Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01698 | Other Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
Not provided
Not provided
Not provided
One of two different doses of thymoglobulin will allow bone marrow engraftment with minimal Graft-versus-Host Disease and allow adequate immune response to allow the transplanted stem cells to replace the tumor cells.
This randomized phase II trial studies how well giving low dose total-body irradiation (TBI) with anti-thymocyte globulin followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic malignancies. Giving reduced intensity total-body irradiation and anti-thymocyte globulin before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also 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 total-body irradiation together with antithymocyte globulin before transplant may stop this from happening.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATG 1.7 mg/kg, TBI, transplant | Experimental | (Rabbit-ATG;Thymoglobulin,Genzyme) ATG 5.1 mg/kg in three divided doses (1.7 mg/kg/d) given over three days (day -9 to -7) followed by 450 cGy TBI and tacrolimus plus MMF GVHD prophylaxis. Patients receive lower dose anti-thymocyte globulin IV on days -9 to -7. Patients undergo total-body radiation (TBI) twice daily (BID) on day -1 and once daily (QD) on day 0. Patients then undergo peripheral blood stem cells or bone marrow transplant on day 0. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: patients receive tacrolimus orally (PO) on days -2 to 90-120 with taper for 2 months, and mycophenolate mofetil (MMF) PO BID on days 0-30. |
|
| ATG 2.5 mg/kg/d, TBI, transplant | Experimental | (Rabbit-ATG;Thymoglobulin,Genzyme) ATG 7.5 mg/kg in three divided doses (2.5 mg/kg/d) given over three days (day -9 to -7) followed by 450 cGy TBI and tacrolimus plus MMF GVHD prophylaxis. Patients receive higher dose anti-thymocyte globulin intravenously (IV) on days -9 to -7. Patients undergo total-body radiation (TBI) twice daily (BID) on day -1 and once daily (QD) on day 0. Patients then undergo peripheral blood stem cells or bone marrow transplant on day 0. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: patients receive tacrolimus orally (PO) on days -2 to 90-120 with taper for 2 months, and mycophenolate mofetil (MMF) PO BID on days 0-30. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymoglobulin | Biological | Patients eligible for participation in this study will be randomized between receiving rabbit ATG for 3 days. Thymoglobulin will be administered according to VCU BMT standard of care starting day -9 and continued daily through day -7. |
| Measure | Description | Time Frame |
|---|---|---|
| The Comparison of Functional Immune Reconstitution at 6-9 Months Following Transplant as Measured by Antibody Response to Vaccination With Inactivated Hepatitis A or B Vaccine. | A positive test result will indicate immune reconstitution, while a negative test results will indicate lack of immune reconstitution. Participants not done (ND) will be counted with the negative (Neg). | Up to 9 months following transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment of Donor Hematopoietic Stem Cells, as Measured by Time in Days to Neutrophil and Platelet Count Recovery Following Allogeneic PBSCT. | Up to 52 weeks post transplant. | |
| Survival | 2-year survival rate (%) |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amir Toor, MD | Massey Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
Not provided
| Label | URL |
|---|---|
| VCU Massey Cancer Center | View source |
Not provided
Randomized to rabbit ATG (Thymoglobulin; Genzyme, Cambridge, MA), 2.5 or 1.7 mg/kg adjusted ideal body weight/day, followed by TBI to a total dose of 4.5 Gy. Methylprednisolone 2 mg/kg given pre-medication for ATG. GVHD prophylaxis was tacrolimus starting at approximately 12 weeks post transplantation.
