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Adult Acute Myeloid Leukemia in RemissionPhase 1NCT01842139

Vaccine Therapy and Basiliximab in Treating Patients With Acute Myeloid Leukemia in Complete Remission

A Phase 1 study testing basiliximab, WT1 126-134 peptide vaccine and Montanide ISA 51 VG in people with Adult Acute Myeloid Leukemia in Remission and Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, run by University of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized phase I trial studies the side effects and best way to give vaccine therapy together with basiliximab in treating patients with acute myeloid leukemia (AML) in complete remission. Vaccines made from the WT1 peptide may help the body build an effective immune response to kill cancer cells. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
basiliximab, WT1 126-134 peptide vaccine and Montanide ISA 51 VG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
5 Dec 2011to Mar 2018
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with Hematological malignancies, including AML, MDS, CML in blast phase and other conditions at the investigator's discretion.
  • Bone marrow biopsy-confirmed CR or CRi, more than CR1 is allowed, such as CR2 or CR3. The enrollee is deemed not a candidate for stem cell transplant due to advanced age or co-morbidities; or the enrollee does not have donor available; or enrollee refuses stem cell transplant due to personal belief; or stem cell transplant is not current standard of care. Patients who are post stem cell transplant in CR or CRi are allowed if they are off immunosuppression,and not treated with systematic steroid for GVHD
  • Karnofsky performance status index > or = 80%
  • Written informed consent
  • Absolute neutrophil count > or = 500/μl
  • Platelet count >= 20,000/μl with transfusion
Show all 16Show fewer
  • Creatinine = or < 2 x upper limit of normal (ULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) = or < 5 x ULN
  • Bilirubin = or < 3 x ULN
  • Human leukocyte antigens (HLA) typing: patient must express HLA-A2
  • Age > 18 years and < 85 years
  • Electrocardiogram (EKG) without evidence of arrhythmia or changes that indicate acute ischemia
  • Pulse oximetry showing oxygen saturation of at least 90% on room air
  • No irreversible coagulopathy, international normalized ratio (INR) =< 2
  • No sign of tumor lysis syndrome, uric acid needs to be in normal range prior to treatment
  • Not in diabetic ketoacidosis (DKA), sickle cell crisis, and not having severe peripheral vascular disease on active anti-coagulation treatment

Who cannot join

  • Pregnant or nursing women; women who still have child-bearing potential must be tested for urinary or serum beta human chorionic gonadotropin (βHCG)
  • Biological or chemotherapy in the 4 weeks prior to the start of dosing
  • Patients with intrinsic immunosuppression, including seropositivity for human immunodeficiency virus (HIV) antibody; patients should be tested for HIV
  • Serious concurrent infection, including active tuberculosis, hepatitis B, or hepatitis C; patients should be tested for hepatitis B surface antigen and hepatitis C antibody; patients who are hepatitis C antibody (Ab) positive can be eligible if they are PCR negative
  • Active or history of confirmed autoimmune disease
  • Concurrent systemic corticosteroids (except physiologic replacement doses) or other immunosuppressive drugs (eg. cyclosporin A)
  • Active or history of autoimmune disease including but not limited to rheumatoid arthritis (rheumatoid factor [RF]-positive with current or recent flare), inflammatory bowel disease, systemic lupus erythematosus (clinical evidence with antinuclear antibody [ANA] 1:80 or greater), ankylosing spondylitis, scleroderma, multiple sclerosis, autoimmune hemolytic anemia, and immune thrombocytopenic purpura; seropositivity alone will not be considered positive
  • Psychiatric illness that may make compliance to the clinical protocol unmanageable or may compromise the ability of the patient to give informed consent; patients with clinical evidence of dementia should have a competent designee participate in decision

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago

    Chicago, Illinois, 60637-1470

Other trials in United States

About this study

Official title: Randomized Phase I Study Combining Suppression of T Regulatory Cells With WT1 Vaccine Therapy for AML Patients in Complete Remission

This randomized phase I trial studies the side effects and best way to give vaccine therapy together with basiliximab in treating patients with acute myeloid leukemia (AML) in complete remission. Vaccines made from the WT1 peptide may help the body build an effective immune response to kill cancer cells. Montanide ISA 51 VG and poly-ICLC may enhance this response. Monoclonal antibodies, such as basiliximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether WT1 126-134 peptide vaccine with Montanide ISA 51 VG is more effective than with poly-ICLC when given together with basiliximab in treating AML

Read the detailed description

PRIMARY OBJECTIVES:

  1. To examine the immunogenicity of WT1 peptide (WT1 126-134 peptide vaccine) emulsified in Montanide (Montanide ISA 51 VG) in elderly patients with AML.

II. To determine whether toll-like receptor 3 (TLR3) agonist (poly-L-lysine and carboxymethyl cellulose [poly ICLC]) could be a potent immunologic adjuvant, and increases the frequencies of WT1-specific T cells following vaccination.

III. To determine whether depletion of regulatory T cells occurs upon administration of the anti-cluster of differentiation (CD)25 monoclonal antibody Basiliximab, and whether this is associated with increased frequencies of WT1-specific T cells following vaccination.

