Maraviroc in Patients Undergoing Non-Myeloablative Allogeneic Stem-Cell Transplantation
NCT ID: NCT00948753
Last Updated: 2022-05-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
38 participants
INTERVENTIONAL
2009-06-30
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1: 150mg Maraviroc
150mg twice daily
Maraviroc 150 MG
Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
Phase 1: 300mg Maraviroc
300mg twice daily
Maraviroc 300 mg
Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
Phase 2: 300mg Maraviroc
300mg twice daily
Maraviroc 300 mg Phase II
Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
Interventions
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Maraviroc 150 MG
Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
Maraviroc 300 mg
Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
Maraviroc 300 mg Phase II
Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* meet institutional eligibility criteria for allogeneic SCT. Significant criteria are:
* Renal function: Serum creatinine \<2; or calculated creatinine clearance \> 40 mL/min/1.72m2;
* Hepatic function: Baseline direct bilirubin, ALT or AST lower than three times the upper limit of normal;
* Pulmonary disease: FVC or FEV1 \> 40% predicted; Cardiac ejection fraction \> 40%.
Exclusion Criteria
* Patients who are not undergoing standard non-myeloablative SCT with Flu/Bu conditioning and Tax/MTX GVHD prophylaxis
* Patients with uncontrolled bacterial, viral or fungal infections
* Patients who take strong inducers or inhibitors of the CYP450A4
* Patients receiving other investigational drugs for GVHD
* Women who are pregnant, plan to become pregnant or are breastfeeding
18 Years
ALL
No
Sponsors
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Abramson Cancer Center at Penn Medicine
OTHER
Responsible Party
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Principal Investigators
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David Porter, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
References
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Reshef R, Luger SM, Hexner EO, Loren AW, Frey NV, Nasta SD, Goldstein SC, Stadtmauer EA, Smith J, Bailey S, Mick R, Heitjan DF, Emerson SG, Hoxie JA, Vonderheide RH, Porter DL. Blockade of lymphocyte chemotaxis in visceral graft-versus-host disease. N Engl J Med. 2012 Jul 12;367(2):135-45. doi: 10.1056/NEJMoa1201248.
Other Identifiers
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UPCC 04708
Identifier Type: -
Identifier Source: org_study_id
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