Status:
COMPLETED
Vorinostat to Prevent Graft Versus Host Disease Following Reduced Intensity, Related Donor Stem Cell Transplant
Lead Sponsor:
Pavan Reddy, MD
Conditions:
Hematologic Malignancies
Graft vs Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The proposed research study is to test the drug vorinostat, in a new use as an additional medication, with other standard treatments for the prevention of severe acute graft versus host disease (GVHD)...
Eligibility Criteria
Inclusion
- 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 disease.
- 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 years).
- 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).
Exclusion
- 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).
- Pregnancy.
- 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 care).
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00810602
Start Date
January 1 2009
End Date
July 1 2013
Last Update
April 11 2014
Active Locations (2)
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1
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110