Phase II Trial of Vorinostat Plus Tacrolimus & Mycophenolate to Prevent Graft Versus Host Disease Following Reduced Intensity Conditioning Related Donor Allogeneic Transplant
- Have a 7/8 or 8/8 HLA A, B, C and DR, HLA-matched related donor willing and able to
donate allogeneic stem cells.
- For patients with multiple myeloma, CLL, and lymphoma: must be in CR, PR, or stable
- For MDS, acute leukemia or CML: must have <20% blasts on marrow exam.
- For all other diseases: must have non-refractory disease.
and meet at least ONE of the next three criteria:
- Any patient ≥ 18 years of age with a hematological malignancy and not considered a
candidate for allogeneic myeloablative transplant due to illness and/or age (≥55
- Any patient ≥ 18 years of age who has relapsed following prior autologous or
allogeneic transplant for a hematologic malignancy.
- Any patient ≥ 18 years of age diagnosed with a hematological malignancy for which
reduced intensity transplant is institutionally preferred over myeloablative
transplant (eg, chronic lymphocytic leukemia).
- Less than 18 years of age.
- Currently taking any HDAC inhibitors, or have taken an HDAC inhibitor within 30 days
of the trial.
- Positive serum tests for HIV, HTLV1 / HTLV2.
- Detectable hepatitis B virus (HBV), hepatitis C (HCV) or Epstein-Barr (EBV).
- One or more of the following organ system function criteria
- Cardiac: Ejection fraction ≤ 40%
- Renal: Estimated or actual GFR ≤ 40 ml/min (corrected for BSA)
- Pulmonary: FEV1, FVC, or DLCO ≤ 40% predicted
- Hepatic: Total bilirubin ≥3 mg% and AST/ALT >5 x institutional normal for age
- Karnofsky score ≤50 (Requires considerable assistance and frequent medical
- Persistent invasive infections not controlled by antimicrobial medication.
- Any physical or psychological condition that, in the opinion of the investigator,
would pose unacceptable risk to the patient.