Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BMT330 | Other Identifier | OnCore ID | |
| IRB-47407 | Other Identifier | Stanford IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate whether addition of a low dose of total body irradiation (TBI) to a standard preparation for transplant [total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG)] conditioning will help to augment donor chimerism without reducing tolerability of this regimen or increasing the risk of graft-vs-host disease (GVHD)
Primary Objective:
• Determine the proportion of patients with full donor T-cell chimerism at Day 28 following hematopoietic cell transplantation.
Secondary Objectives:
Exploratory Objectives:
• Determine the changes in frequency of hematopoietic stem, progenitor, and mature cell subsets and the changes in cytokine milieu and cellular architecture in the bone marrow of patients receiving TLI compared to TLI+TBI.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TBI+TLI | Experimental | TBI, single exposure on Day -1, 80 centigray (cGy) in addition to total lymphoid irradiation (TLI, 120 cGy/day for 9 days, weekends excluded) and anti-thymocyte globulin (ATG) 1.5 mg/kg (conditioning regimen) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total body irradiation (TBI) | Radiation | Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Full-dose Donor Chimerism (FDC) at Day 28 Following TLI/ATG/TBI Conditioning. | Subsequent to TLI/ATG/TBI conditioning, the proportion of participants with full dose donor chimerism (FDC) will be determined by Day 28. FDC is defined as achieving ≥ 95% donor type in the CD3+ lineage within 28 days of donor cell infusion, as assessed by short tandem repeat (STR) testing. The outcome will be expressed as the number of participants that achieve FDC by Day 28, a number without dispersion. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Progression | Transplant recipients will be assessed for disease progression at 1 year after hematopoietic cell transplantation (HCT). The outcome is reported as the number of transplant recipients who experienced disease progression. | 1 year |
| Overall Survival (OS) |
Not provided
INCLUSION CRITERIA
EXCLUSION CRITERIA
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Lowsky, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TBI+TLI | TBI, single exposure on Day -1, 80 centigray (cGy) in addition to total lymphoid irradiation (TLI, 120 cGy/day for 9 days, weekends excluded) and anti-thymocyte globulin (ATG) 1.5 mg/kg (conditioning regimen) Total body irradiation (TBI): Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning Anti-thymocyte globulin (ATG): Given intravenous (IV), Dose 1.5 mg/kg x 5 days Tacrolimus: Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV) Mycophenolate mofetil (MMF): Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors. Total lymphoid irradiation (TLI): 9 x 120 cGy over 11 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Aug 10, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Anti-thymocyte globulin (ATG) | Drug | Given intravenous (IV), Dose 1.5 mg/kg x 5 days |
|
| Tacrolimus | Drug | Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV) |
|
|
| Mycophenolate mofetil (MMF) | Drug | Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors. |
|
|
| Total lymphoid irradiation (TLI) | Radiation | 9 x 120 cGy over 11 days |
|
Overall survival (OS) is defined as the number of transplant recipients remaining alive at 12 months after transplant. The outcome is expressed as the number of transplant recipients who remained alive at 12 months after treatment, a number without dispersion. |
| 1 year |
| Event-free Survival (EFS) at 1 Year | Event-free survival (EFS) is defined as the number of transplant recipients remaining alive at 12 months after transplant and who did not experience disease relapse defined as blasts < 5%. The outcome is expressed as the number of transplant recipients remaining alive at 12 months after transplant without disease relapse, a number without dispersion. | 1 year |
| Non-relapse Mortality (NRM) | Non-relapse mortality (NRM) is defined as death without known disease relapse or recurrence. The outcome is expressed as the number of transplant recipients whose cause of death was not disease relapse or recurrence, a number without dispersion. | 1 year |
| Graft vs Host Disease (GvHD) | Recipients will be monitored for Grade 2 to 4 graft vs host disease (GvHD). The outcome is reported as the number of transplant recipients who experienced acute GvHD grades 2 to 4, the number of transplant recipients who experienced chronic and extensive GvHD. In addition, the number of transplant recipients with chronic and extensive GvHD that was refractory to treatment ("persistent") is reported. Per protocol, the result for chronic extensive and persistent GvHD is based on the subset of participants that had chronic and extensive GvHD. | 1 year |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TBI+TLI | TBI, single exposure on Day -1, 80 centigray (cGy) in addition to total lymphoid irradiation (TLI, 120 cGy/day for 9 days, weekends excluded) and anti-thymocyte globulin (ATG) 1.5 mg/kg (conditioning regimen) Total body irradiation (TBI): Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning Anti-thymocyte globulin (ATG): Given intravenous (IV), Dose 1.5 mg/kg x 5 days Tacrolimus: Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV) Mycophenolate mofetil (MMF): Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors. Total lymphoid irradiation (TLI): 9 x 120 cGy over 11 days |
