Expired Study
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New York, New York 10029


Purpose:

RATIONALE: Alemtuzumab, tacrolimus, and methylprednisolone may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant. 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.


Study summary:

OBJECTIVES: 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.


Criteria:

DISEASE CHARACTERISTICS: - 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


Study is Available At:


Original ID:

CASE1Z04


NCT ID:

NCT00109993


Secondary ID:

P30CA043703


Study Acronym:


Brief Title:

Campath-1H + FK506 and Methylprednisolone for GVHD


Official Title:

Phase II Clinical Trial Incorporating Alemtuzumab (Campath-1H) in Combination With FK506 and Methylprednisolone for Treatment of Severe Acute Graft vs Host Disease


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Case Comprehensive Cancer Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Interven


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

34


Enrollment Type:

Actual


Overall Contact Information

Official Name:Mary Laughlin, MD
Principal Investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Study Dates

Start Date:January 2005
Completion Date:May 2007
Completion Type:Actual
Primary Completion Date:June 2006
Primary Completion Type:Actual
Verification Date:June 2010
Last Changed Date:June 10, 2010
First Received Date:May 3, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Graft-vs-host disease response
Time Frame:1, 2, 3, and 4 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence of serious infections by clinical, radiologic, and microbiologic assessments
Time Frame:1,2,3, and 4 months
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:alemtuzumab
Description:alemtuzumab IV over 2 hours on days 4-6, 18, and 32
Intervention Type:Drug
Name:methylprednisolone
Description:methylprednisolone IV on days 1-3 and then orally or IV on days 4-14
Intervention Type:Drug
Name:tacrolimus
Description: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

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Case Comprehensive Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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