Thymoglobulin, Sirolimus and Mycophenolate Mofetil for Prevention of Acute Graft-Versus-Host Disease (GVHD)
NCT ID: NCT00506948
Last Updated: 2020-09-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
13 participants
INTERVENTIONAL
2006-09-30
2010-10-31
Brief Summary
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Primary Objective: To determine efficacy and toxicity of a regimen of thymoglobulin, sirolimus and mycophenolate mofetil for prevention of acute GVHD after allogeneic stem cell transplantation from human leukocyte antigen (HLA) identical related or unrelated donors.
Secondary Objective: To assess engraftment, chronic GVHD, relapse and survival.
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Detailed Description
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If you are found to be eligible to take part in this study, you will receive rATG through a needle in your vein over 3-4 hours on each of the 4 days before the stem cell transplant.
Beginning 2 days before the transplant, you will take sirolimus by mouth once per day. You will continue to receive sirolimus until 90 days after the transplant. Beginning on Day 60, you will start taking increasingly lower doses of the study drug. This is done so you can taper down slowly, and be off of the drug on Day 90.
Beginning on the day of the transplant, you will take MMF by mouth 2 times a day. You will continue to take MMF until 27 days after the transplant.
Every week (for the first 90-100 days after the transplant) you will have study visits. At this visit, you will have a physical exam. Blood (about 1-2 tablespoons) will be drawn for routine tests.
You will remain on study for up to 90 days after transplantation. You will be taken off study if intolerable side effects occur.
Starting on Day 90 after the transplant, you will continue to follow up with your transplant doctor at least every 3 months through 1 year after the transplant. During these visits you will have physical exams. Blood (about 1-2 tablespoons) will be drawn for routine tests. Your doctor may request additional testing.
This is an investigational study. RATG, sirolimus, and MMF are all FDA approved for their use in the transplantation of solid organs (like kidney and liver). All 3 drugs are commercially available. This particular combination and dose schedule is considered investigational. Up to 30 patients will take part in this study. All will be enrolled at M.D. Anderson.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Thymoglobulin + Sirolimus + MMF
Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
Mycophenolate Mofetil (MMF)
15 mg/kg by vein or by mouth every 12 hours.
Thymoglobulin
1.5 mg/kg by vein daily for 4 days
Sirolimus
6 mg daily by mouth for 1 day, followed by 2 mg daily for 1 day.
Stem Cell Transplant
Stem cell infusion on Day 0.
Interventions
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Mycophenolate Mofetil (MMF)
15 mg/kg by vein or by mouth every 12 hours.
Thymoglobulin
1.5 mg/kg by vein daily for 4 days
Sirolimus
6 mg daily by mouth for 1 day, followed by 2 mg daily for 1 day.
Stem Cell Transplant
Stem cell infusion on Day 0.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. HLA-identical sibling or matched unrelated donor transplants not eligible for protocols of higher priority.
3. Age 18-75 years.
4. Bilirubin \</=1.5 mg/dl, serum glutamic-pyruvic transaminase (SGPT) \</= 200 IU/ml.
5. Creatinine \</=1.6 mg/dl.
Exclusion Criteria
2. Patients can not have received prior treatment with gemtuzumab.
3. Planned conditioning chemotherapy for transplant can not include gemtuzumab.
4. Planned conditioning chemotherapy for transplant can not include the busulfan and cyclophosphamide regimen.
5. HIV seropositivity
6. Uncontrolled infection, not responding to adequate antimicrobial therapy after 7 days of treatment. The protocol PI is the final arbiter of eligibility.
7. Pregnancy
8. Inability to sign consent.
9. Patients who are past recipients of allogeneic or autologous stem cell transplants from any source.
18 Years
75 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Amin Alousi, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas (UT) MD Anderson Cancer Center Official Website
Other Identifiers
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2006-0435
Identifier Type: -
Identifier Source: org_study_id
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