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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| P01CA018029 | U.S. NIH Grant/Contract | View source | |
| IR-6907 | Other Identifier | FHCRC IRB | |
| CDR0000644201 | Registry Identifier | NCI PDQ | |
| 0903004832 | Other Identifier | HIC Protocol Number | |
| NCI-2010-00713 | Registry Identifier | NCI / CTRP | |
| RG2810004 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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Did not reach one of the primary endpoints of decreased total acute GVHD
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Allogeneic hematopoietic stem cell transplant (HSCT) is a treatment that can cure acute leukemia and myelodysplasia. After giving the patient chemotherapy and total body irradiation to stop the growth of cancer and remove the patient's diseased bone marrow, healthy stem cells from a donor are infused into the patient to replace the patient's bone marrow and make red and white blood cells and platelets. Unfortunately HSCT is often complicated by 'graft versus host disease' (GVHD) in which the transplanted cells from a donor can make an immune response against the body's normal cells and cause tissue damage and severe symptoms. Removing a subset of the donor T cells, called 'naive T cells', before transplant may reduce the frequency and intensity of GVHD.
PURPOSE: This phase II trial will determine whether the removal of the naive T cells from donor cells can decrease the rate and severity of graft-vs-host disease while preserving specific immunity against infections in patients with acute leukemia or advanced myelodysplastic syndromes.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Myeloablative conditioning regimen: Patients undergo total body irradiation twice daily for 4 days (Days -10 to -7) Patients also receive thiotepa IV over 4 hours for 2 days (Days -6 and -5) and fludarabine phosphate IV over 30 minutes for 5 days (Days -6 to -2.)
Transplantation: Patients receive a CD34+ enriched allogeneic peripheral blood stem cell (PBSC) product followed by a CD45RA+ T-cell-depleted allogeneic PBSC product on day 0.
Graft-vs-host disease (GVHD) prophylaxis: Patients will receive Tacrolimus as per cohort 1. If the rate of grade II-IV acute GVHD in the first 35 patients is significantly reduced (compared to historical controls), subsequent patients are enrolled in cohort 2.
Patients are followed actively for at least 1 year post transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | CONDITIONING: Patients undergo total-body irradiation twice daily on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine IV over 30 minutes on days -6 to -2. TRANSPLANTATION: Patients undergo infusion of CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Cohort A: Patients receive tacrolimus IV continuously or orally twice daily beginning on day -1 and continuing until day 50 followed by standard taper in the absence of grade II-IV acute GVHD. Cohort B: Patients receive tacrolimus IV continuously or orally twice daily beginning on day -1 and continuing until day 30 followed by rapid taper in the absence of grade II-IV acute GVHD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine Phosphate | Drug | Fludarabine will be administered in a dose of 25 mg/m2/day IV over approximately 30 minutes for 5 consecutive days (day -6 to -2). The total dose of fludarabine will be 125 mg/m2. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Graft-vs-host Disease (GVHD): Grade I-IV, Including Those With no Reportable Acute GVHD | Number of participants with aGVHD and severity of aGVHD within the first 360 days post-transplant as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Acute GVHD is graded by standard criteria, and all suspected cases of acute GVHD will be confirmed histologically by biopsy of an affected organ. The severity of acute GVHD is determined by an assessment of the degree of involvement of the skin, liver, and gastrointestinal tract. Grade I is characterized as mild disease, Grade II as moderate, Grade III as severe (involvement of any organ system), and Grade IV as life-threatening. | Within 360 days of transplant |
| Number of Participants Who Did Not Engraft After Receiving a CD45RA+ T Cell Depleted PBSC Transplant | Graft failure is defined as either a failure to reach an ANC of >500/uL for 3 consecutive days by day 28 post-transplant, or an irreversible decrease in ANC <100 after an established donor graft, unless there is a reasonable explanation such as a viral infection or drug effect that may be responsible for a reversible decrease in ANC. | Up to 5 years post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant-related Mortality by Day 100 | Number of participants who died due to transplant-related issues within the first 100 days of transplant | Transplant to day 100 |
| Number of Participants Who Have Relapsed Within 5 Years of CD45RA+ T Cell Depleted PBSC Transplant |
Not provided
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Appropriate candidate for allogeneic hematopoietic stem cell transplantation (HSCT)
No CNS involvement refractory to intrathecal chemotherapy and/or standard cranial-spinal radiotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
DONOR CHARACTERISTICS:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Bleakley, MD | Fred Hutchinson Cancer Center | Principal Investigator |
| Warren Shlomchik, MD | Yale University School of Medicine/Yale New Haven Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine/Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35007144 | Derived | Bleakley M, Sehgal A, Seropian S, Biernacki MA, Krakow EF, Dahlberg A, Persinger H, Hilzinger B, Martin PJ, Carpenter PA, Flowers ME, Voutsinas J, Gooley TA, Loeb K, Wood BL, Heimfeld S, Riddell SR, Shlomchik WD. Naive T-Cell Depletion to Prevent Chronic Graft-Versus-Host Disease. J Clin Oncol. 2022 Apr 10;40(11):1174-1185. doi: 10.1200/JCO.21.01755. Epub 2022 Jan 10. | |
| 26053664 | Derived | Bleakley M, Heimfeld S, Loeb KR, Jones LA, Chaney C, Seropian S, Gooley TA, Sommermeyer F, Riddell SR, Shlomchik WD. Outcomes of acute leukemia patients transplanted with naive T cell-depleted stem cell grafts. J Clin Invest. 2015 Jul 1;125(7):2677-89. doi: 10.1172/JCI81229. Epub 2015 Jun 8. |
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Participants were recruited based on physician referral at 2 academic medical centers between Dec 2009 and Oct 2014. The first patient was enrolled on December 17, 2009 and the last participant was enrolled in October 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study Participants | CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| D0 to D100 Post-transplant |
|
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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 | Nov 28, 2018 |
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|
| Tacrolimus | Drug | Tacrolimus will be administered beginning on day -1 at a dose of 0.03 mg/kg/day by continuous IV infusion. For the first cohort of 35 patients, if there is no evidence of grade II-IV acute GVHD on or prior to day 50, tacrolimus should then be tapered at the rate of approximately 5% of the day 50 dose each week for liquid, and 20% of the day 50 dose per month for capsules. In the second cohort of 25 patients if there is no evidence of grade II GVHD on or prior to day 30, tacrolimus should then be tapered at the rate of approximately 8% of the day 30 dose each week for liquid, and 33% of the day 30 dose per month for capsules. |
|
|
| Thiotepa | Drug | Thiotepa will be administered in a dose of 5 mg/kg/day (adjusted body weight) IV over approximately 4 hours for 2 consecutive days (day -6 and day -5). |
|
|
| Total-Body Irradiation (TBI) | Radiation | TBI will be given as 165 cGy fractions twice per day x 4 days - total dose 1320cGy (days -10 to -7). |
|
|
| Magnetic Affinity Cell Sorting | Other | Device |
|
|
| Peripheral Blood Stem Cell Transplantation | Procedure | Patient will undergo a PBSC transplantation |
|
|
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | Patients who are considered appropriate candidates for allogeneic hematopoietic stem cell transplantation |
|
| T Cell-Depleted Hematopoietic Stem Cell Transplantation | Biological | Patients who are eligible will receive a T Cell-Depleted Hematopoietic Stem Cell Transplantation |
|
Relapse is defined by the presence of malignant cells in marrow, peripheral blood, or extramedullary sites by histopathology. Testing for recurrent malignancy in the blood and bone marrow performed by monitoring the CBC and bone marrow at Day 28, 58, 80, 360, and as needed for suspected relapse. |
| Up to 5 years post transplant |
| Number of Participants With Chronic GVHD | Chronic GVHD measured by meeting NIH criteria and treated with immune suppression | Up to 5 years post transplant |
| Fred Hutchinson Cancer Research Center |
| Seattle |
| Washington |
| 98109-1024 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| D101 to 2 Years Post-transplant |
|
|
| 2 Years to 5 Years Post-transplant |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Participants | CONDITIONING: Patients receive TBI twice per day on days -10 to -7, then thiotepa IV administered over approximately 4 hours on days -6 and -5, and fludarabine IV administered over 30 minutes on days -6 to -2. DONOR BONE MARROW TRANSPLANTATION: GCSF-mobilized CD34 enriched PBSC and CD45RA depleted cells infused on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Ptients receive tacrolimus beginning on day -1 by continuous IV infusion, converting to oral formulation when oral feeding is established. If there is no evidence of grade II-IV acute GVHD prior to day 50, tacrolimus is then tapered. |
| 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 | Mean | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Number of Participants With Acute Graft-vs-host Disease (GVHD): Grade I-IV, Including Those With no Reportable Acute GVHD | Number of participants with aGVHD and severity of aGVHD within the first 360 days post-transplant as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Acute GVHD is graded by standard criteria, and all suspected cases of acute GVHD will be confirmed histologically by biopsy of an affected organ. The severity of acute GVHD is determined by an assessment of the degree of involvement of the skin, liver, and gastrointestinal tract. Grade I is characterized as mild disease, Grade II as moderate, Grade III as severe (involvement of any organ system), and Grade IV as life-threatening. | Posted | Count of Participants | Participants | Within 360 days of transplant |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Did Not Engraft After Receiving a CD45RA+ T Cell Depleted PBSC Transplant | Graft failure is defined as either a failure to reach an ANC of >500/uL for 3 consecutive days by day 28 post-transplant, or an irreversible decrease in ANC <100 after an established donor graft, unless there is a reasonable explanation such as a viral infection or drug effect that may be responsible for a reversible decrease in ANC. | Posted | Count of Participants | Participants | Up to 5 years post transplant |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Transplant-related Mortality by Day 100 | Number of participants who died due to transplant-related issues within the first 100 days of transplant | Posted | Count of Participants | Participants | Transplant to day 100 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Have Relapsed Within 5 Years of CD45RA+ T Cell Depleted PBSC Transplant | Relapse is defined by the presence of malignant cells in marrow, peripheral blood, or extramedullary sites by histopathology. Testing for recurrent malignancy in the blood and bone marrow performed by monitoring the CBC and bone marrow at Day 28, 58, 80, 360, and as needed for suspected relapse. | Posted | Count of Participants | Participants | Up to 5 years post transplant |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Chronic GVHD | Chronic GVHD measured by meeting NIH criteria and treated with immune suppression | Participants alive and without relapse at D100 | Posted | Count of Participants | Participants | Up to 5 years post transplant |
|
|
AEs and SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 5 year
No Serious Adverse Events reported were related to the investigational cell product, but to the transplant or other indications.
