A Phase I Clinical Trial of Dendritic Cell/AML Fusion Cell Vaccine Alone and in Conjunction With Decitabine Following Allogeneic Transplantation in AML Patients

Who is this study for? Patients with acute myelogenous leukemia
What treatments are being studied? Decitabine+DC/AML fusion cells
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Jacalyn Rosenblatt, MD
jrosenb1@bidmc.harvard.edu
617-667-5982
Time Frame
Start Date: 2018-10-11
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 45
Treatments
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
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
Related Therapeutic Areas
Sponsors
Collaborators: Dana-Farber Cancer Institute, National Cancer Institute (NCI)
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov