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Acute Myelogenous LeukemiaPhase 1AMLNCT01483274

Decitabine and Vaccine Therapy for Patients With Relapsed AML Following Allogeneic Stem Cell Transplantation

A Phase 1 study testing Vaccine in people with Acute Myelogenous Leukemia, run by University of Louisville at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Patients with Acute Myelogenous Leukemia (AML) who relapse after an allogeneic stem cell transplant cell receive decitabine to up regulate cancer antigen expression, followed by a donor lymphocyte infusion and an autologous dendritic cell (DC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Myelogenous Leukemia
What is being tested?
Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Mar 2015to Jun 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent after discussion of alternative therapies.
  • The first six patients be18 to 65 years old. Patients # 7-10 will range in age from 2 - 65 years.
  • Histologically or cytogenetically confirmed diagnosis of acute myelogenous leukemia prior to allogeneic SCT, with the following risk factors:
  • > second complete response, or in relapse, at the time of transplant
  • monosomy 5 or 7
  • the presence of a high FLT3/ITD allelic ratio
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  • patients with detectable minimal residual disease (MRD) post-transplant
  • < 0.5% positive for recipient leukemia cells by flow cytometry
  • Patient is at least three months post-transplant.
  • Patients must be off systemic immunosuppression for at least two weeks prior to the start of therapy on the study.
  • ECOG performance status 0-2, Lansky performance status >70 (see Appendix 1).
  • Hematologic Function: ANC: ≥ 500; Platelet count: ≥ 75.
  • Renal Function:
  • Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 OR a serum creatinine based on age/gender using the Schwartz formula:
  • Cardiac Function: Patient must have normal cardiac function documented within two weeks before starting of a treatment cycle 1 by:
  • Ejection fraction (> 55%) documented by echocardiogram or fractional shortening (≥ 28%) documented by echocardiogram.
  • Liver Function: Total bilirubin ≤ 1.5 x normal for age, and ALT (SGPT) and AST (SGOT) ≤ 3 x normal for age.
  • Room air pulse oximetry > 94%.
  • Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of enrollment.
  • Male and female patients must agree to use a medically acceptable barrier and/or chemical contraceptive method during the study and for a minimum of 3 months after the last dose of chemotherapy on this study.
  • Subjects must be > 3 months and < 12 months post-SCT at the time of the first vaccination.
  • Donor chimerism must be > 90%, assist at least two weeks prior to beginning treatment
  • Subjects must be at least 30 days post-transplant to enroll on the study and to undergo apheresis, and must be at least three months post-transplant to begin therapy with DAC/vaccine.
  • Stem cell donor source may be related or unrelated donor cord blood, related or unrelated donor bone marrow, and related or unrelated donor peripheral blood stem cell product. Donors may be no more than two HLA (A, B, C, DR, DQ) antigen mismatched with the recipient.

Who cannot join

  • Patient has a history of autoimmune disease, specifically inflammatory bowel disease, systemic lupus erythematosis, or rheumatoid arthritis.
  • Patient has a known systemic hypersensitivity to DAC, imiquimod, or any vaccine component.
  • Patient has evidence of recurrent leukemia.
  • Patient is receiving systemic corticosteroids or other immunosuppression.
  • Persistent clinically significant toxicity from prior anticancer therapy that is > Grade 2 (NCI CTCAE v3.0).
  • Pregnant or lactating females are excluded.
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  • Other active systemic malignancy other than leukemia expected to require therapy within 4 months.
  • Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
  • Any condition which, in the opinion of the investigator, would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
  • Patients with a positive result for any of the following diagnostic tests: Hep B Ag, Hep B Core Ab, Hep C Ab, HIV-1 Ab, HIV-2 Ab, HTLV-1 Ab, HTLV-2 Ab, RPR.
  • Received any investigational new drug within 30 days prior to the first dose of vaccine , or are scheduled to receive an investigational new during the course of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Louisville

    Louisville, Kentucky, 40202

Other trials in United States

About this study

Official title: Pharmacologic Upregulation of Cancer Testis Antigens Followed by Vaccine Therapy for Patients With Relapsed Acute Myelogenous Leukemia (AML) Following Allogeneic Stem Cell Transplantation

Patients with Acute Myelogenous Leukemia (AML) who relapse after an allogeneic stem cell transplant cell receive decitabine to up regulate cancer antigen expression, followed by a donor lymphocyte infusion and an autologous dendritic cell (DC). Vaccine Dendritic cells are pulsed with overlapping peptides derived from MAGE-A1, MAGE-A3, and NY-ESO-1.

Read the detailed description

For vaccine production, mature DC will be pulsed with overlapping peptides mixes derived from full-length NY-ESO-1, MAGE-A1, and MAGE-A3.

Being tested
Vaccine
Keywords
AML, vaccine
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VaccineBiological

    Also called DAC, Dendritic cells vaccine

    Decitabine followed by donor lymphocyte infusing and Dendritic cells pulsed with MAGE-A1, MAGE-A3, and NEY-ESO-1 vaccine

Study groups in NCT01483274
Study groupRoleWhat they receive
SafetyExperimentalDecitabine and donor lymphocyte infused dendritic cell (DC).
Receives: Biological: Vaccine
VaccineActive comparatorDecitabine and Dendritic cell (DC) pulsed with MAGE-A1, MAGE-A3, NY-ESO-1 Peptides
Receives: Biological: Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tolerance of study treatment

    Tolerance to DAC, at least 50% dosing, and 3 of the 4 planned vaccinations during the first two cycles

    Measured: 4 years

Secondary outcomes (2)

  1. Disease Response

    Assessment of Bone Marrow aspiration to check for complete or partial remission, stable disease, and disease progression by bone marrow draws at week 6 and week 12.

    Measured: 4 years

  2. Immune Response

    Assessment of post-vaccination T cell responses to MAGE-A1, MAGE-A3, and NY-ESO-1 by immunoassay

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2011 (estimated)
  2. Study startMar 2015
  3. Primary completionJun 2015
  4. Study completionJun 2015

Why it stopped: Adult patient population barriers.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01483274
Sponsor's protocol ID
13.0376
Acronym
AML
Status last verified
May 2017
First submitted
3 Nov 2011
Last updated
9 May 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vaccine in people with Acute Myelogenous Leukemia, run by University of Louisville at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerance of study treatment (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01483274.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.

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