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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 | Overall Study Participants | CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis | 13 | 41 | 39 | 41 | 41 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Acute Kidney Injury | Renal and urinary disorders | CTCAE v.4 | Systematic Assessment | Grades 2-4 |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Bladder infection | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE v.4 | Systematic Assessment | Grade 4 |
|
| Catheter related infection | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Colitis | Gastrointestinal disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Diarrhea | Gastrointestinal disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Duodenal infection | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Enterocolitis | Gastrointestinal disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Esophageal hemorrhage | Gastrointestinal disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Generalized muslce weakness | Musculoskeletal and connective tissue disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Headache | Nervous system disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Hypotension | Vascular disorders | CTCAE v.4 | Systematic Assessment | Grades 3-4 |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE v.4 | Systematic Assessment | Grades 3-4 |
|
| Coagulase-negative staph bacteremia | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Clostridium difficile infection | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| CMV reactivation | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| E Coli Bacteremia | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Leptotrichia buccalis infection | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| MRSA bacteremia | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Candida Glabrata | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Enterococcus faecium | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Strep mitis | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Strep Viridans | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| VRE bacteremia | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Laryngeal edema | Respiratory, thoracic and mediastinal disorders | CTCAE v.4 | Systematic Assessment | Grade 4 |
|
| Lung infection | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Mucositis, oral | Gastrointestinal disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Nausea | Gastrointestinal disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE v.4 | Systematic Assessment | bilateral LE leg pain requiring PCA - Grade 3 |
|
| Palmar-plantar erythrodysesthesia | Skin and subcutaneous tissue disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Pericardial effusion | Cardiac disorders | CTCAE v.4 | Systematic Assessment | Grade 4 |
|
| Pericarditis | Cardiac disorders | CTCAE v.4 | Systematic Assessment | Grade 4 |
|
| Rectal pain | Gastrointestinal disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE v.4 | Systematic Assessment | Grade 5 |
|
| Aspiration Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE v.4 | Systematic Assessment | Grade 4 |
|
| Sepsis | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 4 |
|
| Sinusitis | Infections and infestations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Neutrophil count decreased | Investigations | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v.4 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE v.4 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE v.4 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE v.4 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE v.4 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE v.4 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE v.4 | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE v.4 | Systematic Assessment |
| |
| CD4 lymphocytes decreased | Investigations | CTCAE v.4 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE v.4 | Systematic Assessment |
| |
| Hypertenstion | Vascular disorders | CTCAE v.4 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE v.4 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE v.4 | Systematic Assessment | Grade 3 |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marie Bleakley, MD | Fred Hutchinson Cancer Research Center | 206-667-6572 | mbleakle@fredhutch.org |
| Jun 10, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D007938 | Leukemia |
| D009190 | Myelodysplastic Syndromes |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D000013 | Congenital Abnormalities |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007951 | Leukemia, Myeloid |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
Not provided
Not provided
| ID | Term |
|---|---|
| C042382 | fludarabine phosphate |
| D016559 | Tacrolimus |
| D013852 | Thiotepa |
| D014916 | Whole-Body Irradiation |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Grade III acute GVHD |
|
| Grade IV acute GVHD |
|
| Steroid refractory acute GVHD |
|
|
| Title | Denominators | Categories |
|---|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Chronic GVHD that meets NIH criteria |
| |||||
| No documented chronic GVHD |
|