Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation
This study has been completed.
Information provided by (Responsible Party):
Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute
First received: September 1, 2005
Last updated: January 24, 2012
Last verified: March 2009
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.
Acute Myelogenous Leukemia
Graft Versus Host Disease
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||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
Primary Outcome Measures:
- To determine the feasibility of using a combination of sirolimus and tacrolimus without methotrexate for GVHD prophylaxis after stem cell transplantation.
Secondary Outcome Measures:
- To compare the rates of grade II-IV and III-IV acute GVHD with historical control
- to determine the incidence of 100 day mortality using this GVHD prophylaxis regimen
- to determine the overall survival after one year of this patient population.
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2006 (Final data collection date for primary outcome measure)
- 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.
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144677
|Dana-Farber Cancer Center
|Boston, Massachusetts, United States, 02115 |
Dana-Farber Cancer Institute
||Corey Cutler, MD, MPH
||Dana-Farber Cancer Institute
No publications provided
||Corey S. Cutler, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 1, 2005
||January 24, 2012
||United States: Institutional Review Board
Keywords provided by Dana-Farber Cancer Institute:
Graft versus Host Disease
Stem cell transplant
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Graft vs Host Disease
Bone Marrow Diseases
Immune System Diseases
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type