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Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Myelogenous Leukemia, AML

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Trial Information

Blockade of PD-1 in Conjunction With the Dendritic Cell/AML Vaccine Following Chemotherapy Induced Remission


- This study is divided into two groups: Group 1 participants will receive the DC AML
Fusion Vaccine and Group 2 participants will receive the CT-011 and the DC AML vaccine.
The first 10 participants will be in Group 1 and the remaining 25 will be in Group 2.

- Group 1 participants will receive the DC AML vaccine and GM-CSF 4-8 weeks after
completion of chemotherapy for acute myelogenous leukemia (AML). GM-CSF is a drug that
stimulates white blood cells and is given with the DC AML Vaccine in an effort to
enhance the effect of the vaccine. Participants in this group will receive 3 doses of
the vaccine at 4 week intervals.

- Group 2 participants will receive infusions of CT-011 4-8 weeks after completion of
chemotherapy for AML. Participants in this group will receive a total of 3 doses of
CT-011 at 6 week intervals. In addition, they will receive a vaccination of the DC AML
vaccine two weeks following each infusion of CT-011.

- All participants will undergo the following procedures: Isolation of tumor cells by
either bone marrow biopsy or blood draw; Initial chemotherapy for AML with standard
therapy; Leukopheresis (collection of white blood cells from the blood).

- All participants will also have blood tests, a physical exam, and an electrocardiogram
prior to each dose of vaccine.

- Four weeks following the final vaccination, participants will undergo a skin test
called "delayed-type hypersensitivity" (DTH). This is an injection of the tumor cells
under the skin to measure how the immune system responds. The tumor cells are broken
up and irradiated to prevent their growth.


Inclusion Criteria:



Screening:

- Patients with AML at initial diagnosis or at first relapse

- 18 years of age or older

- ECOG Performance Status 0-2

- Life expectancy of greater than 9 weeks

- Laboratory values within limits outlined in the protocol

- Women of child-bearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation

Prior to Cell Collections for Dendritic Cell Generation:

- Patients must have obtained complete remission with chemotherapy defined by the
absence of circulating blasts, and less then 5% blasts on bone marrow examination
following hematopoietic recovery

- Resolution of all chemotherapy related Grade III-IV toxicity as per CTC criteria 4.0

- Laboratory values as outlined in the protocol

- For patients with evidence of minimal residual disease prior to vaccination,
assessment of minimal residual disease status by cytogenetics or FISH will be
followed post vaccination

Prior to Post-Chemotherapy Immunotherapy:

- Resolution of all chemotherapy related grade III-IV toxicity

- Laboratory values as outlined in the protocol

- At least 2 doses of fusion vaccine produced

Exclusion Criteria:

Screening:

- Active or history of autoimmune disorders/conditions including Type 1 diabetes. Type
II diabetes, vitiligo or stable hyperthyroidism will not be considered exclusion
criteria

- HIV positive

- Significant cardiac disease characterized by symptomatic congestive heart failure,
unstable angina pectoris, clinically significant cardiac arrhythmia

- Pregnant women

- Individuals with a history of a different malignancy are ineligible except for
circumstances outlined in the protocol document

Prior to Cell Collection for Dendritic Cell Generation:

- Serious intercurrent illness such as infection requiring IV antibiotics, or
significant cardiac disease characterized by significant arrhythmia, ischemic
coronary disease or congestive heart failure

- Patients who choose to proceed with allogeneic or autologous transplant at the time
of remission will not be vaccinated and will come off study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity

Outcome Description:

First Stage: To assess the toxicity associated with treating AML patients with DC AML fusion cells in the post-chemotherapy setting

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Jacalyn Rosenblatt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

09-412

NCT ID:

NCT01096602

Start Date:

May 2010

Completion Date:

Related Keywords:

  • Acute Myelogenous Leukemia
  • AML
  • Dendritic Cell/AML vaccine
  • CT-011
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215