Status:
COMPLETED
DEC-205/NY-ESO-1 Fusion Protein CDX-1401and Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Acute Myeloid Leukemia
Alkylating Agent-Related Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and immune response to DEC-205/NY-ESO-1 fusion protein CDX-1401 and decitabine in patients with myelodysplastic syndrome or acute myeloid leukemia. DEC-205-...
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate the safety of Anti-DEC-205-NY-ESOI (CDX-1401) fusion protein (DEC-205/NY-ESO-1 fusion protein CDX-1401) given in combination with decitabine 20 mg/m\^2 intravenously. ...
Eligibility Criteria
Inclusion
- Subjects with a confirmed diagnosis of:
- International Prognostic Scoring System (IPSS) intermediate-I, interrnediate-2 or high-risk MDS including chronic myelomonocytic leukemia (CMML) or
- Low blast count AML with =\< 30% blasts previously classified as refractory anemia with excess blasts in transformation who have not been previously treated with a hypomethylating agent
- Patients with IPSS intermediate-1 disease with an isolated deletion of chromosome 5q must have previously failed treatment with lenalidomide
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
- Total bilirubin =\< 2 x upper limit of normal (ULN)
- Aspartate transaminase (AST/serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine transaminase (ALT/serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x ULN
- Serum creatinine =\< 1.5 x ULN
- Any human leukocyte antigen (HLA) type
- Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after the last treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion
- Subjects with life-threatening illnesses other than MDS, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at risk
- AML associated with inv(16); t(16;16); t(8;21) or t(15;17)
- Subjects with uncontrolled or symptomatic arrhythmias, or any class 3 or 4 cardiac disease as defined by the New York Heart Association functional classification
- Subjects with symptomatic central nervous system (CNS) disease which is not adequately controlled
- Subjects who have received prior radiation therapy for extramedullary disease within 2 weeks of first dose
- Subjects with human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Subjects who are being treated with systemic corticosteroids
- Subjects who have hypersensitivity to decitabine
- History of auto-immune disease (e.g. thyroiditis, lupus) except vitiligo
- Pregnant or nursing female subjects
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug
- Received an investigational agent within 30 days prior to enrollment
- Active malignancy with the exception of basal cell carcinoma, non-melanoma skin cancer, cervical carcinoma-in-situ; other prior malignancies in remission for less than 1 year
- Subjects previously treated with an allogeneic stem cell transplant
Key Trial Info
Start Date :
July 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01834248
Start Date
July 30 2013
End Date
March 21 2016
Last Update
July 22 2022
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263