Sirolimus, Mycophenolate Mofetil and Bortezomib as Graft-Versus-Host Disease (GVHD) Prophylaxis After Reduced Intensity Conditioning (RIC) Hematopoietic Stem Cell Transplantation

Stopped early · Phase 2

Conditions studied: Graft-vs-Host Disease

In brief

This trial will test the hypothesis that the combination of sirolimus, mycophenolate mofetil, and bortezomib will be effective in preventing both acute and chronic GVHD after reduced intensity allogeneic stem cell transplantation.

Key facts

Study ID: NCT00548717
Run by: Dana-Farber Cancer Institute
People needed: 15
Starts: 2007-10-01
Expected to finish: 2013-09-01
Last updated by the study team: 2014-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with hematologic malignancies, who are at high risk of complications after conventional myeloablative transplantation
Patients must have a 6/6 matched, related donor. Matching at HLA Class II will be based on PCR of sequence specific primers (SSP). Among family member transplants, serologic matching at Class I is sufficient
Patient age greater than 18
Performance status 0-2
Life expectancy of > 100 days without transplantation
Written informed consent must be obtained in all cases from the patient

You may not qualify if…

Pregnancy
Prior Allogeneic Stem Cell Transplantation from any donor
Evidence of HIV infection or active Hepatitis B or C infection
Heart failure uncontrolled by medications
Total bilirubin > 2.0 mg/dl that is due to hepatocellular dysfunction
AST > 90
Cholesterol > 300 mg/dl or Triglycerides > 400 mg/dl while adequately treated
Uncontrolled bacterial, viral or fungal infection
Requirement for voriconazole at the time of hospital admission

Where it is running

Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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