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Acute Myeloid LeukemiaPhase 1CYCLE-1NCT04167696

Study in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients to Determine the Recommended Dose of CYAD-02

A Phase 1 study testing CYAD-02, ENDOXAN and Fludara in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Celyad Oncology SA at 5 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

An open-label, phase I, multi-center study to determine in relapsed/refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients the recommended dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a potential CYAD-02 consolidation cycle for non-progressive… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CYAD-02, ENDOXAN and Fludara
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
5 sitesin 2 countries
Study dates
25 Nov 2019to Feb 2035
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient must not be eligible for standard of care therapy and have one of the following hematological malignancy:
  • A confirmed relapsed or refractory acute AML (i.e. ≥ 5% blasts in bone marrow or in peripheral blood) with revised European LeukemiaNet (ELN) 2017 risk stratification for favorable, intermediate or adverse groups, after at least one prior therapy defined as either
  • Recurrence of disease after a first complete remission and not eligible for a second course of induction therapy, or
  • Recurrence of disease after a second complete remission, or
  • Failure to achieve a Complete Response after induction chemotherapy.
  • A confirmed MDS as defined by revised International Prognostic Scoring System criteria for intermediate, high-risk or very high-risk disease or MDS with Tumor Protein 53 mutation as detected by next-generation sequencing, after failure of prior treatment with at least 4 cycles of azacitidine or decitabine defined as:
Show all 16Show fewer
  • No response to treatment,
  • Loss of response at any time point, or
  • Intolerance to therapy.
  • The patient must have evaluable disease as defined by:
  • Revised Recommendations of the International Working Group (IWG) for Diagnosis, Standardization of Response Criteria for AML patients,
  • IWG 2006 Uniform Response Criteria for patients with MDS.
  • The absolute peripheral blast count should be < 15,000/L.
  • The patient must have adequate hepatic and renal functions, as assessed by standard laboratory criteria.
  • The patient must have a left ventricular ejection fraction of ≥ 40 %, as determined by echocardiography or a multigated acquisition scan.
  • The patient must have a Forced Expiratory Volume (FEV) in the first second /Forced Vital Capacity = 0.7 with FEV-1 at 50 % predicted (GOLD 1 or 2 severity) as determined by spirometry

Who cannot join

  • Patients with a confirmed or history of tumor involvement in the central nervous system
  • Patients who have received any cancer therapy with therapeutic intent (investigational agent or not)
  • Patients with any positive serology test results at baseline
  • Patients who plan to receive, are concurrently receiving or have received any investigational agent within 3 weeks before the planned day for the first CYAD-02 infusion
  • Patients with uncontrolled intercurrent illness or serious uncontrolled medical disorder
  • Patients with significant coagulation disorder or who are receiving treatment with warfarin derivatives, heparin or direct oral anticoagulants
  • Patients who have active infections
  • Patients with documented history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis and/or active or acute exacerbation of chronic obstructive pulmonary disease

Trial locations and contacts

5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Frederic LEHMANN, MD, PhD contact

003210394100

flehmann@celyad.com

5 sites in 2 countries

Belgium3 sites, 3 recruiting

  • Uz Leuven

    Leuven, 3000

    Johan MAERTENS, MD, 003216 34 68 80, johan.maertens@uzleuven.be

    Johan MAERTENS

    Recruiting

  • Chu Liege

    Liège, 4000

    YVES BEGUIN, MD, 0032 4 242 52 00, yves.beguin@chuliege.be

    YVES BEGUIN, MD

    Recruiting

  • AZ DELTA

    Roeselare, 8800

    Dries DEEREN, MD, 003251 23 73 22, Dries.Deeren@azdelta.be

    Dries DEEREN, MD

    Recruiting

Other trials in Belgium

United States2 sites, 2 recruiting

  • University of Kansas Cancer Center

    Fairway, Kansas, 66205

    Tara LIN, MD, 913-945-5052

    Tara LIN, MD

    Recruiting

  • Mayo Clinic Cancer Center

    Jacksonville, Florida, 32224

    Mohamed Kharfan Dabaja, MD, 904-953-3376

    Mohamed Kharfan Dabaja, MD

    Not yet recruiting

Other trials in United States

About this study

Official title: Open-label, Phase I, Multi-center Study to Determine in Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Patients the Recommended Dose of CYAD-02 After a Non-myeloablative Preconditioning Chemotherapy Followed by a Potential Consolidation Cycle

An open-label, phase I, multi-center study to determine in relapsed/refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients the recommended dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a potential CYAD-02 consolidation cycle for non-progressive patient. A maximum of 27 r/r AML/MDS patients will be evaluated in this study in case of no dose limiting toxicity (DLT) and no replacement of patients.

