BridgeMD
Tests treatment safety and results for Myelodysplastic Syndromes
Official title Efficacy and Safety of Luspatercept for the Treatment of Anemia Due to MDS With del5q, Refractory/Resistant/Intolerant to Prior Treatments, RBC-TD
ClinicalTrials.gov ID: NCT05924100
What this study is testing
What is Luspatercept Injection [Reblozyl]?
Luspatercept Injection [Reblozyl] is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for myelodysplastic syndromes.
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
- Myelodysplastic syndromes, primarily affecting older adults, are a heterogeneous group of clonal disorders of hematopoietic stem cells characterized by ineffective hematopoiesis that manifest clinically as anemia, neutropenia, and/or thrombocytopenia of variable severity; these often result in RBC- transfusion dependent (TD) anemia, increased risk of infection, and/or hemorrhage, as well as a potential to progress to acute myeloid leukemia (AML). Lenalidomide is approved for red blood cell transfusion-dependent (RBC TD) anemia due to low-risk myelodysplastic syndromes (MDS) with a chromosome 5q deletion (del5q) with or without additional cytogenetic abnormalities.
- 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
You may be able to join if
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Documented diagnosis of MDS with del5q according to 2018 WHO classification
- IPSS-R classification (Greenberg, 2012) of very low, low, or intermediate risk disease, and:
- \< 5% blasts in bone marrow
- Peripheral blood WBC count \<13,000/μL
You likely can't join if
- P53 mutation at screening
- Prior therapy with disease modifying agents for underlying MDS disease (hypomethylating agents)
- people who previously received HMA may be enrolled at the investigator's discretion contingent that the subject received no more than 1 dose of HMA)...
- Previously treated with either luspatercept (ACE-536) or sotatercept (ACE-011)
- Secondary MDS, ie, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other...
- anticancer cytotoxic chemotherapeutic agent or treatment
See the full eligibility criteria
Who can join
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Documented diagnosis of MDS with del5q according to 2018 WHO classification
- IPSS-R classification (Greenberg, 2012) of very low, low, or intermediate risk disease, and:
- \< 5% blasts in bone marrow
- Peripheral blood WBC count \<13,000/μL
- Refractory or intolerant to, or ineligible for, prior ESA treatment
- If previously treated with ESAs or granulocyte colony-stimulating factor (G-CSF), both agents must have been discontinued ≥ 4 weeks prior to date of screening.
- Refractory or intolerant to, or ineligible for, prior lenalidomide treatment, as defined by any one of the following:
- Refractory to prior lenalidomide treatment for at least 4 cycles; - documentation of non-response or response that is no longer maintained (HI-E)
- Intolerant to prior lenalidomide treatment - documentation of discontinuation of lenalidomide at any time after introduction due to intolerance or an adverse event
- lenalidomide ineligible -platelet counts below 50000/mmc or absolute neutrophil count below 500/mmc at the start of treatment
- lenalidomide must have been discontinued ≥ 4 weeks prior to date of screening. Requires RBC transfusions, as documented by the following criteria:
- average transfusion requirement of ≥ 2 units/8 weeks of pRBCs confirmed for a minimum of 16 weeks immediately preceding enrolment.
- Hb levels at the time of or within 7 days prior to administration of a RBC transfusion must have been ≤ 10.0 g/dL in order for the transfusion to be counted towards meeting eligibility criteria. RBC transfusions...
- no consecutive 56-day period that was RBC transfusion-free during the 16 weeks immediately preceding screening
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
- Females of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy...
- Have two negative pregnancy tests as verified by the Investigator prior to starting study therapy (unless the screening pregnancy test was done within 72 hours of C1D1). Refer to Section 6.1 for additional details. She...
- If sexually active, agree to use, and be able to comply with, highly effective contraception without interruption, 5 weeks prior to starting investigational product, during the study therapy (including dose...
- Male people must:
- Agree to use a condom, defined as a male latex condom or non latex condom not made out of natural (animal) membrane (for example, polyurethane), during sexual contact with a pregnant female or a female of childbearing...
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
What rules you out
- P53 mutation at screening
- Prior therapy with disease modifying agents for underlying MDS disease (hypomethylating agents)
- people who previously received HMA may be enrolled at the investigator's discretion contingent that the subject received no more than 1 dose of HMA). The last dose must be ≥ 5 weeks from the date of screening.
- Previously treated with either luspatercept (ACE-536) or sotatercept (ACE-011)
- Secondary MDS, ie, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases. 5 Known clinically significant anemia due to iron, vitamin B12, or...
- anticancer cytotoxic chemotherapeutic agent or treatment
- corticosteroid, except for people on a stable or decreasing dose for ≥ 1 week prior to study entry for medical conditions other than MDS
- iron-chelating agents, except for people on a stable or decreasing dose for at least 8 weeks prior to screening
- other RBC hematopoietic growth factors
- investigational drug or device, or approved therapy for investigational use. If the half- life of the previous investigational product is known, use within 5 times the half- life prior to screening or within 5 weeks...
- higher levels are acceptable if these can be attributed to active red blood cell precursor destruction within the bone marrow (ie, ineffective erythropoiesis) or in the presence of known history of Gilbert Syndrome.
- people are excluded if there is evidence of autoimmune hemolytic anemia 13. Prior history of malignancies, other than MDS, unless the subject has been free of the disease (including completion of any active or adjuvant...
- 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
- Alessandria, Italy
- Ancona, Italy
- Avellino, Italy
- Biella, Italy
- Catania, Italy
- Chivasso, Italy
- Cosenza, Italy
- Florence, Italy
- Naples, Italy
- Novara, Italy
- Palermo, Italy
- Pescara, Italy
- Reggio Calabria, Italy
- Reggio Emilia, Italy
- Roma, Italy
- Salerno, Italy
- San Giovanni Rotondo, Italy
- Terni, Italy
- Torino, Italy
- Trieste, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alessandria, Italy; Ancona, Italy; Avellino, Italy; Biella, Italy; Catania, Italy; Chivasso, Italy and 14 more location(s). 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.