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Dendritic Cell/AML Fusion Cell Vaccine Following Allogeneic Transplantation in AML Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03679650
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : November 1, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jacalyn Rosenblatt, MD, Dana-Farber Cancer Institute

Brief Summary:

This research study is studying a cancer vaccine called Dendritic Cell/AML Fusion vaccine (DC/AML vaccine) as a possible treatment for Acute Myelogenous Leukemia (AML).

The interventions involved in this study are:

  • Dendritic Cell/AML Fusion vaccine (DC/AML vaccine)
  • Decitabine, a chemotherapy drug

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Drug: decitabine Biological: DC/AML fusion cells Phase 1

Detailed Description:

This research study is a Phase I clinical trial, which tests the safety of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. This study is investigating the DC/AML vaccine with and without the drug decitabine as a possible treatment for AML in the post-transplant setting.

The FDA (the U.S. Food and Drug Administration) has not approved the DC/AML vaccine as a treatment for any disease.

The FDA has approved decitabine as a treatment option for this disease.

The FDA has not approved the combination of the DC/AML vaccine with decitabine as a treatment option for any disease,

In this research study, the investigators are determining if the DC/AML vaccine can be used safely in subjects with acute leukemia after they have undergone a transplant, and whether the DC/AML vaccine alone is capable of producing immune responses against leukemia. Cancer cells are foreign to the body and have unique markers that distinguish them from normal cells.

These markers can potentially serve as targets for the immune system. An immune response is any reaction by the immune system; a complex system that is responsible for distinguishing us from everything foreign to us, and for protecting us against infections and foreign substances.

The DC/AML vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells. Unlike a standard vaccine that is used to prevent infections, cancer vaccines are being studied to see if they can fight cancers that are already in the body. Laboratory studies have shown that when dendritic cells and tumor cells are brought together, the dendritic cells can stimulate immune responses against the tumor and, in some cases, cause the tumor to shrink.

Decitabine is thought to act as an anti-metabolite. It seems to work by having a toxic effect on the abnormal bone marrow cells. It also appears to affect the DNA in genes that control cell growth. This promotes normal specialization and blood cell growth, so that the body is better able to make red blood cells, white blood cells, and platelets.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Trial of Dendritic Cell/AML Fusion Cell Vaccine Alone and in Conjunction With Decitabine Following Allogeneic Transplantation in AML Patients
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2024


Arm Intervention/treatment
Experimental: AML Patient who are undergoing allogeneic transplantation
  • Patients will be vaccinated with DC/AML fusion cells
  • Four days of GM-CSF given subcutaneously at the site of vaccination
  • Patients will receive 2 vaccines, 3 weeks apart, with the potential for a booster vaccine
  • Patients will be treated with 5 days of decitabine in the post-transplant setting
Drug: decitabine
Decitabine is thought to act as an anti-metabolite. It seems to work by having a toxic effect on the abnormal bone marrow cells.

Biological: DC/AML fusion cells
An investigational agent that tries to help the immune system to recognize and fight against cancer cells

Experimental: AML Patient who are undergoing transplantation
  • Patients will be vaccinated with DC/AML fusion cells
  • Four days of GM-CSF given subcutaneously at the site of vaccination
  • Patients will receive 2 vaccines, 3 weeks apart, with the potential for a booster vaccine
Biological: DC/AML fusion cells
An investigational agent that tries to help the immune system to recognize and fight against cancer cells




Primary Outcome Measures :
  1. The fold-increase in AML specific T cells in the peripheral blood and bone marrow [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Complete Remission [ Time Frame: 12 months ]
  2. Complete Remission with Incomplete Count Recovery [ Time Frame: 12 Months ]
  3. Complete Remission with Incomplete Platelet Recovery [ Time Frame: 12 months ]
  4. Partial Remission (PR) [ Time Frame: 12 months ]
  5. Rate of Relapse [ Time Frame: 12 months ]
  6. Stable Disease [ Time Frame: 12 Months ]
  7. Relapse free survival [ Time Frame: 12 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with AML who have undergone AML cell harvest and cryopreservation as per protocol 16-593 or companion protocol 18-232.
  • Patients must have had a minimum of 5x107 cells cryopreserved.
  • Patients must be day 25-45 following allogeneic transplantation from either:

    • Group A: HLA 8/8 or 7/8 matched related donor or HLA 8/8 matched unrelated donor, as determined by antigen or allele level typing at HLA A,B,C, and HLA DRB1.