Read the detailed description

This open-label phase I, multi-center study aims to determine in relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome patients the recommended dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a potential CYAD-02 consolidation cycle for non-progressive patients.

During dose escalation, three prespecified dose-levels of CYAD-02 will be evaluated in three cohorts. Patient enrollment during dose-escalation will be staggered according to the Fibonacci 3+3 design and extension of cohorts II and III will be done in parallel. The first CYAD-02 infusion will be administered after prior non-myeloablative preconditioning chemotherapy (CYFLU) administered on three consecutive days.

Non-progressive patients meeting the criteria specified below may receive a consolidation cycle with three additional CYAD-02 infusions at a 2-week interval without prior preconditioning.

For all patients who received at least one CYAD-02 infusion, the overall study duration will be approximately 15 years.

Being tested
CYAD-02, ENDOXAN, Fludara
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

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

  • CYAD-02Biological

    CYAD-02 is a Chimeric Antigen Receptor-T (CAR-T) administered after CYFLU.

  • ENDOXANDrug

    Also called cyclophosphamide

    administered as preconditioning chemotherapy

  • FludaraDrug

    Also called fludarabine

    administered as preconditioning chemotherapy

Study groups in NCT04167696
Study groupRoleWhat they receive
Dose Escalation Dose Level 1Experimentalin case of no dose limiting toxicity (DLT) and no replacement of patients, 3 consecutive patients at the dose of 1x10e8 of CYAD-02 per infusion post preconditioning non-myeloablative chemotherapy according to a 3+3 study design. The preconditioning therapy consists of 3 consecutive days of cyclophosphamide (300 mg/m²/day) and fludarabine (30 mg/m²/day), two days before the CYAD-02 infusion. In case of no progression at D22, the patient is eligible to receive a consolidation cycle of 3 additional CYAD-02 infusion at the same dose level, without prior preconditioning chemotherapy.
Receives: Biological: CYAD-02; Drug: ENDOXAN; Drug: Fludara
Dose Escalation Dose Level 2Experimentalin case of no dose limiting toxicity (DLT) and no replacement of patients,3 consecutive patients at the dose of 3x10e8 of CYAD-02 per infusion post preconditioning non-myeloablative chemotherapy according to a 3+3 study design. The preconditioning therapy consists of 3 consecutive days of cyclophosphamide (300 mg/m²/day) and fludarabine (30 mg/m²/day), two days before the CYAD-02 infusion. In case of no progression at D22, the patient is eligible to receive a consolidation cycle of 3 additional CYAD-02 infusion at the same dose level, without prior preconditioning chemotherapy.
Receives: Biological: CYAD-02; Drug: ENDOXAN; Drug: Fludara
Dose Escalation Dose Level 3Experimentalin case of no dose limiting toxicity (DLT) and no replacement of patients,3 consecutive patients at the dose of 1x10e9 of CYAD-02 per infusion post preconditioning non-myeloablative chemotherapy according to a 3+3 study design. The preconditioning therapy consists of 3 consecutive days of cyclophosphamide (300 mg/m²/day) and fludarabine (30 mg/m²/day), two days before the CYAD-02 infusion. In case of no progression at D22, the patient is eligible to receive a consolidation cycle of 3 additional CYAD-02 infusion at the same dose level, without prior preconditioning chemotherapy.
Receives: Biological: CYAD-02; Drug: ENDOXAN; Drug: Fludara

What is being measured

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

  1. Occurrence of Dose Limiting Toxicities as defined per protocol in order to define the final recommended dose.

    Measured: from start the first infusion of CYAD-02 (Day1) up to Day36.

Timeline

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

  1. First posted19 Nov 2019
  2. Study start25 Nov 2019
  3. Primary completionDec 2021 (estimated)
  4. Study completionFeb 2035 (estimated)

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
Sequential
Model description
Dose escalation
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04167696
Sponsor's protocol ID
CYAD-02-001
Acronym
CYCLE-1
Status last verified
Jun 2020
First submitted
12 Nov 2019
Last updated
9 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CYAD-02, ENDOXAN and Fludara in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Celyad Oncology SA at 5 sites in 2 countries.

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: looking for participants now, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Belgium, 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Frederic LEHMANN, MD, PhD (003210394100, flehmann@celyad.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Dose Limiting Toxicities as defined per protocol in order to define the final recommended dose. (time frame: from start the first infusion of CYAD-02 (Day1) up to Day36.). 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 NCT04167696.

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 Jun 2020.

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