Consecutive patients enrolled have recurrent or high-risk hematologic malignancy, adequate end-organ function and performance status. Patient required to have 7/8 or 8/8 mismatched related donor (MRD) or unrelated donor (URD), with high-resolution typing performed for HLA-A, -B, -C, and -DRB1.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | A:Thymoglobulin: 1.7 mg/kg/Day | 1.7 mg/kg/d thymoglobulin IV d-9 to -7 |
| FG001 | B:Thymoglobulin: 2.5 mg/kg/Day | 2.5 mg/kg/d thymoglobulin IV d-9 to d-7 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Total-Body Irradiation | Radiation | Undergo TBI |
|
|
| Allogeneic PBSCT or BMT | Procedure | Undergo allogeneic PBSCT or BMT |
|
|
| Tacrolimus | Drug | Given PO |
|
|
| Mycophenolate Mofetil | Drug | Given PO |
|
|
| Treatment Related Mortality | Day 100 |
| Event-free Survival | 2 years |
| Relapse | Patients with different disease relapses was determined according to current clinical standards based on the disease. For example, AML or MDS relapse is determined by a bone marrow biopsy. Multiple myeloma relapse requires a number of labs and/or biopsy to diagnose such as SPEP, UPEP, immunofixation, serum and urine light chains. In lymphoma disease is followed using CT and/or PET scans. | 2 year relapse rate (%) |
| Donor Lymphocyte Infusion | 2 year rate of DLI |
| Acute Graft-Versus-Host Disease (GVHD) | 2 year rate (%) |
| Chronic Graft-Versus-Host Disease (GVHD) | 2 year GVHD rate |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Subjects able to proceed to transplant.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | A:Thymoglobulin: 1.7 mg/kg/Day | 1.7 mg/kg/d thymoglobulin IV d-9 to -7 |
| BG001 | B:Thymoglobulin: 2.5 mg/kg/Day | 2.5 mg/kg/d thymoglobulin IV d-9 to d-7 |
| 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 | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | 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 | The Comparison of Functional Immune Reconstitution at 6-9 Months Following Transplant as Measured by Antibody Response to Vaccination With Inactivated Hepatitis A or B Vaccine. | A positive test result will indicate immune reconstitution, while a negative test results will indicate lack of immune reconstitution. Participants not done (ND) will be counted with the negative (Neg). | Posted | Number | participants | Up to 9 months following transplant |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Engraftment of Donor Hematopoietic Stem Cells, as Measured by Time in Days to Neutrophil and Platelet Count Recovery Following Allogeneic PBSCT. | Posted | Median | 95% Confidence Interval | Days | Up to 52 weeks post transplant. |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Survival | Posted | Number | percentage of patient surviving | 2-year survival rate (%) |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment Related Mortality | Posted | Number | percentage of patients | Day 100 |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Event-free Survival | Posted | Number | percentage of participants | 2 years |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Relapse | Patients with different disease relapses was determined according to current clinical standards based on the disease. For example, AML or MDS relapse is determined by a bone marrow biopsy. Multiple myeloma relapse requires a number of labs and/or biopsy to diagnose such as SPEP, UPEP, immunofixation, serum and urine light chains. In lymphoma disease is followed using CT and/or PET scans. | Posted | Number | Percent patients relapsing | 2 year relapse rate (%) |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Donor Lymphocyte Infusion | Posted | Number | percentage of participants | 2 year rate of DLI |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Acute Graft-Versus-Host Disease (GVHD) | Posted | Number | percentage of participant | 2 year rate (%) |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Chronic Graft-Versus-Host Disease (GVHD) | Posted | Number | percentage of participants | 2 year GVHD rate |
|
|
All events collected from first patient accrual up to day 180 or relapse for each subject on each arm.
Still collecting SAEs, subjects on trial until death.
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 | A:Thymoglobulin: 1.7 mg/kg/Day | 1.7 mg/kg/d thymoglobulin IV d-9 to -7 | 7 | 19 | 19 | 19 | ||
| EG001 | B:Thymoglobulin: 2.5 mg/kg/Day | 2.5 mg/kg/d thymoglobulin IV d-9 to d-7 | 12 | 22 | 22 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | CTCAE version 3 | Systematic Assessment | brain |
|
| Hepatic | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment | liver |
|
| CNS toxicity | Nervous system disorders | CTCAE version 3 | Systematic Assessment | brain |
|
| Cardiac dysrhythmia | Cardiac disorders | CTCAE version 3 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
| |
| Hemorrhagic cystitis | Renal and urinary disorders | CTCAE version 3 | Systematic Assessment |
| |
| Fever with out bacteremia | Infections and infestations | CTCAE version 3 | Systematic Assessment |
| |
| Fever with Bacteremia +/- abscess | Infections and infestations | CTCAE version 3 | Systematic Assessment |
| |
| Intra-abdominal | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
| |
| Brain abscess | Nervous system disorders | CTCAE version 3 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment | vomiting |
|
| Renal | Renal and urinary disorders | CTCAE version 3 | Systematic Assessment |
| |
| Hyponatremia | Renal and urinary disorders | CTCAE version 3 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 3 neutropenia | Blood and lymphatic system disorders | CTCAE version 3 | Systematic Assessment |
| |
| Lymphopenia post conditioning | Blood and lymphatic system disorders | CTCAE version 3 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE version 3 | Systematic Assessment |
| |
| Ocular | Eye disorders | CTCAE version 3 | Systematic Assessment |
| |
| Post transplant neutropenia | Blood and lymphatic system disorders | CTCAE version 3 | Systematic Assessment |
| |
| Bacteremia/Fever | Infections and infestations | CTCAE version 3 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE version 3 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE version 3 | Systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | CTCAE version 3 | Systematic Assessment | UTI |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amir A Toor, MD | Virginia Commonwealth University | 804-828-4360 | atoor@mcvh-vcu.edu |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D007938 | Leukemia |
| D009101 | Multiple Myeloma |
| D015470 | Leukemia, Myeloid, Acute |
| D006689 | Hodgkin Disease |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D007951 | Leukemia, Myeloid |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C512542 | thymoglobulin |
| D000961 | Antilymphocyte Serum |
| D014916 | Whole-Body Irradiation |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| 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 |
| 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 |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
|
|