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New treatment option for MDS (Myelodysplastic Syndrome)
Official title Luspatercept + Darbepoetin in MDS
ClinicalTrials.gov ID: NCT07096297
What this study is testing
What is Luspatercept?
Luspatercept is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for mds (myelodysplastic syndrome).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single arm open-label Phase II trial of luspatercept and darbepoetin alfa in non-mutated SF3B1 , lower-risk, RBC transfusion dependent MDS participants with an endogenous erythropoietin (EPO) level \< 500 IU/L.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Ability to understand and the willingness to sign a written informed consent document.
- Participant is 18 years or older at the time of signing informed consent.
- Participant has lower-risk myelodysplastic syndrome (MDS) defined as very low, low and intermediate risk by International Prognostic Scoring...
- Bone marrow biopsy within 90 days of screening demonstrated less than 5% blasts in the aspirate and/or core biopsy. If no bone marrow biopsy was done...
- Absence of SF3B1 mutation and del5q.
You likely can't join if
- Prior treatment with ESA, luspatercept, hypomethylating agents or lenalidomide/thalidomide/other immunomodulating drug (IMiDs).
- Exception 1: Participants can have received ≤ 2 doses of prior epoetin alfa or ≤ 1 dose darbepoetin alfa if ≥ 8 weeks from date of consent.
- Exception 2: Participants can have received ≤ 1 week of treatment with lenalidomide ≥ 8 weeks from the date of consent, at the sponsor-investigator's...
- After signing consent, the participants are not allowed to receive any of these drugs: other RBC hematopoietic growth factors (e.g., Interleukin-3)...
- Participants with history of seizures at any time.
- Participants with any of the following conditions within six months prior to screening:
See the full eligibility criteria
- Ability to understand and the willingness to sign a written informed consent document.
- Participant is 18 years or older at the time of signing informed consent.
- Participant has lower-risk myelodysplastic syndrome (MDS) defined as very low, low and intermediate risk by International Prognostic Scoring System-Revised (IPSS-R) criteria (3).
- Bone marrow biopsy within 90 days of screening demonstrated less than 5% blasts in the aspirate and/or core biopsy. If no bone marrow biopsy was done within 90 days of screening it is mandatory to repeat it at...
- Absence of SF3B1 mutation and del5q.
- Endogenous serum erythropoietin alfa (EPO) level \< 500 IU/L.
- Participant is transfusion dependent defined as ≥ 2 packed red blood cell (PRBC) units/8 weeks for a minimum of eight weeks immediately prior to screening. The maximum consecutive timeframe participants may be RBC...
- Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (Appendix 1. ECOG Performance Status Scale).
- Participant has adequate organ function defined as:
- Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3 x ULN, unless considered due to organ involvement by the participant's myeloid malignancy...
- Serum direct bilirubin \< 1.5 x ULN.
- Creatinine clearance \> 30 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR) estimation.
- Participants must adhere to the following reproductive and contraceptive requirements while on study treatment and for three months after the last dose of luspatercept and darbepoetin alfa: a. General Requirements: i...
- Prior treatment with ESA, luspatercept, hypomethylating agents or lenalidomide/thalidomide/other immunomodulating drug (IMiDs).
- Exception 1: Participants can have received ≤ 2 doses of prior epoetin alfa or ≤ 1 dose darbepoetin alfa if ≥ 8 weeks from date of consent.
- Exception 2: Participants can have received ≤ 1 week of treatment with lenalidomide ≥ 8 weeks from the date of consent, at the sponsor-investigator's discretion.
- After signing consent, the participants are not allowed to receive any of these drugs: other RBC hematopoietic growth factors (e.g., Interleukin-3), granulocyte colony stimulating factors (i.e., G-CSF, GM-CSF), except...
- Participants with history of seizures at any time.
- Participants with any of the following conditions within six months prior to screening:
- Stroke.
- Thrombosis/thromboembolism.
- Myocardial infarction.
- Uncontrolled angina.
- Acute decompensated cardiac failure or New York Heart Association (NYHA) Class III-IV heart failure.
- Uncontrolled cardiac arrhythmia as determined by the investigator.
- Participant has immediate life-threatening, severe complications of their myeloid malignancy such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.
- Participants with uncontrolled hypertension defined as systolic blood pressure (SBP) of ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment. Participant with history of cerebrovascular...
- Participant has active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or active infection with hepatitis C virus (HCV). Participants with HIV that is controlled...
- Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy...
- Participant who is pregnant or lactating.
- Pregnant participants are excluded from this study because luspatercept has shown in animal studies to be potentially associated with fetal harm.
- Because there is an unknown but potential risk for AE in nursing infants secondary to treatment, lactating participants are excluded from this study.
- Participant with prior history of malignancies, other than MDS, unless the participant has been free of the disease for ≥ 5 years. However, participants with the following history/concurrent conditions are allowed:
- Basal or squamous cell carcinoma of the skin.
- Carcinoma in situ of the cervix.
- Carcinoma in situ of the breast.
- Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis TNM clinical staging system).
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Chicago, Illinois, United States
- Dallas, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Chicago, Illinois, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.