Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA
- Conditions
- Myelodysplastic Syndromes
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Adequate organ function as defined by laboratory values per protocol<br><br> - Documented diagnosis of MDS by World Health Organization (WHO) criteria, further<br> meeting the following criteria according to disease risk classification<br><br> - Patients must be transfusion dependent, defined as requirement for transfusion of at<br> least 3 units of Packed Red Blood cells (PRBCs) 16 weeks for a Hgb<9.0g/dL or, in<br> non-transfusion dependent patients (<3 units of PRBCs transfused in the preceding 16<br> weeks), must have a baseline Hgb of <9.0 g/dL at time of study enrollment<br><br> - Eastern Cooperative Oncology Group (ECOG) Performance Status </=2.<br><br> - Women of child bearing potential must have negative urine or serum pregnancy test<br> within 28 days prior to start of study drug.<br><br> - Women of child bearing potential must agree to use adequate contraception (hormonal<br> or barrier method of birth control; abstinence; tubal ligation, partner's vasectomy)<br> prior to Cycle 1 Day 1 and for the duration of study participation.<br><br>Exclusion Criteria:<br><br> - Use of chemotherapeutic agents or experimental agents (agents that are not<br> commercially available) for the treatment of MDS within 14 days of the first day of<br> study drug treatment.<br><br> - Previous treatment with a hypomethylating agent (such as azacitidine, decitabine or<br> investigational hypomethylating agent).<br><br> - Use of concurrent growth factors such as G-CSF, GM-CSF, or thrombopoietin mimetics<br> during study except in cases of febrile neutropenia, where G-CSF can be used for<br> short term. Growth factors must be stopped two weeks prior to study.<br><br> - Patient has any of the following cardiac abnormalities: (a) Uncontrolled,<br> symptomatic congestive heart failure as designated by the treating physician (b)<br> Myocardial infarction = 6 months prior to enrollment (c) Unstable angina pectoris as<br> designated by the treating physician (d) Serious uncontrolled cardiac arrhythmia as<br> designated by the treating physician. (e) Uncontrolled hypertension as designated by<br> the treating physician<br><br> - Known history of human immunodeficiency virus (HIV) (no laboratory testing is<br> required), or active infection with Hepatitis B or Hepatitis C.<br><br> - Active tuberculosis (Tb) infection or documented, untreated latent Tb infection (all<br> patients should undergo Tb risk evaluation prior to enrollment with Tb screening<br> performed as per local guidelines,<br><br> - Active, uncontrolled infection at the time of enrollment, except in cases of<br> localized infections that are unlikely to lead to a systemic infection such as<br> onychomycoses or dental caries. Patients with new fever (> 38.0 C) or respiratory<br> symptoms are required to undergo laboratory screening for COVID-19<br><br> - Have undergone prior allo-HSCT for the treatment of MDS, or other hematologic<br> disorder, or prior solid organ transplant.<br><br> - Any serious or uncontrolled medical disorder that, in the opinion of the<br> investigator, may increase the risk associated with study participation or study<br> drug administration, impair the ability of the subject to receive protocol therapy,<br> or interfere with the interpretation of study results.<br><br> - Prior malignancy active within the previous 2 years except for locally curable<br> cancers that have been apparently cured, such as basal or squamous cell skin cancer,<br> superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.<br><br> - Patients with a condition requiring systemic treatment with corticosteroids within<br> 14 days of study drug administration (i.e. prednisone at doses of >10mg). Inhaled or<br> topical steroids and adrenal/pituitary replacement doses >10mg daily prednisone<br> equivalents are permitted.<br><br> - Patients undergoing concurrent treatment with agents targeting tumor necrosis factor<br> alpha (TNF) or IL-1 within 28 days of study enrollment.<br><br> - Patients who have received a live-virus vaccine within 30 days before study drug<br> administration (patients should not be treated with live-virus vaccine while<br> undergoing therapy).<br><br> - History of allergy or hypersensitivity to either darbepoetin alfa or the study drug<br> or its components.<br><br> - Women of child bearing potential who are pregnant or breastfeeding.<br><br> - Subjects who are compulsorily detained for treatment of either a psychiatric or<br> physical (e.g., infectious disease) illness.)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1b: Maximum Tolerated Dose (MTD);Phase 2: Rate of Hematologic Improvement-Erythroid (HI-E) response
- Secondary Outcome Measures
Name Time Method Phase 1b and Phase 2: Duration of Hematologic Improvement-Erythroid (HI-E) response;Phase 1b and Phase 2: Degree in reduction of PRBC Transfusions;Phase 2: Overall Response Rate (ORR);Phase 2: Duration of Response;Phase 2: Overall Survival (OS);Phase 2: Progression Free Survival (PFS)