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Myeloid Leukemia, ChronicPhase 1/2NCT02543749

DC Vaccination in CML

A Phase 1/2 study testing DC vaccine in people with Myeloid Leukemia, Chronic, run by Charite University, Berlin, Germany at 2 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim of this phase I/II trial is induction of anti leukemic T cell immunity in a clinical situation of "minimal residual disease". This might be a strategy to immunologically eradicate the residual leukemia cells. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Myeloid Leukemia, Chronic
What is being tested?
DC vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
2 sitesGermany
Study dates
Jul 2014to Jul 2022
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 bcr/abl-positive CML in stable cytogenetic / molecular remission after at least 18 months therapy with tyrosine kinase Inhibitors (TKI). The following groups of patients will be included:
  • complete cytogenetic remission (CCyR), but stable detection of bcr/abl-transcript on qPCR (at least on two different time points over a period of at least 6 months). A stable molecular remission is assumed, if the difference between the qPCR values does not exceed a factor 5 (< 0,5log).
  • No CCyR, but qPCR for bcr/abl transcript < 10% (= MCyR (Major cytogenetic Response)) after at least 24 months on 2nd generation TKI therapy.
  • Treatment with a TKI inhibitor and an additional anti leukemic drug is no exclusion criterion.
  • Age 18-80 years
  • Performance status of 0 or 1 according to WHO index or Karnofsky index >70 %
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  • Life expectancy > 18 months
  • Hematological function should be at least partially conserved (platelets count >50.000/ μl, Hb > 8g/dl)
  • written informed consent
  • No breast feeding
  • if of childbearing potential, negative pregnancy test (serum/urine ß- HCG ( human chorionic gonadotropin )) and willingness to use highly effective contraceptive methods (Pearl Index <1, e.g.: birth control pill, loop, hormone implant, transdermal hormone patch, a combination of two barrier methods [condom and vaginal diaphragm] sterilisation or sexual abstinence) for the study duration and thereafter as long as under treatment with antileukemic drugs

Who cannot join

  • Clinically relevant autoimmune disorders
  • Immunodeficiency syndromes
  • Known allergy to GM-CSF (granulocyte macrophage colony-stimulating factor), TNF-α (Tumor necrosis factor Alpha) , IL-4 (interleukine 4) or KLH (keyhole limpet hemocyanin)
  • Pregnancy (absence confirmed by serum/urine ß-HCG) or breastfeeding
  • Women of childbearing age without highly effective contraception
  • Active infectious disease requiring treatment
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  • Continuous therapy with corticosteroids or other immunosuppressive drugs
  • Severe psychiatric disorders
  • Organ dysfunction:
  • Thrombin Time / Partial Thromboplastin Time > 1,5 x upper normal limit
  • creatinine > 2,0 mg/ml
  • Bilirubin > 3,0 mg/ml, ALAT/ASAT (Alanine aminotransferase/ aspartate aminotransferase) > 3x upper normal limit
  • pulmonary disfunction (dyspnea at rest or with minimal exertion)
  • clinically relevant coronary heart disease or ventricular arrhythmia, congestive heart failure > grade II NYHA (New York Heart Association)
  • Persons who are detained officially or legally to an official institute
  • Subjects for whom there is concern about compliance with the protocol procedures
  • Present History of substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) that could limit the subject's ability to comply with study procedures

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Charité - University Medicine Berlin

    Berlin, 13353

  • Klinikum Bremen Mitte

    Bremen, 28177

Other trials in Germany

About this study

Official title: Dendritic Cells as Autologous Vaccine in Patients With Chronic Myeloid Leukemia

The aim of this phase I/II trial is induction of anti leukemic T cell immunity in a clinical situation of "minimal residual disease". This might be a strategy to immunologically eradicate the residual leukemia cells. Patients to be included are chronic phase bcr/abl+ CML (chronic myeloid leukemia) patients in stable cytogenetic and/or molecular remission.

These patients can be included if they have:

Read more
  1. not achieved a CMR (complete molecular response) or
  2. achieved bcr/abl < 10% on qPCR (quantitative polymerase chain reaction) (=MCyR) (Major cytogenic Response), but less than a CCyR (complete cytogenic Response).

Autologous DC (Dendritic cells), generated under GMP (Good manufacturing conditions) conditions, are used as a vaccine. These DC constitutively express all putative tumor antigens. In order to ensure sufficient presentation of distinct CML-related antigens, particularly in good responders to TKIs, DC are additionally pulsed with peptides from bcr/abl, WT-1 (Wilms Tumor Protein) and proteinase-3. Monitoring of T cell reactivity against these peptides can then serve as surrogate marker for anti leukemic immunity induced by the vaccine. Vaccination is performed with 10^7 DC i.d. (intra dermal) in weeks 1, 3, 5, 8, 11, 14, 17, 20, 23 and 26. KLH (keyhole limpet hemocyanin) is used as an adjuvant for vaccine preparations in weeks 3, 5 and 8 (and 11).

Being tested
DC vaccine
Keywords
CML, DC vaccine
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

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

  • DC vaccineBiological

    Autologous DC pulsed with leukemia-associated peptides+adjuvant

Study groups in NCT02543749
Study groupRoleWhat they receive
DC vaccineExperimentalAutologous DC pulsed with leukemia-associated peptides+adjuvant. Ten vaccinations over 26 weeks with 10 x 106 freshly thawed DC Intradermal injections (1-2 ml volume)
Receives: Biological: DC vaccine

What is being measured

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

  1. DC toxicity Parameters using CTC (Common toxicity criteria)

    Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 (Treatment: long-term vaccination with peptide-pulsed autologous DC in patients with chronic phase CML who have persistent residual cytogenetic and/or molecular disease after at least 18 months therapy with a tyrosine kinase Inhibitor)

    Measured: 30 weeks

Secondary outcomes (5)

  1. Molecular/cytogenetic Response under vaccination as measured by qPCR for bcr/abl in % IS (International scale)

    Measured: 30 weeks

  2. T-cell Response: Antigen specific T-cell Response in % CD8+ T-cells for bcr/abl

    Measured: 30 weeks

  3. T-cell Response: Antigen specific T-cell Response in % CD4+ T-cells for bcr/abl

    Measured: 30 weeks

  4. T-cell Response: Antigen specific T-cell Response in % CD8+ T-cells for WT-1 (only in HLA-A2+ patients)

    Measured: 30 weeks

  5. T-cell Response: Antigen specific T-cell Response in % CD8+ T-cells for Proteinase 3 (only in HLA-A2+ patients)

    Measured: 30 weeks

Timeline

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

  1. First posted7 Sep 2015 (estimated)
  2. Study startJul 2014
  3. Primary completionJul 2022
  4. Study completionJul 2022

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02543749
Sponsor's protocol ID
CSTI571ADE60
Other IDs
2006-006962-41
Status last verified
Feb 2023
First submitted
25 Aug 2015
Last updated
9 Feb 2023
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DC vaccine in people with Myeloid Leukemia, Chronic, run by Charite University, Berlin, Germany at 2 sites in Germany.

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 11 inclusion and 17 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: stopped early, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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 was stopped early. Results are not available in the source record.

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?

DC toxicity Parameters using CTC (Common toxicity criteria) (time frame: 30 weeks). 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 NCT02543749.

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 Feb 2023.

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