AzTrials
AzTrials

Acute Myeloid Leukemia (AML)Phase 1/2NCT01373515

Leukemic Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia

A Phase 1/2 study testing DCP-001 in people with Acute Myeloid Leukemia (AML) and Leukemic Dendritic Cell Vaccination, run by Mendus at 1 site in Netherlands.

Completed

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

Official record
Search all trials

Trial summary

This is an open label phase 1 feasibility and safety dose escalation study. The main objective is to evaluate the safety of DCP-001 intradermal vaccination in patients with AML. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
DCP-001
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteNetherlands
Study dates
Apr 2011to May 2013
Phase
Phase 1/2
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with AML, in second complete remission of AML (all FAB-subclasses), not eligible for additional intensification therapies e.g. allogeneic (allo) PSCT [independent of age]; OR
  • Patients with relapse (smouldering) AML not eligible for additional intensification therapies e.g. alloPSCT; OR
  • Patients with de novo (smouldering) AML not eligible for intensive treatment according to current HOVON trials.
  • Patients >65 years of age with de novo AML in first CR and off protocol of current HOVON trials.
  • WHO performance of 0, 1, or 2.
  • Male or female patients at least 18 years of age and <80 years by date of enrolment.
Show all 9Show fewer
  • Patients not treated within current HOVON or other AML trials.
  • Ability and willingness to give informed consent.
  • HLA-A2.1 positive patients (only for cohort 4).

Who cannot join

  • Uncontrolled active infection.
  • Previous immunotherapy in last 3 months (except for anti-CD33 targeted therapy).
  • Previous allogeneic PSCT.
  • Inadequate bone marrow function: absolute neutrophile count (ANC) < 0.5x10E9/L, or platelet count < 20x10E9/L or active bleeding with platelet count > 20x10E9/L.
  • Inadequate liver function, defined as:
  • Serum (total) bilirubin > 1.5 x the upper limit of normal (ULN)
Show all 19Show fewer
  • AST/SGOT or ALT/SGPT > 2.5 x ULN
  • Alkaline phosphatase levels > 2.5 times the ULN at baseline.
  • Inadequate renal function, defined as:
  • Serum creatinine > 1.5 x ULN
  • Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
  • Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start.
  • Women of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly).
  • Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment.
  • Minor surgical procedures, within 24 hours prior to the first study treatment.
  • Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident (CVA) / stroke within ≤ 6 months prior to the first study treatment, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF), or serious cardiac arrhythmia requiring medication.
  • Known hypersensitivity to any of the study drugs or excipients.
  • Evidence of an other medical condition (such as psychiatric illness, physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.
  • Eligibility for the HOVON-93 study (intensification program ± allogeneic stem cell transplant).

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • VU University Medical Center

    Amsterdam

Other trials in Netherlands

About this study

Official title: Phase 1 Study of Leukemic Dendritic Cell Vaccination in Patients With Acute Myeloid Leukemia

This is an open label phase 1 feasibility and safety dose escalation study. The main objective is to evaluate the safety of DCP-001 intradermal vaccination in patients with AML.

Read the detailed description

DCPrime is testing an allogeneic (non-self cells, standardised product) DC-based immunotherapy in cancer patients. The technology consists of sustainable dendritic progenitor cells (named "DCOne™") and a proprietary method to expand these and to create functional mature dendritic cells (DCP-001).

AML is a fast growing form of leukemia that particularly in the elderly (>60) is life threatening. As age is an important factor in determining the success of AML treatment, overall, AML has a bad prognosis as only 24% of the patients are alive 5 years after diagnosis.

Without treatment AML is fatal, usually within months. Chemotherapy can cure patients and prolong survival in responders; however, chemotherapy is also quite toxic and can cause substantial morbidity and mortality. The most commonly prescribed first line therapy for patients with AML is a combination of an anthracycline and cytarabine; in the Western world the anthracycline is either daunorubicin or idarubicin. Post remission therapy (consolidation therapy) is usually given.

