Tacrolimus and Mycophenolate Mofetil in Preventing Acute... | NCT00096096 | Trialant
NCT00096096
Sponsor
Fred Hutchinson Cancer Center
Status
Completed
Last Update Posted
May 13, 2010Estimated
Enrollment
Not provided
Phase
Phase 2
Conditions
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Interventions
mycophenolate mofetil
tacrolimus
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00096096
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1893.00
Secondary IDs
ID
Type
Description
Link
FHCRC-1893.00
CDR0000391026
Registry Identifier
PDQ
Brief Title
Tacrolimus and Mycophenolate Mofetil in Preventing Acute Graft-Versus-Host Disease in Patients With Advanced Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation
Official Title
A Phase II Study of the Combination of Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-Versus-Host Disease
Acronym
Not provided
Organization
Fred Hutchinson Cancer CenterOTHER
Status Module
Record Verification Date
May 2010
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2004
Primary Completion Date
May 2006Actual
Completion Date
Not provided
First Submitted Date
Nov 9, 2004
First Submission Date that Met QC Criteria
Nov 8, 2004
First Posted Date
Nov 9, 2004Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 12, 2010
Last Update Posted Date
May 13, 2010Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Fred Hutchinson Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Tacrolimus and mycophenolate mofetil may be an effective treatment for graft-versus-host disease caused by donor stem cell transplantation.
PURPOSE: This phase II trial is studying how well giving tacrolimus together with mycophenolate mofetil works in preventing acute graft-versus-host disease in patients who are undergoing donor stem cell transplantation for advanced hematologic cancer.
Detailed Description
OBJECTIVES:
Primary
Determine the efficacy of tacrolimus and mycophenolate mofetil in preventing acute graft-vs-host disease in patients with advanced hematologic malignancies undergoing allogeneic peripheral blood stem cell transplantation.
Secondary
Determine the safety of this regimen in these patients.
OUTLINE: This is a non-randomized study.
Patients receive tacrolimus IV continuously or orally twice daily on days -1 to 60 followed by a taper to day 180. Patients also receive mycophenolate mofetil IV over 2 hours or orally twice daily on days 0-60 followed by a taper to day 180. Treatment is discontinued at day 180 in the absence of graft-vs-host disease.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.
Conditions Module
Conditions
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Keywords
graft versus host disease
accelerated phase chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
recurrent adult Hodgkin lymphoma
refractory multiple myeloma
recurrent adult Burkitt lymphoma
chronic idiopathic myelofibrosis
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent mantle cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult lymphoblastic lymphoma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
mycophenolate mofetil
Drug
tacrolimus
Drug
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Efficacy
Secondary Outcomes
Measure
Description
Time Frame
Safety
Area under the curve of plasma mycophenolic acid
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematologic malignancies:
Acute myeloid leukemia beyond first complete remission (CR1)
Acute lymphoblastic leukemia beyond CR1
Chronic myelogenous leukemia in second chronic phase, accelerated phase, or blastic phase