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DC/AML Fusion Cell Vaccine vs Observation in Patients Who Achieve a Chemotherapy-induced Remission

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: NCT03059485
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : November 1, 2019
Sponsor:
Collaborator:
Celgene
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)


Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Biological: DC/AML Fusion Vaccine Other: Observation Phase 2

Detailed Description:

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

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

The FDA (the U.S. Food and Drug Administration) has not approved durvalumab as a treatment for AML.

In this research study, the investigators are determining if the DC/AML vaccine can be used safely in subjects with acute leukemia after finishing chemotherapy, and whether the DC/AML vaccine is capable of producing immune responses against leukemia alone. 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 Dendritic Cell Fusion 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Clinical Trial of Dendritic Cell/AML Fusion Cell Vaccine Versus Observation in Patients Who Achieve a Chemotherapy-induced Remission
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2024


Arm Intervention/treatment
Experimental: DC/AML Vaccine
- Patients will be vaccinated with DC/AML Fusion Vaccine
Biological: DC/AML Fusion Vaccine
The Dendritic Cell Fusion Vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells

Other: Observation
Traditional care provided by the hospital.

Experimental: Observation
- Patients will be monitored with routine labs and bone marrow biopsies
Other: Observation
Traditional care provided by the hospital.




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 years ]
  2. Assessing Toxicity using CTCAE version 4.03 [ Time Frame: 2 years ]


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

Step 1: Eligibility Criteria for Tumor Collection

Inclusion Criteria

  • Patients must have AML at initial diagnosis or at first relapse
  • Patients must be ≥ 55 years old
  • ECOG performance status ≤2 (Appendix A)
  • Patients must have normal organ and marrow function as defined below:

total bilirubin ≤ 2.0 mg/dL AST(SGOT)/ALT(SGPT) ≤3 × institutional upper limit of normal creatinine ≤ 2.0 mg/dl

  • 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.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

-Active or prior documented autoimmune or inflammatory disorders including but not limited to the following:

--GI Disorders: (including inflammatory bowel disease [eg, ulcerative colitis, Crohn's disease], diverticulitis (with the exception of a prior episode that has resolved), celiac disease, or other serious gastrointestinal chronic conditions associated with diarrhea.

  • Systemic lupus erythematosus
  • Wegener's syndrome [granulomatosis with polyangiitis]
  • Myasthenia gravis
  • Graves' disease
  • Rheumatoid arthritis
  • Hypophysitis
  • Uveitis

The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment..

  • Because of compromised cellular immunity, patients who have a Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
  • Patients must not have significant cardiac disease characterized by symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia
  • 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.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: non-invasive cancer (such as, any in situ cancers) and basal cell or squamous cell carcinoma of the skin.
  • Prior allogeneic transplant

Step 2: Eligibility Criteria Prior to Randomization

Inclusion Criteria

  • Patients must have obtained a complete remission with chemotherapy defined by the absence of circulating blasts, and less than 5% blasts on bone marrow examination following hematopoietic recovery
  • Resolution of all chemotherapy related grade III-IV toxicity as per CTC criteria 4.0
  • Laboratories:

Absolute Neutrophil Count >1,000/uL Platelets > 50,000/uL Bilirubin < 2.0 mg/dL Creatinine <2.0 mg/dL AST/ALT < 3.0 x ULN

- 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.

Exclusion Criteria

  • Patients must not have 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, with their treating physician, choose to proceed with an allogeneic transplant at the time of remission will not be eligible for randomization
  • Active or prior documented autoimmune or inflammatory disorders including but not limited to the following:

    • GI Disorders: (including inflammatory bowel disease [eg, ulcerative colitis, Crohn's disease], diverticulitis (with the exception of a prior episode that has resolved), celiac disease, or other serious gastrointestinal chronic conditions associated with diarrhea.

      • Systemic lupus erythematosus
      • Wegener's syndrome [granulomatosis with polyangiitis]
      • Myasthenia gravis
      • Graves' disease
      • Rheumatoid arthritis
      • Hypophysitis
      • Uveitis

The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment.

  • Current or prior use of immunosuppressive medication within 14 days prior to first dose of vaccine. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (eg. intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10mg/day of prednisone or equivalent
  • Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
  • History of hypersensitivity to durvalumab or any excipient
  • Receipt of live attenuated vaccination within 30 days prior the first vaccine
  • Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control from starting vaccine, including dosing interruptions through 90 days after receipt of the last vaccine. Refrain from egg cell donation during vaccination and for at least 90 days after the last vaccine.
  • Male subjects who are not employing an effective method of birth control from starting vaccine, including dosing interruptions through 90 days after receipt of the last vaccine. Refrain from sperm donation during vaccination and for at least 90 days after the last vaccine.

Step 3: Eligibility Criteria Prior to Treatment or Observation

  • Resolution of all chemotherapy related grade III-IV toxicity as per CTC criteria 4.0
  • Laboratories:

WBC > 2.0 X 103/uL Platelets > 50,000/uL Bilirubin < 2.0 mg/dL Creatinine <2.0 mg/dL AST/ALT < 3.0 x ULN

- At least 2 doses of fusion vaccine were produced (Arm A only)


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): NCT03059485


Contacts
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Contact: Jacalyn Rosenblatt, MD 617-667-9920 jrosenb1@bidmc.harvard.edu
Contact: Emma K Logan, BSN 617-667-5984 eklogan@bidmc.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02214
Contact: Amir Fathi, MD         
Principal Investigator: Amir Fathi, MD         
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jacalyn Rosenblatt, MD    617-667-9920      
Principal Investigator: Jacalyn Rosenblatt, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Richard Stone, MD    617-632-2214      
Principal Investigator: Richard Stone, MD         
United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Contact: Aric Hall, MD    608-265-1700      
Sponsors and Collaborators
Dana-Farber Cancer Institute
Celgene
Investigators
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Principal Investigator: Jacalyn Rosenblatt, MD Beth Israel Deaconess Medical Center

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Responsible Party: Jacalyn Rosenblatt, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03059485    
Other Study ID Numbers: 16-593
First Posted: February 23, 2017    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:
Leukemia
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs