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New treatment option for Myelodysplastic Syndromes
Official title A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
ClinicalTrials.gov ID: NCT03886662
What this study is testing
What is LB-100?
LB-100 is an investigational medicine, given as an infusion into a vein, 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
- The purpose of this study is to test the safety and efficacy (benefits) of an investigational drug LB-100, for treatment of myelodysplastic syndromes. LB-100 has previously been administered to patients with various solid tumors.
- 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
- Patient has signed the Informed Consent Form (ICF) and is able to comply with protocol requirements.
- Patient has adequate organ function as defined by the following laboratory values:
- Creatinine clearance (CrCl) ≥ 60ml/min
- Total serum bilirubin \< 1.5 x Upper Limit of Normal (ULN) or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range only in patients...
- Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) \< 3.0 x ULN
You likely can't join if
- Patient has a known history of HIV infection (testing not mandatory).
- Patient has any of the following cardiac abnormalities:
- symptomatic congestive heart failure
- myocardial infarction ≤ 6 months prior to enrollment
- unstable angina pectoris as designated by the treating physician
- serious uncontrolled cardiac arrhythmia as designated by the treating physician
See the full eligibility criteria
- Patient has signed the Informed Consent Form (ICF) and is able to comply with protocol requirements.
- Patient has adequate organ function as defined by the following laboratory values:
- Creatinine clearance (CrCl) ≥ 60ml/min
- Total serum bilirubin \< 1.5 x Upper Limit of Normal (ULN) or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range only in patients with well documented Gilbert's syndrome or hemolysis or who required...
- Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) \< 3.0 x ULN
- Age ≥18 years at the time of signing the informed consent form.
- Documented diagnosis of MDS or MDS/myeloproliferative neoplasm (MPN) by World Health Organization (WHO) criteria that require treatment due to cytopenias and meet the International Prognostic Scoring System (IPSS)...
- For non-del(5q) patients, failed prior treatment with at least 2 cycles started of azacitidine or decitabine or lenalidomide defined as no response to treatment, loss of response at any time point while on treatment or...
- For del(5q) patients, failed prior treatment with at least 2 cycles started of lenalidomide defined as no response to treatment, loss of response at any time point, or progressive disease/intolerance to therapy.
- An Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence; tubal ligation, partner's vasectomy) prior to Cycle 1 Day 1 (C1D1) and for the...
- Patient has a known history of HIV infection (testing not mandatory).
- Patient has any of the following cardiac abnormalities:
- symptomatic congestive heart failure
- myocardial infarction ≤ 6 months prior to enrollment
- unstable angina pectoris as designated by the treating physician
- serious uncontrolled cardiac arrhythmia as designated by the treating physician
- QTcF (Fridericia's correction formula) ≥ 450 msec
- Concomitant malignancies or previous malignancies with less than a 1-year disease free interval at the time of enrollment. Patients with adequately resected basal or squamous cell carcinoma of the skin, or adequately...
- Use of chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 14 days of the first day of study drug treatment.
- No concurrent use of erythroid stimulating agents, Granulocyte-colony stimulating factor (G-CSF), Granulocyte-macrophage colony-stimulating factor (GM-CSF) is allowed during study except in cases of febrile neutropenia...
- Pregnant women are excluded from this study because LB-100 has not been studied in pregnant people. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the...
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
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 Tampa, Florida, 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.