Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse (VZ-AML-PI-0129)
Condition: Leukemia; AML; MDS
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes
Intervention: Azacitidine
Intervention description: 32 mg/m^2 given through a needle under the skin for five consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles.
Intervention MeSH terms: Azacitidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Leukemia; Acute myelogenous leukemia; AML; Myelodysplastic syndrome; MDS; Remission; Allogeneic stem cell transplant; Allotx; Azacitidine; 5-Azacitidine; 5-aza; Vidaza; 5-AZC; AZA-CR; Ladakamycin; NSC-102816

Summary:

      The goal of this clinical research study is to learn if Vidaza (azacitidine) will help to
      control the disease in patients with AML, CMML, or MDS after an allogeneic (donor) stem cell
      transplant. The safety of this drug will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with a diagnosis of AML (World Health Organization classification: >=20%
             blasts in the bone marrow and / or peripheral blood) or MDS (International Prognostic
             Scoring System intermediate-1 or higher) that at the time of allogeneic
             transplantation were in: - Induction Failure, relapsed disease or second or greater
             remission; patients in first complete remission that required more than 1 cycle of
             treatment to achieve the remission, or that have AML evolving from MDS, or that had
             the following abnormalities: FLT3 mutation, deletion of chromosome 5 or 7, MLL gene
             rearrangement, or more than or equal to 3 cytogenetics abnormalities. Patients with de
             novo or therapy-related MDS, CMML, or AML are also eligible, regardless of
             cytogenetics or molecular rearrangements.

          2. Biphenotypic Leukemia that at the time of allogeneic transplantation was in induction
             failure, relapsed disease, first, second or greater remission.

          3. Patients must be in complete remission post transplant.

          4. Patient may be enrolled 40 to 100 days after transplant.

          5. Age 18 to 75 years old.

          6. Serum creatinine < 1.8 mg/dL or creatinine clearance greater or equal than 40 cc/min
             as defined by the Cockcroft-Gault Equation*. a. Males(mL/min):(140-age)*IBW(kg) /
             72*(serum creatinine(mg/dl)) b. Females(mL/min):0.85*(140-age)*IBW(kg) / 72*(serum
             creatinine(mg/dl)).

          7. Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome).

          8. SGPT </= 200 IU/ml unless related to patient's malignancy.

          9. Be able to understand and sign informed consent.

        Exclusion Criteria:

          1. Active uncontrolled infection.

          2. Presence of uncontrolled graft-versus-host disease.

          3. Patients that underwent allogeneic transplantation as a treatment of graft failure.

          4. Pregnancy or breast-feeding (women of childbearing potential, any female who has
             experienced menarche and who has not undergone surgical sterilization or is not
             post-menopausal with a positive serum pregnancy test.

          5. Known or suspected hypersensitivity to azacitidine or mannitol.

          6. Patients with advanced malignant hepatic tumors.