A Phase 2 interventional study of Thymoglobulin and Total-Body Irradiation in Non-Hodgkin's Lymphoma, Leukemia and Multiple Myeloma, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-11-09.
Sponsored by Virginia Commonwealth University · Phase 2, Interventional, and Treatment
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.
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Exclusion Criteria:
(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.
Biological: Thymoglobulin · Radiation: Total-Body Irradiation · Procedure: Allogeneic PBSCT or BMT · Drug: Tacrolimus · Drug: Mycophenolate Mofetil
(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.
Biological: Thymoglobulin · Radiation: Total-Body Irradiation · Procedure: Allogeneic PBSCT or BMT · Drug: Tacrolimus · Drug: Mycophenolate Mofetil
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.
Also known as: anti-thymocyte globulin (rabbit), ATG, Genzyme, anti-thymocyte globulin, Rabbit, Rabbit-ATG
Undergo TBI
Also known as: Whole-Body Irradiation, Total Body Irradiation [TBI]
Undergo allogeneic PBSCT or BMT
Also known as: PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Blood Stem Cell Transplantation [Allogenic PBSCT], Allogeneic Bone Marrow Transplantation [BMT], Allogeneic BMT, Allogeneic Hematopoietic Stem Cell Transplantation, HSCT
Given PO
Also known as: Fujimycin, Hecoria, Prograf, Protopic
Given PO
Also known as: CellCept, MMF
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).
Time frame: Up to 9 months following transplant
Engraftment of Donor Hematopoietic Stem Cells, as Measured by Time in Days to Neutrophil and Platelet Count Recovery Following Allogeneic PBSCT.
Time frame: Up to 52 weeks post transplant.
Survival
Time frame: 2-year survival rate (%)
Treatment Related Mortality
Time frame: Day 100
Event-free Survival
Time frame: 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.
Time frame: 2 year relapse rate (%)
Donor Lymphocyte Infusion
Time frame: 2 year rate of DLI
Acute Graft-Versus-Host Disease (GVHD)
Time frame: 2 year rate (%)
Chronic Graft-Versus-Host Disease (GVHD)
Time frame: 2 year GVHD rate
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.
| Milestone | A:Thymoglobulin: 1.7 mg/kg/Day | B:Thymoglobulin: 2.5 mg/kg/Day |
|---|---|---|
| Started | 19 | 23 |
| Completed | 19 | 22 |
| Not completed | 0 | 1 |
| Withdrew: Unable to proceed to transplant | 0 | 1 |
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).
| participants | A:Thymoglobulin: 1.7 mg/kg/Day | B:Thymoglobulin: 2.5 mg/kg/Day |
|---|---|---|
| Positive | 8 | 3 |
| Negative/Not Done | 11 | 19 |
| Days | A:Thymoglobulin: 1.7 mg/kg/Day | B:Thymoglobulin: 2.5 mg/kg/Day |
|---|---|---|
| Engraftment of Donor Hematopoietic Stem Cells, as Measured by Time in Days to Neutrophil and Platelet Count Recovery Following Allogeneic PBSCT. | 12 (10 to 37) | 12 (10 to 37) |
| percentage of patient surviving | A:Thymoglobulin: 1.7 mg/kg/Day | B:Thymoglobulin: 2.5 mg/kg/Day |
|---|---|---|
| Survival | 71.3 | 62.4 |
| percentage of patients | A:Thymoglobulin: 1.7 mg/kg/Day | B:Thymoglobulin: 2.5 mg/kg/Day |
|---|---|---|
| Treatment Related Mortality | 0 | 0 |
| percentage of participants | A:Thymoglobulin: 1.7 mg/kg/Day | B:Thymoglobulin: 2.5 mg/kg/Day |
|---|---|---|
| Event-free Survival | 62.2 | 44.5 |
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.
