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©2022 Stanford Medicine
Not Recruiting
Trial ID: NCT00895934
A Phase 1/2 Study of Vorinostat (Zolinza®) in Combination With Gemtuzumab Ozogamicin (Mylotarg®) and Azacitidine (Vidaza®) in Patients 50 Years of Age and Older With Relapsed/Refractory Non-APL Acute Myeloid Leukemia (AML)
Professor of Medicine (Hematology)
Inclusion Criteria:
- Prior morphological diagnosis of acute myeloid leukemia (AML) other then acute
promyelocytic leukemia (APL) according to the 2001 WHO criteria; patients with
biphenotypic AML are eligible
- Need for first salvage chemotherapy for persistent or relapsing disease, defined by
standard criteria, after at least one course of conventional chemotherapy
- A bone marrow biopsy is not required but should be obtained if the aspirate is dilute,
hypocellular, or not aspirable; outside marrow exams performed within the stipulated
time period are acceptable if the slides are reviewed at the study institution
- Flow cytometric analysis of the marrow aspirate per institutional practice guidelines
- Duration of first complete remission (CR1) < 12 months (or primary resistant disease)
- Patients with prior autologous or allogeneic hematopoietic cell transplantation (HCT)
if relapse occurs 6-12 months post-transplant
- ECOG/WHO/Zubrod performance status of 0-3 within 14 days prior to registration
- Off any active therapy for AML except hydroxyurea for at least 14 days prior to study
registration, with resolution of all grade 3 and 4 non-hematological toxicities
- Willingness to discontinue taking any medications known to cause a risk of Torsades de
Pointes
- Bilirubin =< 1.5 x Institutional Upper Limit of Normal (IULN) unless elevation is due
to hepatic infiltration by AML, Gilbert's syndrome, or hemolysis (within 7 days prior
to registration)
- SGOT (AST) and SGPT (ALT) =< 1.5 x IULN unless elevation is due to hepatic
infiltration by AML (within 7 days prior to registration)
- Serum creatinine =< 1.5 x IULN (within 7 days prior to registration)
- No clinical or radiographical evidence of heart failure
- white blood cell (WBC) < 25,000/uL within 3 days prior to registration
- Patients with symptoms/signs of hyperleukocytosis or WBC > 100,000/uL can be treated
with leukapheresis prior to enrollment
- Collection of bone marrow and peripheral blood specimens for correlative studies prior
to study treatment is highly recommended; peripheral blood only is acceptable if the
peripheral blast count is > 5,000/uL and > 50% of total WBC
- Must agree to use adequate contraception prior to and during the study
- Can understand and sign a written informed consent document; a legally authorized
representative can provide consent if the patient is unable
Exclusion Criteria:
- Remission or second or later relapse
- Diagnosis of another malignancy, unless diagnosed at least 2 years earlier and
disease-free for at least 6 months after completion of curative intent therapy except:
- Treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial
neoplasia, if definitive treatment has been completed
- Organ-confined prostate cancer with no evidence of recurrent or progressive
disease based on prostate-specific antigen (PSA) values if hormonal therapy has
been initiated or a radical prostatectomy was performed
- Refractory/relapsing blast crisis of chronic myeloid leukemia (CML)
- Prior anti-AML treatment with GO, histone deacetylase (HDAC) inhibitor (including the
use of valproic acid for control of seizure activity or other purposes), or
demethylating agent
- Known hypersensitivity to GO, vorinostat, azacitidine, or mannitol
- Possible central nervous system (CNS) involvement with leukemia unless a lumbar
puncture confirms no leukemic blasts in the cerebralspinal fluid (CSF)
- HIV-positive patients with cluster of differentiation (CD)4 count is < 200 cells/uL or
if AIDS-related complications
- Pregnancy; breastfeeding should be discontinued if the mother is treated with
vorinostat, azacitidine, and GO
- Uncontrolled systemic infection, despite appropriate antibiotics or other treatment)
- Receipt of any other investigational agents
drug: azacitidine
drug: gemtuzumab ozogamicin
drug: vorinostat
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061