EUCTR2019-004134-42-FR进行中（未招募）1 期
A Randomized, Open-Label Study of the Efficacy and Safety of Galinpepimut-S (GPS) Maintenance Monotherapy Compared to Investigator's Choice of Best Available Therapy in Subjects with Acute Myeloid Leukemia Who Have Achieved Complete Remission After Second-Line Salvage Therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 116
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients, or their legally acceptable representatives, must be willing and able to understand and provide signed informed consent for the study that fulfills Institution Review Board (IRB) guidelines
- •2. Male or female patients > 18 years of age on the day of signing informed consent
- •3. Subjects must have a diagnosis of AML according to the WHO criteria (primary/de novo or secondary, including treatment-related [e.g., due to prior anthracycline use], as well as cases due to progression of antecedent hematological disorder [e.g., MDS, MPN, or MDS/MPN ‘overlap’ syndrome).
- •4. Subjects must be in second morphological complete remission (with or without platelet recovery; CR2/CRp2) for relapsed AML based on the CRp criteria as follows:
- •a. <5% myeloblasts in bone marrow.
- •b. Absence of Auer rods
- •c. Absence of circulating peripheral blasts.
- •d. Peripheral blood absolute neutrophil count (ANC) >1000 cells/µL.
- •e. Peripheral blood platelet count >60,000/µL
- •f. Absence of extramedullary disease.
- •5. Patients must have > 800 lymphocytes/ µL.
- •6. Patients’ leukemic blasts must express WT1 per IRS scoring system (See APPENDIX 1: WT1 IHC Assessment and Documentation)
- •7. Subjects must be free of any requirement for red blood cell transfusions.
- •8. Subjects must not be candidates at the time of study entry for allogeneic stem cell transplant (Allo-SCT) due to intercurrent medical conditions or lack of an available donor.
- •9. Subjects must have received the last dose of induction antileukemic therapy at least 3 months prior to study enrolment.
- •10. Subjects must be consented within 4 months of having achieved CR2/CRp2
- •11. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 (See APPENDIX 2: ECOG Performance Status)
- •12. Subjects must have an estimated life expectancy >6 months.
- •13. If female, is postmenopausal (at least 12 sequential months of amenorrhea) or surgically sterile. Females of childbearing potential must have a negative pregnancy test
- •14. Female patients of childbearing potential who are heterosexually active and male patients with female sexual partners of childbearing potential must agree to use an effective method of contraception (e.g., oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device) during the study and for 4 months following the last dose of study medication, or to abstain from sexual intercourse for this time; a woman not of childbearing potential is one who has undergone bilateral oophorectomies or who is post- menopausal, defined as the absence of menstrual periods for 12 consecutive months.
- •15. Subjects must have recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5 Grade 0 or 1 after completion of prior AML therapy with the exception of the platelet count requirements (i.e., as long as peripheral blood platelet count is >60,000/µL).
- •16. Subjects must have adequate renal function defined as a serum creatinine <2 × upper limit of normal (ULN) or calculated creatinine clearance > 30 mL/min based on the Cockroft-Gault equation.
- •17. Subjects must have adequate hepatic function defined as a serum total bilirubin <2 × ULN (except for Gilbert’s syndrome, which will allow bilirubin =3.0 mg/dL), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3 × ULN.
- •18. Subjects must be willing and able to return to the clinical site for adequate follow-up and to comply with the protocol as required
排除标准
- •1. For subjects randomized to GPS maintenance monotherapy:
- •Continuation of any agents administered as part of induction of CR2/CRp2
- •Receive any concurrent anti-AML systemic therapy
- •Prior clinically significant allergic reaction to Montanide, sargramostim or filgrastim (granulocyte colony stimulating factor).
- •Receive any consolidation and/or maintenance antileukemic therapy, investigational agent, systemic corticosteroid therapy, or other immunosuppressive therapy within 4 weeks prior to enrolment within the study. Corticosteroids for chronic conditions (at doses =7.5 mg/day of prednisone or equivalent) or permitted, as are inhalational, intra-ocular, intra-articular and topical corticosteroids.
- •2. Subj. with an imminently planned hematopoietic stem cell transplant (autologous or allogeneic, with any degree of match donor).
- •3. Subj. with acute promyelocytic leukemia or any morphologic and molecular variants, inclusive.
- •4. Subj. with a serious concurrent illness that in the opinion of the Investigator would pose an undue risk to the subject being participating in the clinical study.
- •5. Subj. with a history of, or who currently have, central nervous system leukemia.
- •6. Received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette–Guérin , and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
- •7. Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- •8. Subj. who had an SCT after their achieving CR2 or CRp2 are not eleigible. Subj. with prior SCT are allowed only if they had SCT after CR1 (but not CR2 or CRp2).
- •9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor. Steroids taken as short-term therapy (= 7 days) for antiemesis are permissible.
- •10. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years, even if currently inactive or unapparent.
- •11. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- •12. Has known hypersensitivity to Montanide or vaccine adjuvants.
- •13. Had a previous clinically significant systemic allergic reaction to Montanide, sargramostim (GM-CSF), or filgrastim (G-CSF).
- •14. Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid r
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