IV. To assess whether WT1 vaccination +/- TLR3 agonist (poly ICLC) combined with Basiliximab results in decreased levels of WT1 transcripts in peripheral blood cells compared to WT1 vaccination +/- TLR3 as measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR).

SECONDARY OBJECTIVES:

  1. To examine the safety and gain preliminary information on efficacy of WT1 peptide vaccination +/- TLR3 agonist (poly ICLC) combined with Basiliximab.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive WT1 126-134 peptide vaccine emulsified in Montanide ISA 51 VG subcutaneously (SC) on day 0 and then once every 2 weeks.

ARM B: Patients receive WT1 126-134 peptide vaccine emulsified in poly-ICLC SC on day 0 and then once every 2 weeks.

ARM C: Patients assigned to Arm C receive basiliximab intravenously (IV) over 30 minutes on day -7 and WT1 126-134 peptide vaccine as in Arm A or Arm B, whichever had a superior cellular immune response.

In all arms, treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients may then receive 6 additional monthly vaccinations.

After completion of study treatment, patients are followed up for up to 2 years.

Being tested
basiliximab, WT1 126-134 peptide vaccine, Montanide ISA 51 VG, poly ICLC, laboratory biomarker analysis
Medical subject headings
Congenital Abnormalities

What participants receive

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

  • basiliximabBiological

    Also called SDZ-CHI-621, Simulect

    Given IV

  • WT1 126-134 peptide vaccineBiological

    Given SC

  • Montanide ISA 51 VGDrug

    Given SC

  • poly ICLCDrug

    Also called Hiltonol, poly I:poly C with poly-1-lysine stabilizer, Polyinosinic-Polycytidylic Acid Stabilized with Polylysine and Carboxymethylcellulose, stabilized polyriboinosinic/polyribocytidylic acid

    Given SC

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01842139
Study groupRoleWhat they receive
Arm A (vaccine with Montanide)ExperimentalPatients receive WT1 126-134 peptide vaccine emulsified in Montanide ISA 51 VG SC on day 0 and then once every 2 weeks.
Receives: Biological: WT1 126-134 peptide vaccine; Drug: Montanide ISA 51 VG; Other: laboratory biomarker analysis
Arm B (vaccine with poly-ICLC)ExperimentalPatients receive WT1 126-134 peptide vaccine in poly-ICLC SC on day 0 and then once every 2 weeks.
Receives: Biological: WT1 126-134 peptide vaccine; Drug: poly ICLC; Other: laboratory biomarker analysis
Arm C (vaccine therapy, monoclonal antibody)ExperimentalPatients assigned to Arm C receive basiliximab IV over 30 minutes on day -7 and WT1 126-134 peptide vaccine as in Arm A or Arm B, whichever had a superior cellular immune response.
Receives: Biological: basiliximab; Biological: WT1 126-134 peptide vaccine; Drug: Montanide ISA 51 VG; Drug: poly ICLC; Other: laboratory biomarker analysis

What is being measured

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

  1. Comparison of peptide specific immunologic response between regimens

    Evaluated by flow cytometry and using IFN-gamma ELISPOT as the primary measures. Compared using a two-sample t test.

    Measured: Over 9 months

  2. Comparison of regulatory T cells (Treg) number changes between regimens

    Evaluated by flow cytometry and using interferon (IFN)-gamma Enzyme-linked immunosorbent spot (ELISPOT) as the primary measures. Compared using a two-sample test. The Treg cell counts and percentage by flow cytometry, the FoxP3 expression by qRT-PCR, and the peptide specific CD8+cell level by ELISPOT will be measured continuously prior to basiliximab and WT1 126-134 peptide vaccine and after basiliximab and/or WT! 126-134 peptide vaccine.

    Measured: 9 months

Secondary outcomes (2)

  1. Molecular response in terms of WT1 expression

    Measured: Every 12 weeks for 1 year after stopping treatment

  2. Relapse-free survival

    Measured: Every 12 weeks for 1 year after stopping treatment

Timeline

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

  1. First posted29 Apr 2013 (estimated)
  2. Study start5 Dec 2011
  3. Primary completion2 Feb 2015
  4. Study completionMar 2018

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01842139
Sponsor's protocol ID
11-0545
Other IDs
NCI-2011-03588
Status last verified
Mar 2018
First submitted
3 Jul 2012
Last updated
9 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • Liu H, Zha Y, Choudhury N, Malnassy G, Fulton N, Green M, Park JH, Nakamura Y, Larson RA, Salazar AM, Odenike O, Gajewski TF, Stock W. WT1 peptide vaccine in Montanide in contrast to poly ICLC, is able to induce WT1-specific immune response with TCR clonal enrichment in myeloid leukemia. Exp Hematol Oncol. 2018 Jan 11;7:1. doi: 10.1186/s40164-018-0093-x. eCollection 2018.

    PubMed 29344432

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing basiliximab, WT1 126-134 peptide vaccine and Montanide ISA 51 VG in people with Adult Acute Myeloid Leukemia in Remission and Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, run by University of Chicago 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 16 inclusion and 8 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: finished, as of the sponsor's last update on 9 Mar 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Comparison of peptide specific immunologic response between regimens (time frame: Over 9 months). The study lists 2 primary outcomes in all. 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 NCT01842139, which also lists 1 linked publication.

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 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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