- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00144677
Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation
January 24, 2012 updated by: Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute
Open Label Phase II Trial of Sirolimus in Combination With Tacrolimus for Graft-vs-Host Disease Prophylaxis After HLA-Matched, Unrelated, Allogeneic Hematopoietic Stem Cell Transplantation
The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus host disease (GVHD) in patients following stem cell transplant from an unrelated donor.
This trial is designed to test the hypothesis that elimination of methotrexate in the unrelated donor group would lead to less transplant-related toxicity while still preserving the effective control of GVHD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and sirolimus orally once daily starting 3 days before stem cell infusion. This will take place in the hospital where the patient will remain for the duration of the transplant.
- Sirolimus will continue for approximately 100 days at a stable dose, then it will be tapered slowly over the course of weeks to months to prevent a flare in GVHD.
- Patients will be seen in the clinic weekly for the first 2 months after discharge from the hospital. If GVHD is present, tapering schedule will be slower and based on the patient's clinical condition.
- Tacrolimus will also be given orally after the patient is discharged and will be tapered on the same schedule as sirolimus.
- During the year following stem cell transplant, blood tests will be performed to evaluate the immune system and graft versus host disease.
Study Type
Interventional
Enrollment
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Acute myelogenous leukemia(AML) in first or subsequent remission, in untreated first relapse or any treated relapse.
- Acute lymphoblastic leukemia(ALL) in first or subsequent remission, in untreated first relapse or any treated relapse.
- Chronic myelogenous leukemia in first or second chronic stable phase or in accelerated phase.
- Myelodysplastic syndromes or myeloproliferative diseases
- Non-Hodgkin's lymphoma or Hodgkin's disease in second or greater complete remission, in partial remission, or induction failure.
- Chronic lymphocytic leukemia, Rai stage 2-4, which has progressed after initial therapy.
- Matched unrelated donor.
- Age 18-55 years at the time of stem cell transplantation
- ECOG performance status 0-2
- Life expectancy of 100 days without stem cell transplantation
- Total bilirubin < 2.0 mg/dl
- AST < 90 IU
- Serum creatinine < 2.0 mg/dl
- Ejection fraction > 40% by echocardiogram or gated nuclear medicine study.
Exclusion Criteria:
- Uncontrolled infection
- Forced vital capacity or DLCO < 50% predicted for age
- Uncontrolled hypertension
- Prior hematopoietic stem cell transplant
- Evidence of HIV infection or active Hepatitis B or C infection
- Cholesterol > 300 mg/dl
- Relapsed aggressive Burkitt's or Burkitt's-like lymphoma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To determine the feasibility of using a combination of sirolimus and tacrolimus without methotrexate for GVHD prophylaxis after stem cell transplantation.
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Secondary Outcome Measures
Outcome Measure |
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To compare the rates of grade II-IV and III-IV acute GVHD with historical control
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to determine the incidence of 100 day mortality using this GVHD prophylaxis regimen
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to determine the overall survival after one year of this patient population.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Corey Cutler, MD, MPH, Dana-Farber Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2003
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
September 1, 2005
First Submitted That Met QC Criteria
September 1, 2005
First Posted (Estimate)
September 5, 2005
Study Record Updates
Last Update Posted (Estimate)
January 26, 2012
Last Update Submitted That Met QC Criteria
January 24, 2012
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Leukemia, Lymphoid
- Lymphoma
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Hodgkin Disease
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Graft vs Host Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Calcineurin Inhibitors
- Tacrolimus
- Sirolimus
Other Study ID Numbers
- 03-290
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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