Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
34 participants
INTERVENTIONAL
2005-01-31
2007-05-31
Brief Summary
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PURPOSE: This phase II trial is studying how well giving alemtuzumab together with tacrolimus and methylprednisolone works in treating acute graft-versus-host disease in patients who have undergone donor stem cell transplant.
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Detailed Description
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Primary
* Determine the 4-week rate of complete response in patients with severe acute graft-vs-host disease (GVHD) treated with alemtuzumab, tacrolimus, and methylprednisolone within 100 days after undergoing allogeneic stem cell transplantation.
Secondary
* Determine the best response at 4 and 12 weeks in patients treated with this regimen.
* Determine 6-month survival of patients treated with this regimen.
* Determine the rate of infectious complications in patients treated with this regimen.
* Determine rate of chronic GVHD in patients treated with this regimen.
OUTLINE: This is an open-label, single-blind, multicenter study.
Patients receive methylprednisolone IV on days 1-3 and then orally or IV on days 4-14; tacrolimus IV continuously on days 1-7 and then orally once or twice daily on days 8-180, followed by a taper in the absence of chronic graft-vs-host disease; and alemtuzumab IV over 2 hours on days 4-6, 18, and 32. Treatment continues in the absence of unacceptable toxicity or the development of serious infection.
After completion of study treatment, patients are followed at 2 and 4 weeks.
PROJECTED ACCRUAL: A total of 9-34 patients will be accrued for this study within 8-12 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Interventions
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alemtuzumab
alemtuzumab IV over 2 hours on days 4-6, 18, and 32
methylprednisolone
methylprednisolone IV on days 1-3 and then orally or IV on days 4-14
tacrolimus
tacrolimus IV continuously on days 1-7 and then orally once or twice daily on days 8-180, followed by a taper in the absence of chronic graft-vs-host disease
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of acute graft-vs-host disease (GVHD)
* Clinical grade C or D disease
* No grade C disease with single organ skin involvement
* Has undergone allogeneic stem cell transplantation within the past 100 days
* Absolute neutrophil count \> 500/mm\^3 (donor-derived \[\> 60% by peripheral blood lymphocyte chimerism analyses\])
* No development of GVHD after prior donor lymphocyte infusion
* Must have received prior prophylactic cyclosporine or tacrolimus at the onset of acute GVHD
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* No serologic evidence of active hepatitis B or C infection
Renal
* Creatinine ≤ 3.5 mg/dL
* No requirement for dialysis
Cardiovascular
* No requirement for vasopressors
Pulmonary
* No requirement for a ventilator
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* No known HIV positivity
* No active uncontrolled infection
* No other organ dysfunction
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Ireland Cancer Center at University Hospitals Case Medical Center,Case Comprehensive Cancer Center
Principal Investigators
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Mary Laughlin, MD
Role: PRINCIPAL_INVESTIGATOR
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Locations
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Mt. Sinai Medical Center
New York, New York, United States
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Texas Transplant Institute
San Antonio, Texas, United States
Countries
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Other Identifiers
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CASE-CWRU-1Z04
Identifier Type: OTHER
Identifier Source: secondary_id
CWRU-060419
Identifier Type: -
Identifier Source: secondary_id
CASE-1Z04
Identifier Type: OTHER
Identifier Source: secondary_id
CASE1Z04
Identifier Type: -
Identifier Source: org_study_id
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