Luspatercept and Lenalidomide (L2) in Lower-risk, Non-del(5q) MDS Patients (NCT04539236) | Clinical Trial Compass
SuspendedPhase 1/2
Luspatercept and Lenalidomide (L2) in Lower-risk, Non-del(5q) MDS Patients
Stopped: Funding Sponsor decision
United States50 participantsStarted 2021-11-09
Plain-language summary
The purpose of this study is to evaluate if the combination of drugs, Lenalidomide and Luspatercept, will help improve the treatment of anemia in patients with lower-risk Myelodysplastic Syndrome (MDS).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is ≥ 18 years of age the time of signing the informed consent form (ICF).
✓. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
✓. Documented diagnosis of MDS according to World Health Organization (WHO) / French-American-British (FAB) classification that meets International Prognostic Scoring System Revised (IPSS-R) classification (Greenberg, 2012) of very low, low, or intermediate risk disease; intermediate patients must have a blast percentage \<5% to be enrolled.
✓. Subjects can be ESA-naïve, or refractory or intolerant to, or ineligible for, prior ESA treatment, as defined by any one of the following:
✓. If previously treated with ESAs, agents must have been discontinued ≥ 4 weeks prior to date of C1D1.
✓. Requires RBC transfusions, as documented by the following criteria:
✓. Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 (Appendix 1)
✓. Females of childbearing potential (FCBP), 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 does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months), must:
Exclusion criteria
✕. Prior therapy with Lenalidomide.
✕
What they're measuring
1
MTD/RP2D of Luspatercept combined with Lenalidomide
. Previously treated with either luspatercept (ACE-536) or sotatercept (ACE-011)
✕. MDS associated with del 5q cytogenetic abnormality
✕. Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
✕. Prior allogeneic stem cell transplant
✕. Known history of diagnosis of AML
✕. Use of any of the following within 4 weeks prior to C1D1:
✕. Uncontrolled hypertension, defined as repeated elevations of diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment.