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Phase II Trial of Vorinostat Plus Tacrolimus & Mycophenolate to Prevent Graft Versus Host Disease Following Reduced Intensity Conditioning Related Donor Allogeneic Transplant


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hematologic Malignancies, Graft vs Host Disease

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Trial Information

Phase II Trial of Vorinostat Plus Tacrolimus & Mycophenolate to Prevent Graft Versus Host Disease Following Reduced Intensity Conditioning Related Donor Allogeneic Transplant


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess if the addition of vorinostat to a standard GVHD prophylaxis regimen, can reduce the rate of grades 2-4 acute GVHD from 42% to 25%, as compared to historical control patients.

Outcome Time Frame:

100 days

Safety Issue:

Yes

Principal Investigator

Pavan Reddy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

umcc 2008.095

NCT ID:

NCT00810602

Start Date:

January 2009

Completion Date:

June 2015

Related Keywords:

  • Hematologic Malignancies
  • Graft Vs Host Disease
  • Neoplasms
  • Graft vs Host Disease
  • Hematologic Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110
University of Michigan Cancer CenterAnn Arbor, Michigan  48109