| ID | Type | Description | Link |
|---|---|---|---|
| 78998 | Other Identifier | Stanford University Alternate IRB Approval Number | |
| BMT153 | Other Identifier | OnCore |
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To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GvHD) occurs.
This study evaluated whether TLI-ATG conditioning followed by allogeneic hematpoietic cell transplant (HCT), which has provided excellent overall survival for patients with relapsed lymphoma after failed autologous HCT, provides a similar benefit in the setting of elderly patients with hematologic malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-myeloablative transplantation | Experimental | Pre-transplant total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) infusion with Day 0 allogeneic hematopoietic cell transplant (HCT), followed by post-transplant immunosuppression by cyclosporine and mycophenolate mofetil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine | Drug | Starting day -3 at a dose of 5 mg/kg orally twice daily with a target trough level of 350 to 450 ng/mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Graft vs Host Disease (GvHD) | The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages. Skin Stages
Liver Stages (Bilirubin in mg/dL)
Gastrointestinal (GI) Stages (diarrhea)
Glucksberg Overall grade
| 100 days post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Graft vs Host Disease (GvHD), All Evaluable | The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages. Skin Stages
Liver Stages (Bilirubin in mg/dL)
Gastrointestinal (GI) Stages (diarrhea)
Glucksberg Overall grade
|
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INCLUSION CRITERIA:
Any patient with one of the following hematolymphoid malignancies or syndromes in whom allogeneic hematopoietic stem cell transplant (HST) is warranted. Specific disease categories include:
Age > 50 years, or if < 50 years of age, considered to be at high risk for regimen-related toxicity associated with conventional myeloablative transplants due to pre-existing medical conditions or prior therapy.
A fully human leukocyte antigen (HLA)-identical sibling or matched unrelated donor is available. Potential participants with one antigen mismatched donors can be considered but only after discussion with the transplant team and the Principal Investigator.
Participant must be competent to give consent.
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Lowsky | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16192477 | Result | Lowsky R, Takahashi T, Liu YP, Dejbakhsh-Jones S, Grumet FC, Shizuru JA, Laport GG, Stockerl-Goldstein KE, Johnston LJ, Hoppe RT, Bloch DA, Blume KG, Negrin RS, Strober S. Protective conditioning for acute graft-versus-host disease. N Engl J Med. 2005 Sep 29;353(13):1321-31. doi: 10.1056/NEJMoa050642. | |
| 20528878 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-myeloablative Transplantation | Pre-transplant total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) infusion with Day 0 allogeneic hematopoietic cell transplant (HCT), followed by post-transplant immunosuppression by cyclosporine and mycophenolate mofetil |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Anti-thymocyte globulin (ATG) | Drug | 1.5 mg/kg for total dose of 7.5mg/kg, IV starting on day -11 to day -7 before HCT |
|
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| Mycophenolate mofetil (MMF) | Drug | Begins on day 0 after HCT at a dose of 15 mg/kg. Transplant recipients who received related donor grafts received MMF twice daily and those who received unrelated donor grafts received MMF 3 times daily. |
|
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| Filgrastim | Drug |
|
|
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| Total Lymphoid Irradiation (TLI) | Radiation | 0.8 Gy/day from day -11 to day -7 (inclusive) from day -4 to day -2 (inclusive) with 2 additional fractions of 0.8 Gy delivered on day -1 for total dose of 8 Gy. |
|
| 100 days post-transplant |
| Incidence of Relapse | Reports the overall rate of disease relapse, occurring any time within 3 years after transplant | 3 years |
| Overall Survival (OS) | 3 and 5 years |
| Event-free Survival (EFS) | Reports the number and proportion of participants who neither died due to any cause nor experienced relapse. | 3 and 5 years |
| Transplant-related Mortality | Reports the proportion of participants who expired within 1 year due to any complication or failure of the transplant. | 1 year |
| Jones CD, Arai S, Lowsky R, Tyan DB, Zehnder JL, Miklos DB. Complete donor T-cell engraftment 30 days after allogeneic transplantation predicts molecular remission in high-risk chronic lymphocytic leukaemia. Br J Haematol. 2010 Sep;150(5):637-9. doi: 10.1111/j.1365-2141.2010.08252.x. Epub 2010 Jun 7. No abstract available. |
| 26146806 | Result | Rezvani AR, Kanate AS, Efron B, Chhabra S, Kohrt HE, Shizuru JA, Laport GG, Miklos DB, Benjamin JE, Johnston LJ, Arai S, Weng WK, Negrin RS, Strober S, Lowsky R. Allogeneic hematopoietic cell transplantation after failed autologous transplant for lymphoma using TLI and anti-thymocyte globulin conditioning. Bone Marrow Transplant. 2015 Oct;50(10):1286-92. doi: 10.1038/bmt.2015.149. Epub 2015 Jul 6. |
| 19423725 | Result | Kohrt HE, Turnbull BB, Heydari K, Shizuru JA, Laport GG, Miklos DB, Johnston LJ, Arai S, Weng WK, Hoppe RT, Lavori PW, Blume KG, Negrin RS, Strober S, Lowsky R. TLI and ATG conditioning with low risk of graft-versus-host disease retains antitumor reactions after allogeneic hematopoietic cell transplantation from related and unrelated donors. Blood. 2009 Jul 30;114(5):1099-109. doi: 10.1182/blood-2009-03-211441. Epub 2009 May 7. |