OR

  • Group B: Haplo-identical donor

    • Patients must be ≥ 18 years old
    • ECOG performance status ≤2 (Appendix A)
    • Participants must have normal organ and marrow function as defined below:
  • Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease)
  • AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal
  • Creatinine ≤ 2.0 mg/dl
  • Absolute neutrophil count > 1000
  • Platelet count > 50,000

    • The effects of DC/AML fusion cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (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 participating in this study, she should inform her treating physician immediately.
    • No evidence of ongoing grade 2 or higher aGVHD
    • Must be on prednisone <20mg or other steroid equivalent
    • Donor chimerism of bone marrow >60%
    • Resolution of all transplant related grade III-IV toxicity as per CTC criteria 4.0
    • Complete remission defined by absence of circulating blasts and less than 5% blasts in the bone marrow
    • Ability to understand and the willingness to sign a written informed consent document.

Eligibility Prior to Initiating Vaccination (Groups A and B)

  • Assessments to be done between Day 45-75 post-transplant.
  • At least 2 doses of fusion vaccine were produced
  • No ongoing grade II-IV acute GVHD
  • Prednisone requirement of < 20mg a day or steroid equivalent
  • Participants must have normal organ and marrow function as defined below:

    • Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease)
    • AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal
    • Creatinine ≤ 2.0 mg/dl
    • Absolute neutrophil count > 1000
    • Platelet count > 50,000
  • No uncontrolled acute infection
  • No CTCAE grade ≥ 3 non-hematologic toxicity
  • No serious intercurrent illness such as active acute infection, or significant cardiac disease characterized by clinically significant arrhythmia, active ischemic coronary disease or symptomatic congestive heart failure.
  • Participants must be in a complete remission

Pre-Treatment Criteria Prior to Decitabine (Group A Cohort 2)

  • Assessments to be done within 3 days prior to initiation of therapy.
  • Participants must have normal organ and marrow function as defined below:
  • Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease)

    • AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal
    • Creatinine ≤ 2.0 mg/dl
    • Absolute neutrophil count > 1000
    • Platelet count > 50,000

Exclusion Criteria:

  • Because of compromised cellular immunity, patients with a known history of HIV are excluded
  • Leukemia with active CNS involvement
  • Patients must not be pregnant. All premenopausal patients will undergo pregnancy testing. Men will agree to not father a child while on protocol treatment. Men and women will practice effective birth control while receiving protocol treatment.
  • Participants may not be receiving any other Non-FDA approved study agents at the start of vaccination
  • Uncontrolled intercurrent illness including uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements.
  • Autoimmune or inflammatory disorders requiring active treatment with systemic steroids or immunosuppressive therapy limited to the following:

    • GI Disorders: (including inflammatory bowel disease [e.g., ulcerative colitis, Crohn's disease]
    • Systemic lupus erythematosus
    • Wegener's syndrome [granulomatosis with polyangiitis]
    • Myasthenia gravis
    • Graves' disease
    • Rheumatoid arthritis
    • Hypophysitis
    • Uveitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679650


Contacts
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Contact: Jacalyn Rosenblatt, MD 617-667-5982 jrosenb1@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Emma Logan, BSN    617-667-5984    eklogan@bidmc.harvard.edu   
Principal Investigator: Jacalyn Rosenblatt, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Robert J Soiffer, MD       Robert_soiffer@dfci.harvard.edu   
Principal Investigator: Robert J Soiffer, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jacalyn Rosenblatt, MD Beth Israel Deaconess Medical Center

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Responsible Party: Jacalyn Rosenblatt, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03679650    
Other Study ID Numbers: 18-202
1P50CA206963-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jacalyn Rosenblatt, MD, Dana-Farber Cancer Institute:
AML
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Decitabine
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors