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Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy

Rekrutierend

NCT-Nummer:
NCT05583552

Studienbeginn:
Juni 2023

Letztes Update:
06.02.2024

Wirkstoff:
Imetelstat

Indikation (Clinical Trials):
Preleukemia, Myelodysplastic Syndromes, Syndrome

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
GCP-Service International West GmbH

Collaborator:
Geron Corporation, Universitätsklinikum Leipzig, Saint-Louis Hospital, Paris, France, QIMR Berghofer Medical Research Institute, Australasian Leukaemia and Lymphoma Group, Groupe Francophone des Myelodysplasies, German Myelodysplastic Syndrome Study Group,

Studienleiter

Uwe Platzbecker, MD
Principal Investigator
Universitätsklinikum Leipzig

Kontakt

Studienlocations
(3 von 12)

Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to evaluate the efficacy, in terms of hematologic improvement,

and safety of imetelstat in participants with high-risk (HR) myelodysplastic syndrome (MDS)

or acute myeloid leukemia (AML) that is relapsed/refractory to hypomethylating agents (HMAs)

treatment. Responding patients are eligible to continue treatment until loss of

response/disease progression.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Signed written informed consent

- Male and female ≥ 18 years at the first screening

- Must be able to adhere to the study visit schedule and other protocol requirements

- Initial diagnosis of AML or MDS according to WHO 2016 classification

- At least one cytopenia

- Failure to achieve complete or partial response or hematological improvement observed

after at least six azacitidine monotherapy or four decitabine monotherapy based 4-week

treatment cycles administered during the past two years OR Failure to achieve complete

or partial response or hematological improvement observed after at least two 4-week

treatment cycles with azacitidine plus venetoclax or with decitabine plus venetoclax

during the past two years OR Relapse after initial complete or partial response or

hematological improvement observed after at least six (azacitidine) or four

(decitabine) based 4-week treatment cycles administered during the past two years OR

Relapse after initial complete or partial response or hematological improvement

observed after at least two 4-week treatment cycles with azacitidine plus venetoclax

or with decitabine plus venetoclax during the past two years OR Intolerance to

treatment with HMA-based therapy during the past two years

- Not eligible for allogeneic stem cell transplantation

- ≥ 5% bone marrow blasts at screening

- Off all other treatments for AML/MDS for at least 14 days; granulocyte

colony-stimulating factor (G-CSF) and erythropoietin are allowed before and during the

study as clinically indicated

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Biochemical laboratory test values must be within the defined limits.

- Availability of blood counts and transfusion events for previous 16 weeks

- Women of childbearing potential and practicing a highly effective method of birth

control consistent with local regulations regarding the use of birth control methods

for subjects participating in clinical studies. For females, these restrictions apply

for 3 months after the end of dosing.

- A woman of childbearing potential must have a negative serum or urine pregnancy test

at screening and agree to be tested on day 1 of every cycle and at End of Treatment

(EOT)

- A man who is sexually active with a woman of childbearing potential and has not had a

vasectomy must agree to use a barrier method of birth control. For males, these

restrictions apply for 3 months after the end of dosing

Exclusion Criteria:

- Chemotherapy within the 14 days prior to the first dose of imetelstat being

administered (other than hydroxyurea)

- Participant has known allergies, hypersensitivity, or intolerance to imetelstat or its

excipients (refer to the Investigators Brochure (IB))

- Participant has received an experimental or investigational drug or used an invasive

investigational medical device within 30 days prior to day 1 of Cycle 1

- Prior treatment with imetelstat

- Prior history of intensive chemotherapy or hematopoietic stem cell transplant

- Major surgery within 4 weeks prior to day 1 of Cycle 1 (excluding the placement of

vascular access and other minor surgical procedures)

- Diagnosed or treated for malignancy other than MDS or AML, except:

Malignancy treated with curative intent and with no known active disease present for 3

years before day 1 of Cycle 1 Adequately treated non-melanoma skin cancer or lentigo

maligna without evidence of disease Adequately treated cervical carcinoma in situ without

evidence of disease

- Clinically significant cardiovascular disease such as uncontrolled or symptomatic

arrhythmias, congestive heart failure, or myocardial infarction within 6 months of day

1 of Cycle 1, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined

by the New York Heart Association Functional Classification

- Known history of human immunodeficiency virus (HIV) or any uncontrolled active

systemic infection requiring IV antibiotics

- Active systemic hepatitis infection requiring treatment (carriers of hepatitis virus

are permitted to enter the study), or known acute or chronic liver disease including

cirrhosis

- Any life-threatening illness, medical condition, or organ system dysfunction which, in

the investigator's opinion, could compromise the participant 's safety, interfere with

the imetelstat metabolism, or put the study outcomes at undue risk; Participant has

any condition for which, in the opinion of the investigator, participation would not

be in the best interest of the participant (eg, compromise the well-being) or that

could prevent, limit, or confound the protocol-specified assessments

- Females who are pregnant or are currently breastfeeding or planning to become pregnant

while enrolled in this study or within 3 months after the end of dosing

- Participant is a man who plans to father a child while enrolled in this study or

within 3 months after the end of dosing

- Other:

Participant is in custody by order of an authority or a court of law Participation in

another interventional clinical study within the last 3 months prior to signing the

Informed consent form (ICF) or simultaneous participation in other interventional clinical

studies Previous assignment to treatment during this study Close affiliation with the

investigator (e.g., a close relative) or persons working at the study site Participant is

an employee of the sponsor or involved Contract Research Organization (CRO) Criteria which

in the opinion of the investigator preclude participation for scientific reasons, for

reasons of compliance, or for reasons of the Participant's safety

Studien-Rationale

Primary outcome:

1. Overall Hematological Response Rate of Participants after Treatment with Imetelstat (Time Frame - After 4 Months of Treatment):
The combined response assessment criteria for MDS and AML based on IWG 2018 criteria (MDS) and the criteria of the European LeukemiaNet (AML) will be used to define responders. The response rate is calculated as number of responders divided by the number of all participants of the analysis set.

Geprüfte Regime

  • Imetelstat (GRN163L):
    Intravenous injection

Quelle: ClinicalTrials.gov


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