| 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 | Standard Deviation | 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 | Full-dose Donor Chimerism (FDC) at Day 28 Following TLI/ATG/TBI Conditioning. | Subsequent to TLI/ATG/TBI conditioning, the proportion of participants with full dose donor chimerism (FDC) will be determined by Day 28. FDC is defined as achieving ≥ 95% donor type in the CD3+ lineage within 28 days of donor cell infusion, as assessed by short tandem repeat (STR) testing. The outcome will be expressed as the number of participants that achieve FDC by Day 28, a number without dispersion. | Posted | Count of Participants | Participants | Day 28 |
|
|
| |||||||||||||||||||||||||||
| Secondary | Disease Progression | Transplant recipients will be assessed for disease progression at 1 year after hematopoietic cell transplantation (HCT). The outcome is reported as the number of transplant recipients who experienced disease progression. | Posted | Count of Participants | Participants | 1 year |
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival (OS) is defined as the number of transplant recipients remaining alive at 12 months after transplant. The outcome is expressed as the number of transplant recipients who remained alive at 12 months after treatment, a number without dispersion. | Posted | Count of Participants | Participants | 1 year |
|
| ||||||||||||||||||||||||||||
| Secondary | Event-free Survival (EFS) at 1 Year | Event-free survival (EFS) is defined as the number of transplant recipients remaining alive at 12 months after transplant and who did not experience disease relapse defined as blasts < 5%. The outcome is expressed as the number of transplant recipients remaining alive at 12 months after transplant without disease relapse, a number without dispersion. | Posted | Count of Participants | Participants | 1 year |
|
| ||||||||||||||||||||||||||||
| Secondary | Non-relapse Mortality (NRM) | Non-relapse mortality (NRM) is defined as death without known disease relapse or recurrence. The outcome is expressed as the number of transplant recipients whose cause of death was not disease relapse or recurrence, a number without dispersion. | Posted | Count of Participants | Participants | 1 year |
|
| ||||||||||||||||||||||||||||
| Secondary | Graft vs Host Disease (GvHD) | Recipients will be monitored for Grade 2 to 4 graft vs host disease (GvHD). The outcome is reported as the number of transplant recipients who experienced acute GvHD grades 2 to 4, the number of transplant recipients who experienced chronic and extensive GvHD. In addition, the number of transplant recipients with chronic and extensive GvHD that was refractory to treatment ("persistent") is reported. Per protocol, the result for chronic extensive and persistent GvHD is based on the subset of participants that had chronic and extensive GvHD. | Per protocol, the outcome for chronic extensive and persistent GvHD is based on the subset of participants that had chronic and extensive GvHD. | Posted | Count of Participants | Participants | 1 year |
|
60 days, except collection of mortality information was open-ended.
Per protocol, adverse event collection was limited, as follows.
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+TLI | TBI, single exposure on Day -1, 80 centigray (cGy) in addition to total lymphoid irradiation (TLI, 120 cGy/day for 9 days, weekends excluded) and anti-thymocyte globulin (ATG) 1.5 mg/kg (conditioning regimen) Total body irradiation (TBI): Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning Anti-thymocyte globulin (ATG): Given intravenous (IV), Dose 1.5 mg/kg x 5 days Tacrolimus: Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV) Mycophenolate mofetil (MMF): Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors. Total lymphoid irradiation (TLI): 9 x 120 cGy over 11 days | 6 | 22 | 2 | 22 | 0 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Chronic graft vs host disease | Immune system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Lowsky, Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) | Stanford University | 650-723-0822 | rlowsky@stanford.edu |
| May 13, 2021 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| D009196 | Myeloproliferative Disorders |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D016393 | Lymphoma, B-Cell |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014916 | Whole-Body Irradiation |
| D000961 | Antilymphocyte Serum |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| 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 |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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 |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|