Reduced Intensity Total Body Irradiation + Thymoglobulin Followed by Allogeneic PBSCT
NCT ID: NCT00709592
Last Updated: 2018-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2008-07-21
2017-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ATG 1.7 mg/kg, TBI, transplant
(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.
Thymoglobulin
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.
Total-Body Irradiation
Undergo TBI
Allogeneic PBSCT or BMT
Undergo allogeneic PBSCT or BMT
Tacrolimus
Given PO
Mycophenolate Mofetil
Given PO
ATG 2.5 mg/kg/d, TBI, transplant
(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.
Thymoglobulin
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.
Total-Body Irradiation
Undergo TBI
Allogeneic PBSCT or BMT
Undergo allogeneic PBSCT or BMT
Tacrolimus
Given PO
Mycophenolate Mofetil
Given PO
Interventions
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Thymoglobulin
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.
Total-Body Irradiation
Undergo TBI
Allogeneic PBSCT or BMT
Undergo allogeneic PBSCT or BMT
Tacrolimus
Given PO
Mycophenolate Mofetil
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with HLA compatible related or unrelated stem cell donor, willing and able to serve as an allogenic HSC donor. Unrelated donors have to be matched at HLA-A, B, C and DRB1 loci. A single locus mismatch will be tolerated in the event a more closely matched donor is not available.
* Patients age \>/=40 to \</=70 with an ECOG performance status \< 2
* Patients between 18 and 40 years of age will be eligible only if they have co-morbidities precluding conventional allogeneic transplantation with full intensity myeloablative conditioning
* Adequate cardiac, pulmonary, renal and hepatic function for transplant
* Negative serology for HIV
* Negative serum pregnancy test
* Patients who have received therapeutic radiation to a localized field will be eligible, provided critical structure tolerance doses have not been exceeded
* Patients who have had prior myeloablative autologous transplant will be eligible
Exclusion Criteria
* Evidence of active meningeal or CNS disease
* Prior therapy with rabbit ATG, prior treatment with equine ATG is allowed if more than 3 months ago
* Breast feeding mothers are excluded
40 Years
70 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Amir Toor, MD
Role: PRINCIPAL_INVESTIGATOR
Massey Cancer Center
Locations
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Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Countries
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Related Links
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VCU Massey Cancer Center
Other Identifiers
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NCI-2011-01698
Identifier Type: OTHER
Identifier Source: secondary_id
MCC-11561
Identifier Type: -
Identifier Source: org_study_id
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