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The Tapering Dose of Luspatercept in Patients With Lower-risk Myelodysplastic Syndromes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05925504
Recruitment Status : Recruiting
First Posted : June 29, 2023
Last Update Posted : March 12, 2024
Sponsor:
Collaborator:
Beijing Health Alliance Charitable Foundation
Information provided by (Responsible Party):
Gao Zhen, Institute of Hematology & Blood Diseases Hospital, China

Study Description
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Brief Summary:
This is a prospective, single center, single-arm, phase 2 study. The aim of this study is to evaluate the efficacy and safety of Luspatercept for Patients with Lower-risk Myelodysplastic Syndromes (MDS).

Condition or disease Intervention/treatment Phase
Lower Risk MDS Per IPSS-R Drug: Luspatercept Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of the Tapering Dose of Luspatercept in Patients With Lower-risk Myelodysplastic Syndromes
Actual Study Start Date : July 1, 2023
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : September 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Luspatercept
open-label, single-arm
 Drug: Luspatercept
The starting dose is 1.75mg/kg once every 3 weeks by subcutaneous injection. For rapid hemoglobin rise after 2 consecutive doses at the 1.75mg/kg starting dose, decrease the dose of Luspatercept or interrupt treatment. Otherwise, continue treatment with the dose of 1.75mg/kg once every 3 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects achieving hematologic improvement - erythroids (HI-E) according to IWG 2006 criteria [ Time Frame: within 12 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving RBC-TI according to IWG 2006 criteria [ Time Frame: within 12 weeks ]
  2. Median time to HI-E or RBC-TI [ Time Frame: within 12 weeks ]
  3. Mean change in serum ferritin [ Time Frame: within 12 weeks ]
  4. Incidence of the adverse event [ Time Frame: within 12 weeks ]
    Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female age ≥ 18 years
  • Subject has diagnosis of MDS according to WHO classification that meets IPSS-R score ≤3.5
  • Hemoglobin < 100g/L at baseline
  • Refractory or intolerant to prior ESA treatment or EPO≥500U/L
  • ECOG performance status ≤2
  • Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

  • Platelet counts < 50 x 10^9/L
  • Previously treated with either luspatercept or sotatercept

  • Use any of the following prior to this study

    • Immunomodulatory drugs such as lenalidomide [IMiD] for ≥4 weeks
    • Immunosuppressive therapy [IST] for ≥4 weeks
    • Demethylating agents [HMA] ≥ 1 cycle of treatment
  • MDS associated with del 5q cytogenetic abnormality
  • Secondary MDS, i.e. MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases.
  • Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding.
  • Prior allogeneic or autologous stem cell transplant.
  • Prior history of malignancies, other than MDS, unless the subject is free of the disease (including completion of any active or adjuvant treatment for prior malignancy) for ≥ 5 years. However, subjects with the following history/concurrent conditions are allowed: basal or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasia, carcinoma in situ of the cervix or other indolent tumors.
  • Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment), known human immunodeficiency virus (HIV), known evidence of active infectious hepatitis B, and/or known evidence of active hepatitis C.
  • Clinically significant cardiac disease, including any of the follow: uncontrolled angina pectoris, myocardial infarction, unstable cardiac arrhythmias, congestive heart failure and New York Heart Association (NYHA) grade 2-4 cardiac failure.
  • Abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that ALT and AST are 2.5 times higher than the upper limit of normal values
  • Renal impairment: creatinine clearance <60ml/min
  • Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including clinically significant cardiac diseases, refractory hypertension, metabolic disorders and other diseases that seriously affect the function of the gastrointestinal tract.
  • Had a history of any psychiatric diseases, cerebrovascular disease or cognitive sequelae of head injury.
  • Major surgery within 8 weeks prior to this study. Subjects must be completely recovered from any previous surgery prior to this study.
  • Received attenuated vaccine in 4 weeks before enrollment.
  • Participation in another clinical trial within 4 weeks before the start of this trial.
  • History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the luspatercept.
  • Pregnant or breast-feeding patients
  • Patients considered to be ineligible for the study by the investigator for reasons other than the above.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05925504


Contacts
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Contact: Zhen Gao ‭15522360862‬ gaozhen@ihcams.ac.cn
Contact: Jingyu Zhao 13752253515 zhaojingyu@ihcams.ac.cn

Locations
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China, Tianjin
Regenerative Medicine Center Recruiting
Tianjin, Tianjin, China, 300131
Contact: Zhen Gao, MD    13752253515    gaozhen@ihcams.ac.cn   
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital, China
Beijing Health Alliance Charitable Foundation
More Information
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Responsible Party: Gao Zhen, Physician of Regenerative Medical Center, Institute of Hematology & Blood Diseases Hospital, China
ClinicalTrials.gov Identifier: NCT05925504    
Other Study ID Numbers: Lusp-MDS
First Posted: June 29, 2023    Key Record Dates
Last Update Posted: March 12, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
 Precancerous Conditions
Neoplasms
Luspatercept
Hematinics