NL-OMON52320已完成3 期
A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination with Azacitidine versus Azacitidine Plus Placebo in Treatment-naïve Patients with Higher Risk Myelodysplastic Syndrome - Gilead 5F9009 ENHANCE (3674/0013)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Participants with MDS defined according to World Health Organization
- •classification, with an IPSS-R prognostic risk category of intermediate, high,
- •or very high risk. Note: participants who require AML-like therapy are not
- •eligible. Prior and concurrent therapy with hydroxyurea, oral etoposide,
- •erythroid, and/or myeloid growth factors is allowed.
- •2. White blood cell (WBC) count <= 20 × 10^3/µL prior to randomization. If the
- •participant*s WBC is > 20 × 10^3/µL prior to randomization, the participant
- •can be randomized, assuming all other eligibility criteria are met. Of note,
- •while this does not impact eligibility, please ensure that the WBC is <= 20 ×
- •10^3/µL prior to the first dose of study treatment and prior to each
- •magrolimab/placebo dose for priming doses of magrolimab.
- •a) Participants can be treated with hydroxyurea (up to 4 g/day) throughout the
- •study or prior to randomization to reduce the WBC to <= 20 × 10^3/µL to enable
- •eligibility and magrolimab dosing. Oral etoposide (up to 200 mg orally per day)
- •may be given as an alternative to hydroxyurea for participants who are
- •intolerant to hydroxyurea or cannot achieve sufficient WBC lowering on
- •hydroxyurea.
- •3. Participant has provided informed consent.
- •4. Participant is willing and able to comply with clinic visits and procedures
- •outlined in the study protocol.
- •5. Male or female, age >= 18 years.
- •6. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
- •7. Willing to undergo blood transfusions as deemed clinically necessary.
- •8. Pretreatment blood cross-match including ABO (any of the 4 blood groups A,
- •B, AB, and O comprising the ABO system)/Rh (Rhesus factor), DAT (direct
- •antiglobulin test), and phenotyping or genotyping completed.
- •9. Biochemical indices within the ranges shown below:
- •a. Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase and
- •alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase <= 3× upper
- •limit of normal (ULN)
- •b. Total bilirubin <= 1.5 × ULN or 3.0 × ULN and primarily unconjugated if
- •participant has a documented history of Gilbert's syndrome or genetic equivalent
- •c. Serum creatinine <= 1.5 × ULN or calculated glomerular filtration rate (GFR)
- •>= 40 mL/min/1.73 m2
- •10. All participants must have a documented hemoglobin >=9.0 g/dL within 24
- •hours prior to the first two doses of magrolimab/placebo infusion. Participants
- •who do not meet these criteria must be transfused and have their hemoglobin
- •rechecked to meet the minimum haemoglobin threshold prior to administering each
- •of the first 2 doses of magrolimab/placebo. Transfusions are allowed in order
- •to meet hemoglobin eligibility.
- •11. Female participants of childbearing potential must not be nursing or
- •planning to be pregnant and must have a negative urine or serum pregnancy test
- •within 30 days before randomization and within 72 hours before the first
- •administration of study treatment.
- •12. Male participants and female participants of childbearing potential who
- •engage in heterosexual intercourse must agree to use protocol-specified methods
- •of contraception as described in protocol Appendix H.
- •13. Willing to consent to mandatory pretreatment and on-treatment bone marrow
- •biopsies (trephines), unless not feasible as determined by the Investigator and
- •discussed with the Sponsor.
排除标准
- •1. Prior treatment with CD47 or SIRPa-targeting agents.
- •2. Prior therapy for the treatment of MDS with an IPSS-R prognostic risk
- •category of intermediate, high or very high risk (excluding hydroxyurea or oral
- •etoposide), prior treatment with hypomethylating agents and/or low dose
- •cytarabine. NOTE: Localized noncentral nervous system (CNS) radiotherapy,
- •erythroid and/or myeloid growth factors, previous hormonal therapy with
- •luteinizing hormone-releasing hormone (LHRH) agonists for prostate cancer, and
- •treatment with bisphosphonates and receptor activator of nuclear factor kappa-B
- •ligand (RANKL) inhibitors are not criteria for exclusion. Prior lenalidomide is
- •also not exclusionary.
- •3.Immediately eligible for an allogeneic SCT, as determined by the
- •Investigator, with an available donor.
- •4. Contraindications to azacitidine, including advanced malignant hepatic
- •tumors or known hypersensitivity to azacitidine or mannitol.
- •5. Known inherited or acquired bleeding disorders.
- •6. Previous SCT within 6 months prior to randomization, active
- •graft-versus-host disease, or requiring transplant-related immunosuppression.
- •7. Clinical suspicion of active CNS involvement by MDS.
- •8. Significant medical diseases or conditions, as assessed by the Investigators
- •and Sponsor, that would substantially increase the risk benefit ratio of
- •participating in the study. This includes, but is not limited to, acute
- •myocardial infarction within the last 6 months, unstable angina, uncontrolled
- •diabetes mellitus, significant active infections, and congestive heart failure
- •New York Heart Association Class III-IV.
- •9. Second malignancy, except treated basal cell or localized squamous skin
- •carcinomas, localized prostate cancer, or other malignancies for which
- •participants are not on active anticancer therapies and have had no evidence of
- •active malignancy for at least >= 1 year.
- •10. History of psychiatric illness or substance abuse likely to interfere with
- •the ability to comply with protocol requirements or give informed consent.
- •11. Pregnancy or active breastfeeding.
- •12. Known active or chronic hepatitis B or C infection or HIV infection in
- •medical history.
- •13. Active hepatitis B virus (HBV) and/or active hepatitis C virus (HCV),
- •and/or HIV following testing at screening:
- •a) Participants who test positive for hepatitis B surface antigen (HBsAg).
- •Participants who test positive for hepatitis B core antibody (anti-HBc) will
- •require HBV DNA by quantitative polymerase chain reaction (PCR) for
- •confirmation of active disease.
- •b) Participants who test positive for HCV antibody. These participants will
- •require HCV RNA by quantitative PCR for confirmation of active disease.
- •c) Participants who test positive for HIV antibody.
- •d) Participants not currently on antiviral therapy and who have an undetectable
- •viral load in the prior 3 months may be eligible for the study.
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