| 24607552 | Result | Benjamin J, Chhabra S, Kohrt HE, Lavori P, Laport GG, Arai S, Johnston L, Miklos DB, Shizuru JA, Weng WK, Negrin RS, Lowsky R. Total lymphoid irradiation-antithymocyte globulin conditioning and allogeneic transplantation for patients with myelodysplastic syndromes and myeloproliferative neoplasms. Biol Blood Marrow Transplant. 2014 Jun;20(6):837-43. doi: 10.1016/j.bbmt.2014.02.023. Epub 2014 Mar 7. |
| Transplanted |
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| 90 Days Post-transplant |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-myeloablative Transplantation | Pre-transplant total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) infusion with Day 0 allogeneic hematopoietic cell transplant (HCT), followed by post-transplant immunosuppression by cyclosporine and mycophenolate mofetil |
| 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 |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Histology | 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 | Acute Graft vs Host Disease (GvHD) | The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages. Skin Stages
Liver Stages (Bilirubin in mg/dL)
Gastrointestinal (GI) Stages (diarrhea)
Glucksberg Overall grade
| Reports the incidence of Grades 2 to 4 acute GvHD, as observed for the initial 37 participants treated on this study, who constitute the Primary Analysis for the study. See linked citation Lowsky, et al. NEJM. 29Sep2005;353(13)1321-1331. | Posted | Number | percentage of participants | 100 days post-transplant |
|
|
| ||||||||||||||||||||||||||
| Secondary | Acute Graft vs Host Disease (GvHD), All Evaluable | The incidence of acute GvHD after transplantation was assessed per Glucksberg GvHD grade, a compound scale based on the following combinations of disease stages. Skin Stages
Liver Stages (Bilirubin in mg/dL)
Gastrointestinal (GI) Stages (diarrhea)
Glucksberg Overall grade
| Reports data for all evaluable participants | Posted | Number | percentage of participants | 100 days post-transplant |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Relapse | Reports the overall rate of disease relapse, occurring any time within 3 years after transplant | Posted | Number | percentage of participants | 3 years |
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| Secondary | Overall Survival (OS) | Posted | Number | percentage of participants | 3 and 5 years |
|
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| ||||||||||||||||||||||||||||
| Secondary | Event-free Survival (EFS) | Reports the number and proportion of participants who neither died due to any cause nor experienced relapse. | Posted | Count of Participants | Participants | 3 and 5 years |
|
| ||||||||||||||||||||||||||||
| Secondary | Transplant-related Mortality | Reports the proportion of participants who expired within 1 year due to any complication or failure of the transplant. | Posted | Number | percentage of participants | 1 year |
|
|
5 years
Adverse events other than death, secondary malignancy, or relapse were not collected.
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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 | Non-myeloablative Transplantation | 138 | 303 | 138 | 303 | 55 | 303 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deaths | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Secondary malignancy | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Secondary malignancy | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Secondary malignancy | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Secondary malignancy | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Secondary malignancy | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Lowsky | Stanford University | 650-723-0822 | rlowsky@stanford.edu |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D000961 | Antilymphocyte Serum |
| C512542 | thymoglobulin |
| D009173 | Mycophenolic Acid |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D001685 | Biological Factors |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Acute Monocytic Leukemia |
|
| Acute Myeloid Leukemia |
|
| Acute Promyelocytic Leukemia |
|
| Angioimmunoblastic T-Cell Lymphoma |
|
| B lymphoblastic leukemia/lymphoma, NOS |
|
| B-Cell Chr. Lymph. Leuk./Small Lymph. Lymphoma |
|
| Chronic Myelogenous Leukemia, Bcr/Abl Positive |
|
| Chronic Myeloid Leukemia, Nos |
|
| Chronic Myeloproliferative Disease, Nos |
|
| Cutaneous T-Cell Lymphoma, Nos |
|
| Follicular Lymphoma, Grade 1-3 |
|
| Hodgkin Lymphoma, Nodular Sclerosis, Nos |
|
| Hodgkin Lymphoma, Nos |
|
| Malignant Lymphoma, Non-Hodgkin |
|
| Mantle Cell Lymphoma |
|
| Marginal Zone B-Cell Lymphoma, Nos |
|
| Mature T-Cell Lymphoma, Nos |
|
| Ml, Large B-Cell, Diffuse |
|
| Ml, Small B Lymphocytic, Nos |
|
| Myelodysplastic Syndrome, Nos |
|
| Precursor Cell Lymphoblastic Leukemia, Nos |
|
| Prolymphocytic Leukemia, Nos |
|
| Prolymphocytic Leukemia, T-Cell Type |
|
| Subcutaneous Panniculitis-Like T-Cell Lymphoma |
|
| Unknown |
|
| Participants |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Categories |
|---|
| 3 years |
| |||||
| 5 years |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| 3 years |
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| 5 years |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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