There is therefore substantial medical need for new treatment modalities. One of the major difficulties regarding development of new agents is that relatively low response rates and toxicity issues have been in the way of approval of new agents. Immunotherapy, in particular with the therapeutic vaccines, is expected to have potential in prevention of recurrence of disease after cytoreductive therapy. Any drug that could prevent or reduce minimal residual disease in the population is likely to meet a strong medical need for this population of high risk patients.

In this phase 1 trial consecutive eligible patients will be treated until 12 patients have completed the study. Patients will be started with the vaccination program within 2 months after having achieved complete remission or in patients who have stable disease over at least a 2 month period.

The first cohort (n=3) will receive 4 bi-weekly vaccinations of 1x10E7 DCP-001, the second cohort (n=3) will receive 4 bi-weekly vaccinations of 2.5x10E7 DCP-001, and the last cohort (n=3) will receive 4 bi-weekly vaccinations of 5x10E7 DCP-001. The Dose Limiting Toxicity (DTL) is defined as non-hematological toxicity of ≥ 3 according to common toxicity criteria v3.0. The 4th cohort (matched for HLA-A2) will receive 4 vaccinations of the highest dose (5x10E7 DCP-001) or, in case this turned out to be toxic (as determined by the vaccination profile of cohort 1, 2 and 3), this group will receive the Maximum Tolerated Dose (MTD).

DCP-001 vaccine is presented as a direct injectable sterile cell suspension consisting of irradiated mature dendritic cells in cryopreservation solution packed in vials. The vaccine will be administered intradermally.

Being tested
DCP-001
Keywords
DCOne, DCP-001, Second complete remission of AML, Relapse AML
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.

  • DCP-001Biological

    4 bi-weekly vaccinations

Study groups in NCT01373515
Study groupRoleWhat they receive
Cohort 1; 1x10E7 DCP-001Experimentaln=3; patients receiving 4 bi-weekly vaccinations of 1x10E7 DCP-001.
Receives: Biological: DCP-001
Cohort 2; 2.5x10E7 DCP-001Experimentaln=3; patients receiving 4 bi-weekly vaccinations of 2.5x10E7 DCP-001.
Receives: Biological: DCP-001
Cohort 3; 5x10E7 DCP-001Experimentaln=3; patients receiving 4 bi-weekly vaccinations of 5x10E7 DCP-001.
Receives: Biological: DCP-001
Cohort 4; 5x10E7 DCP-001Experimentaln=3; patients, matched for HLA-A2, receiving 4 bi-weekly vaccinations of 5x10E7 DCP-001. Or, in case this turned out toxic, this group will receive the Maximum Tolerated Dose.
Receives: Biological: DCP-001

What is being measured

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

  1. Safety/Feasibility of DCP-001 vaccination

    The primary endpoint of this study will be the safety and feasibility of DCP-001 vaccination in AML patients. Safety will be assessed by means of laboratory evalulations, lhysical examination, vital sign assessments and adverse events recording. Clinical efficacy is assessed by the presence of leukemic cells in blood and bonemarrow and physical examination at baseline, during and after vaccination

    Measured: three months and follow up after study completion

Secondary outcomes (1)

  1. Immunological responses induced by DCP-001 vaccination

    The secondary endpoint of this study will be establishment of immunological responses induced by DCP-001 vaccination.

    Measured: 3 months

Timeline

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

  1. First posted15 Jun 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionFeb 2013
  4. Study completionMay 2013

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 1/2
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01373515
Sponsor's protocol ID
DCOne-1
Status last verified
Oct 2022
First submitted
30 May 2011
Last updated
10 Oct 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DCP-001 in people with Acute Myeloid Leukemia (AML) and Leukemic Dendritic Cell Vaccination, run by Mendus at 1 site in Netherlands.

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 9 inclusion and 19 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 10 Oct 2022. 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 Netherlands. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Safety/Feasibility of DCP-001 vaccination (time frame: three months and follow up after study completion). 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 NCT01373515.

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 10 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in