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

• Status: Terminated
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: PDL BioPharma, Inc.; Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Bortezomib; Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Sirolimus

Criteria

Inclusion Criteria:

1. Patients with hematologic malignancies, who are at high risk of complications after conventional myeloablative transplantation

2. 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

3. Patient age greater than 18

4. Performance status 0-2

5. Life expectancy of > 100 days without transplantation

6. Written informed consent must be obtained in all cases from the patient

Exclusion Criteria:

1. Pregnancy

2. Prior Allogeneic Stem Cell Transplantation from any donor

3. Evidence of HIV infection or active Hepatitis B or C infection

4. Heart failure uncontrolled by medications

5. Total bilirubin > 2.0 mg/dl that is due to hepatocellular dysfunction

6. AST > 90

7. Cholesterol > 300 mg/dl or Triglycerides > 400 mg/dl while adequately treated

8. Uncontrolled bacterial, viral or fungal infection

9. Requirement for voriconazole at the time of hospital admission