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Expanded Access for Treatment With Imetelstat

Primary Purpose

Myelodysplastic Syndromes

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Imetelstat
Sponsored by
Geron Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Myelodysplastic Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Key Inclusion Criteria: Documented diagnosis of MDS according to World Health Organization (WHO) criteria confirmed by bone marrow aspirate and/or biopsy preferably within 24 but no more than 52 weeks prior to EAP start. Very Low, Low, or Intermediate risk MDS (≤3.5) per IPSS-R. Red blood cell (RBC) transfusion dependent, defined as requiring at least 4 RBC units over an 8-week period during the 16 weeks prior to EAP entry; pre-transfusion hemoglobin (Hb) should be less than or equal to 9.0 grams per deciliter (g/dL) to count towards the 4 units total. Has MDS that has failed to respond or has lost response or are ineligible for ESAs. To ensure participants have adequate iron stores they must have transferrin saturation greater than 20% and serum ferritin greater than 400 nanograms per milliliter (ng/mL). Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2. Hematology and biochemical laboratory test values within the protocol defined limits. Have no approved alternative treatment available. Inability to participate in a current imetelstat clinical study for the disease or conditions. Have a treating physician who has appropriately evaluated the benefit/risk profile for potential imetelstat treatment. Key Exclusion Criteria: Have previously assessed as having IPSS-R high or very high risk MDS. Participant with del(5q) karyotype. Participant with MDS/myeloproliferative neoplasm Overlap Syndromes. Participant has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients. Participant has received an experimental or investigational product or used an invasive investigational medical device within 30 days prior to EAP entry or is currently enrolled in an investigational study. Prior treatment with imetelstat; or eligible for enrollment in an ongoing imetelstat clinical trial. Prior treatment with lenalidomide or a hypomethylating agent (example, azacitidine, decitabine, or decitabine/cedazuridine). Has received an ESA or any anti-MDS therapy, chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior to EAP entry. Prior history of hematopoietic stem cell transplant. Note: Other protocol specified inclusion/exclusion criteria may apply.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 30, 2023
    Last Updated
    June 30, 2023
    Sponsor
    Geron Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05937568
    Brief Title
    Expanded Access for Treatment With Imetelstat
    Official Title
    Expanded Access Treatment With Imetelstat For Adult Participants With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Are Transfusion-Dependent And Have Failed to Respond or Have Lost Response or Are Ineligible For Erythropoiesis-Stimulating Agents (ESAs)
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Geron Corporation

    4. Oversight

    5. Study Description

    Brief Summary
    The objective of this expanded access protocol (EAP) is to provide access to treatment with imetelstat, the Investigational Product (IP), for eligible adult participants diagnosed with very low, low, intermediate risk (by Revised International Prognostic Scoring System, IPSS-R) myelodysplastic syndromes (MDS) who are red blood cell (RBC) transfusion-dependent, have failed to respond or have lost response or are ineligible for ESAs, had not received prior treatment with either a hypomethylating agent or lenalidomide and were non-del(5q), until such time that imetelstat becomes commercially available.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myelodysplastic Syndromes

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Imetelstat
    Intervention Description
    Participants will receive imetelstat, intravenously (IV) by infusion every 4 weeks.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Key Inclusion Criteria: Documented diagnosis of MDS according to World Health Organization (WHO) criteria confirmed by bone marrow aspirate and/or biopsy preferably within 24 but no more than 52 weeks prior to EAP start. Very Low, Low, or Intermediate risk MDS (≤3.5) per IPSS-R. Red blood cell (RBC) transfusion dependent, defined as requiring at least 4 RBC units over an 8-week period during the 16 weeks prior to EAP entry; pre-transfusion hemoglobin (Hb) should be less than or equal to 9.0 grams per deciliter (g/dL) to count towards the 4 units total. Has MDS that has failed to respond or has lost response or are ineligible for ESAs. To ensure participants have adequate iron stores they must have transferrin saturation greater than 20% and serum ferritin greater than 400 nanograms per milliliter (ng/mL). Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2. Hematology and biochemical laboratory test values within the protocol defined limits. Have no approved alternative treatment available. Inability to participate in a current imetelstat clinical study for the disease or conditions. Have a treating physician who has appropriately evaluated the benefit/risk profile for potential imetelstat treatment. Key Exclusion Criteria: Have previously assessed as having IPSS-R high or very high risk MDS. Participant with del(5q) karyotype. Participant with MDS/myeloproliferative neoplasm Overlap Syndromes. Participant has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients. Participant has received an experimental or investigational product or used an invasive investigational medical device within 30 days prior to EAP entry or is currently enrolled in an investigational study. Prior treatment with imetelstat; or eligible for enrollment in an ongoing imetelstat clinical trial. Prior treatment with lenalidomide or a hypomethylating agent (example, azacitidine, decitabine, or decitabine/cedazuridine). Has received an ESA or any anti-MDS therapy, chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior to EAP entry. Prior history of hematopoietic stem cell transplant. Note: Other protocol specified inclusion/exclusion criteria may apply.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    WEP Clinical
    Phone
    919-694-5088
    Email
    GeronEAP@wepclinical.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shyamala Navada, MD
    Phone
    650-980-4256
    Email
    mdseap-info@geron.com

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Access for Treatment With Imetelstat

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