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A Phase 1 Study of DEC205mAb-NY-ESO-1 Fusion Protein (CDX-1401) Given With Adjuvant PolyICLC in Conjunction With 5-Aza-2'Deoxycytidine (Decitabine) in Patients With MDS or Low Blast Count AML

Phase 1
18 Years
Not Enrolling
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Myeloid Leukemia, Refractory Anemia With Excess Blasts in Transformation, Untreated Adult Acute Myeloid Leukemia

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Trial Information

A Phase 1 Study of DEC205mAb-NY-ESO-1 Fusion Protein (CDX-1401) Given With Adjuvant PolyICLC in Conjunction With 5-Aza-2'Deoxycytidine (Decitabine) in Patients With MDS or Low Blast Count AML


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.


I. To evaluate NY-ESO-1 specific cellular and humoral immunity by determination of NY-ESO-1
specific antibody, and T-cell clones following standard treatment with
5-aza-2'-deoxycytidine (decitabine) in conjunction with immune sensitization with Anti-DEC
205-NY-ESO-I fusion protein (CDX-1401).

II. To determine the impact of decitabine treatment on peripheral blood cells from patients
treated in this manner on NY-ESO-1 target gene expression, NY-ESO protein expression,
NY-ESO-1 promoter methylation, and global deoxyribonucleic acid (DNA) methylation.


I. To record the response rate (complete response, partial response and hematological
improvement) in myelodysplastic syndrome (MDS) or low blast count acute myeloid leukemia
(AML) patients treated with the combination in order to provide descriptive characteristics.


Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 subcutaneously (SC) and
intradermally (ID) and poly-ICLC subcutaneously (SC) on day -14 and day 15 of courses 1-4.
Patients also receive decitabine intravenously (IV) over 1 hour on days 1-5. Treatment
repeats every 28 days for up to 4 courses in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up at 30, 60, 90, and 180 days.

Inclusion Criteria:

- Subjects with a confirmed diagnosis of:

- International Prognostic Scoring System (IPSS) intermediate-I, intermediate-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
and for the duration of study participation; 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 Criteria:

- 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(I 6;16); t(8;21) or t(1 5;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 (eg. 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

- Subjects with other prior malignancies must be disease free for at least 3 years

- Subjects previously treated with an allogeneic stem cell transplant

Type of Study:


Study Design:

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

Outcome Measure:

Grade 3+ adverse event and serious adverse event (SAE) rate, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0

Outcome Description:

Toxicity rates will be described using upper one-sided 95% Clopper Pearson binomial confidence intervals.

Outcome Time Frame:

Up to 30 days after last dose of study treatment

Safety Issue:


Principal Investigator

Elizabeth Griffiths

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:

I 227712



Start Date:

June 2013

Completion Date:

Related Keywords:

  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Chronic Myelomonocytic Leukemia
  • de Novo Myelodysplastic Syndromes
  • Previously Treated Myelodysplastic Syndromes
  • Recurrent Adult Acute Myeloid Leukemia
  • Refractory Anemia With Excess Blasts in Transformation
  • Untreated Adult Acute Myeloid Leukemia
  • Congenital Abnormalities
  • Anemia
  • Anemia, Refractory
  • Anemia, Refractory, with Excess of Blasts
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute
  • Anemia, Aplastic



Roswell Park Cancer Institute Buffalo, New York  14263