Clinical Trial - NCT03059485

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

Recruiting

Sponsor: Dana-Farber Cancer Institute

Collaborators: Celgene

Information provided by (Responsible party): Principal Investigator Dana-Farber Cancer Institute Jacalyn Rosenblatt, MD Jacalyn Rosenblatt, MD

ClinicalTrials.gov Identifier: NCT03059485

Protocol Info

Short Description: DC/AML FUSION CELL VACCINE + DURVALUMAB IN AML
Long Description: A Randomized Phase II Clinical Trial of Dendritic Cell/AML Fusion cell vaccine versus DC/AML fusion cell vaccine in conjunction with Durvalumab, versus observation in patients who achieve a chemotherapy-induced remission
MGH Status: Open
Sponsor: DF/HCC
Disease Program: Leukemia

Next Steps


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Purpose

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 Title Intervention Phase
Acute Myelogenous Leukemia DC/AML Fusion Vaccine Observation Phase 2
Study Type Interventional
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

Primary Outcome Measures

Progression Free Survival [Time Frame: 2 years] [Designated as safety issue: ]


Secondary Outcome Measures

Overall Survival [Time Frame: 2 years] [Designated as safety issue: ]

Assessing Toxicity using CTCAE version 4.03 [Time Frame: 2 years] [Designated as safety issue: ]

Estimated Enrollment: 75
Study Start Date: June 2017
Estimated Study Completion Date: September 2024
Estimated Primary Completion Date: September 2021
Arms Assigned Interventions

Experimental:DC/AML Vaccine

- Patients will be vaccinated with DC/AML Fusion Vaccine
Other:Observation
Traditional care provided by the hospital.

Experimental:Observation

- Patients will be monitored with routine labs and bone marrow biopsies

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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
  • Patient required no more than 2 cycles of chemotherapy or 4 cycles of a hypomethylating agent (alone or in conjunction with venetoclax) to achieve remission.
  • 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03059485

Locations

  • United States, Georgia
    • Emory Winship Cancer Institute Atlanta, Georgia, United States, 30033
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02214
    • Beth Israel Deaconess Medical Center Boston, Massachusetts, United States, 02215
    • Dana Farber Cancer Institute Boston, Massachusetts, United States, 02215
  • United States, Wisconsin
    • University of Wisconsin Carbone Cancer Center Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Dana-Farber Cancer Institute

Celgene

More Information

No publications provided

Responsible Party: Principal Investigator Dana-Farber Cancer Institute Jacalyn Rosenblatt, MD Jacalyn Rosenblatt, MD
ClinicalTrials.gov Identifier: NCT03059485
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Dana-Farber Cancer Institute:

Leukemia

Additional relevant MeSH terms:

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Vaccines

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on April 09, 2020