1 Dosage and Route of Administration-3 mg/kg; dose will be adjusted to maintain a steady concentration between 250-350 ng/mL or trough concentration between 175-250 ng/mL when transitioned to intermittent dosing. |
|
|
| Cyclophosphamide | Drug | Days -3 and -2 Dosage and Route of Administration-60 mg/kg for 2 consecutive days, (120 mg/kg total dose); intravenous. |
|
|
| Fludarabine | Drug | Days -4, -3 and -2 Dosage and Route of Administration-50 mg/m2 daily for 3 consecutive days (150 mg/m2 total dose) intravenous |
|
|
| Methotrexate | Drug | Days +1, +3, +6 and +11 Dosage and Route of Administration-10 mg/m2/dose, intravenous |
|
|
| Total Body Irradiation (radiation treatment) | Radiation | Days -7, -6, -5 and -4 6.2.3 Target Dose 1200 cGy total dose delivered 150 cGy per treatment fraction delivered BID over 4 days with 6 MV photons. Dose rate should be < 10 cGy/min in patients treated at extended SSD (450-500 cm) in the TBI couch and will be less than 15 cGy/min in young children and infants treated at extended SSD (200-220 cm) on the floor. Intra-fraction interval should be 6 hours. Custom posteriorly placed (PA only) partial transmission lung shields (blocks) will be used to reduce the average dose to the lung to approximately 1000 cGy total dose. An additional 400 cGy supplemental testicular radiation delivered in 2 fractions of 200 cGy delivered for males with lymphoid lineage leukemia. |
|
|
| Bone marrow infusion | Drug | Day 0 |
|
| Busulfan | Drug | Days -4, -3 and -2 Dosage and Route of Administration-3.2 mg/kg/day; intravenous. |
|
|
| Thiotepa | Drug | Days -6 and -5 Dosage and Route of Administration-(10 mg/kg total dose); intravenous |
|
|
| Cumulative Incidence of Relapse |
Bone marrow studies for disease status evaluation will be performed at 1-year post-transplant. Testing will include a research evaluation for minimal residual disease. |
| One-year post-transplantation. |
| Cumulative Incidence of Non Relapse Mortality (NRM) | Non-relapse mortality is death without evidence of disease relapse or progression. The rate is calculated by computing the ratio between total number of NRM patients and the total number of patients. | One-year post-transplantation. |
| Cumulative Incidence of Chronic GVHD | Chronic graft-vs-host disease will be evaluated using the standard grading criteria. | One-year post-transplantation. |
| FG001 | Thiotepa, Busulfan, and Fludarabine (TBF) | Patients with myeloid, bi-phenotypic, bilineage or undifferentiated leukemia will receive thiotepa, busulfan, and fludarabine (TBF). Patients will receive TBF regimen when TBI is not appropriate. Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries. Participants receive Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV. Patients who receive a bone marrow product from MSD will not receive rATG. G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is >500 cells/mm3, and ANC is<500 cells/mm3 to mobilize cells. Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan. GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG. |
| COMPLETED |
|
| NOT COMPLETED |
|
Participants meeting eligibility criteria and who completed study therapy: Allogeneic Human Leukocyte antigen (HLA)-matched sibling or unrelated donor hematopoietic cell transplant (MSD/MUD HCT) for hematological malignancies. Hematological malignancies of the lymphoid lineage will use a standard preparative regimen consisting of Total Body Irradiation and cyclophosphamide (TBI/Cy), unless TBI is contraindicated. Myeloid malignancies will use thiotepa, busulfan, and fludarabine (TBF) regimen.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Total Body Irradiation (TBI)/Cyclophosphamide (Cy) | Patients with lymphoid malignancies will receive Total Body Irradiation (TBI)/Cyclophosphamide (Cy). Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries. Participants receive 8 doses TBI. Cyclophosphamide, IV. Rabbit ATG, IV. Males with lymphoid lineage leukemia will receive an additional testicular boost concurrent with TBI. Patients who receive a bone marrow product from MSD will not receive rATG. G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is >500 cells/mm3, and ANC is<500 cells/mm3 to mobilize cells. Mesna: Mesna will be given IV approximately 15 minutes prior to each dose of cyclophosphamide and approximately 3, 6, 9, and 12 hours after each dose of cyclophosphamide. GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG. |
| BG001 | Thiotepa, Busulfan, and Fludarabine (TBF) | Patients with myeloid, bi-phenotypic, bilineage or undifferentiated leukemia will receive thiotepa, busulfan, and fludarabine (TBF). Patients will receive TBF regimen when TBI is not appropriate. Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries. Participants receive Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV. Patients who receive a bone marrow product from MSD will not receive rATG. G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is >500 cells/mm3, and ANC is<500 cells/mm3 to mobilize cells. Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan. GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Proportion of saGVHD Using a ProphylaxisRegimen With no Calcineurin Inhibitors After Day 100 Post First Allogeneic HLA-Matched Sibling or Unrelated Donor HCT for Hematological Malignancies. | Development of Severe Acute GVHD (saGVHD) at or before Day 100 post transplant is considered as an event. Severe acute GVHD is defined as grade II-IVGVHD. Acute graft-vs-host disease will be evaluated using the standard grading criteria. | None of the 3 participants had saGVHD. | Posted | Count of Participants | Participants | 100 days post transplant |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of Overall Survival (OS) | The one-year survival is defined by the participant who has not died within one year after post transplantation. The rate is calculated by computing the ratio between total number of one year survival patients and the total number of patients. | Posted | Count of Participants | Participants | One-year post-transplantation. |
| ||||||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of Relapse | Bone marrow studies for disease status evaluation will be performed at 1-year post-transplant. Testing will include a research evaluation for minimal residual disease. | Posted | Count of Participants | Participants | One-year post-transplantation. |
| ||||||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of Non Relapse Mortality (NRM) | Non-relapse mortality is death without evidence of disease relapse or progression. The rate is calculated by computing the ratio between total number of NRM patients and the total number of patients. | Posted | Count of Participants | Participants | One-year post-transplantation. |
| ||||||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of Chronic GVHD | Chronic graft-vs-host disease will be evaluated using the standard grading criteria. | Posted | Count of Participants | Participants | One-year post-transplantation. |
|
Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TBI/Cy Regimen | Patients with lymphoid malignancies will receive Total Body Irradiation (TBI)/Cyclophosphamide (Cy). Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries. Participants receive 8 doses TBI. Cyclophosphamide, IV. Rabbit ATG, IV. Males with lymphoid lineage leukemia will receive an additional testicular boost concurrent with TBI. Patients who receive a bone marrow product from MSD will not receive rATG. G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is >500 cells/mm3, and ANC is<500 cells/mm3 to mobilize cells. Mesna: Mesna will be given IV approximately 15 minutes prior to each dose of cyclophosphamide and approximately 3, 6, 9, and 12 hours after each dose of cyclophosphamide. GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG. | 1 | 2 | 2 | 2 | 2 | 2 |
| EG001 | TBF Regimen | Patients with myeloid, bi-phenotypic, bilineage or undifferentiated leukemia will receive thiotepa, busulfan, and fludarabine (TBF). Patients will receive TBF regimen when TBI is not appropriate. Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries. Participants receive Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV. Patients who receive a bone marrow product from MSD will not receive rATG. G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is >500 cells/mm3, and ANC is<500 cells/mm3 to mobilize cells. Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan. GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG. | 0 | 1 | 1 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Systematic Assessment |
| ||
| Multi-organ failure | General disorders | Systematic Assessment |
| ||
| Sinusoidal obstruction syndrome | Hepatobiliary disorders | Systematic Assessment |
| ||
| Infections and infestations - Other, specify (Disseminated Adenovirus) | Infections and infestations | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Tracheitis | Infections and infestations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Weight loss | Investigations | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders - Other, specify (Thrombotic Microangiopathy) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Enterocolitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Sinusoidal obstruction syndrome | Hepatobiliary disorders | Systematic Assessment |
| ||
| Cytomegalovirus infection reactivation | Infections and infestations | Systematic Assessment |
| ||
| Enterocolitis infectious | Infections and infestations | Systematic Assessment |
| ||
| Epstein-Barr virus infection reactivation | Infections and infestations | Systematic Assessment |
| ||
| Fungemia | Infections and infestations | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Staphylococcus | Infections and infestations | Systematic Assessment | Upper respiratory infection |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash maculo-paukar | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Thromboembolic | Vascular disorders | Systematic Assessment |
| ||
| Rhinovirus | Infections and infestations | Systematic Assessment | Upper respiratory infection |
| |
| Human parainfluenza virus | Infections and infestations | Systematic Assessment | Upper respiratory infection |
| |
| Rhino/Enterovirus | Infections and infestations | Systematic Assessment | Upper respiratory infection |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashok Srinivasan | St. Jude Children's Research Hospital | 8662785833 | referralinfo@stjude.org |
| Mar 11, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 22, 2023 | Mar 11, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C540383 | ruxolitinib |
| D015080 | Mesna |
| D000961 | Antilymphocyte Serum |
| C512542 | thymoglobulin |
| D016572 | Cyclosporine |
| D003524 | Cyclosporins |
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D008727 | Methotrexate |
| D014916 | Whole-Body Irradiation |
| D011878 | Radiotherapy |
| D002066 | Busulfan |
| D013852 | Thiotepa |
| ID | Term |
|---|---|
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| 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 |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D008698 | Mesylates |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Patients with myeloid, bi-phenotypic, bilineage or undifferentiated leukemia will receive thiotepa, busulfan, and fludarabine (TBF). Patients will receive TBF regimen when TBI is not appropriate. Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries. TBF regimen: Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV. Patients who receive a bone marrow product from MSD will not receive Rabbit ATG. G-CSF: Use of GCSF is not recommended unless patients have not engrafted on day +21. Mesna: MESNA will be given for bladder protection to patients who receive Cyclophosphamide. Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan. GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG. |
|
|
|
|
Patients with myeloid, bi-phenotypic, bilineage or undifferentiated leukemia will receive thiotepa, busulfan, and fludarabine (TBF). Patients will receive TBF regimen when TBI is not appropriate.
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
TBF regimen: Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV.
Patients who receive a bone marrow product from MSD will not receive Rabbit ATG.
G-CSF: Use of GCSF is not recommended unless patients have not engrafted on day +21.
Mesna: MESNA will be given for bladder protection to patients who receive Cyclophosphamide.
Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
|
|
|