| Percent patients relapsing | A:Thymoglobulin: 1.7 mg/kg/Day | B:Thymoglobulin: 2.5 mg/kg/Day |
|---|---|---|
| Relapse | 28 | 50 |
| percentage of participants | A:Thymoglobulin: 1.7 mg/kg/Day | B:Thymoglobulin: 2.5 mg/kg/Day |
|---|---|---|
| Donor Lymphocyte Infusion | 8.9 | 45.5 |
| percentage of participant | A:Thymoglobulin: 1.7 mg/kg/Day | B:Thymoglobulin: 2.5 mg/kg/Day |
|---|---|---|
| Acute Graft-Versus-Host Disease (GVHD) | 27.2 | 4.5 |
| percentage of participants | A:Thymoglobulin: 1.7 mg/kg/Day | B:Thymoglobulin: 2.5 mg/kg/Day |
|---|---|---|
| Chronic Graft-Versus-Host Disease (GVHD) | 23.8 | 31.8 |
Collected over All events collected from first patient accrual up to day 180 or relapse for each subject on each arm.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A:Thymoglobulin: 1.7 mg/kg/Day | — | 7/19 (36.8%) | 19/19 (100%) |
| B:Thymoglobulin: 2.5 mg/kg/Day | — | 12/22 (54.5%) | 22/22 (100%) |
| Event | A:Thymoglobulin: 1.7 mg/kg/Day | B:Thymoglobulin: 2.5 mg/kg/Day |
|---|---|---|
| Fever with Bacteremia +/- abscessInfections and infestations | 3/19 | 6/22 |
| DiarrheaGastrointestinal disorders | 3/19 | 1/22 |
| HepaticGastrointestinal disorders | 2/19 | 0/22 |
| Fever with out bacteremiaInfections and infestations | 2/19 | 2/22 |
| RenalRenal and urinary disorders | 2/19 | 0/22 |
| NauseaGastrointestinal disorders | 0/19 | 2/22 |
| SyncopeNervous system disorders | 1/19 | 1/22 |
| CNS toxicityNervous system disorders | 1/19 | 1/22 |
| Cardiac dysrhythmiaCardiac disorders | 1/19 | 1/22 |
| Hemorrhagic cystitisRenal and urinary disorders | 1/19 | 1/22 |
| Event | A:Thymoglobulin: 1.7 mg/kg/Day | B:Thymoglobulin: 2.5 mg/kg/Day |
|---|---|---|
| Grade 3 neutropeniaBlood and lymphatic system disorders | 19/19 | 22/22 |
| Lymphopenia post conditioningBlood and lymphatic system disorders | 19/19 | 22/22 |
| ThrombocytopeniaBlood and lymphatic system disorders | 19/19 | 22/22 |
| Bacteremia/FeverInfections and infestations | 2/19 | 1/22 |
| NauseaGastrointestinal disorders | 2/19 | 0/22 |
| OcularEye disorders | 0/19 | 2/22 |
| Post transplant neutropeniaBlood and lymphatic system disorders | 1/19 | 1/22 |
| DiarrheaGastrointestinal disorders | 1/19 | 1/22 |
| Urinary tract infectionRenal and urinary disorders | 1/19 | 0/22 |
| RashSkin and subcutaneous tissue disorders | 0/19 | 1/22 |
Subjects able to proceed to transplant.
| Age, Continuous(years) | A:Thymoglobulin: 1.7 mg/kg/Day | B:Thymoglobulin: 2.5 mg/kg/Day | Total |
|---|---|---|---|
| Median | 57 (44 to 69) | 57 (40 to 68) | 57 (40 to 69) |
| Sex: Female, Male(Participants) | A:Thymoglobulin: 1.7 mg/kg/Day | B:Thymoglobulin: 2.5 mg/kg/Day | Total |
|---|---|---|---|
| Female | 7 | 8 | 15 |
| Male | 12 | 15 | 27 |
| Region of Enrollment(participants) | A:Thymoglobulin: 1.7 mg/kg/Day | B:Thymoglobulin: 2.5 mg/kg/Day | Total |
|---|---|---|---|
| United States | 19 | 23 | 42 |
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