CTRI/2022/09/046033尚未招募3 期
A Randomized, Open-Label Study of the Efficacy and Safety of Galinpepimut-S (GPS) Maintenance Monotherapy Compared to Investigators Choice of Best Available Therapy in Subjects with Acute Myeloid Leukemia Who Have Achieved Complete Remission After Second-Line Salvage Therapy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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
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 ââ?¬Ë?overlapââ?¬• syndrome).
- •4. Subjects must be in second or later morphological complete remission (with or without platelet recovery; CR2/CRp2) for relapsed AML based on the CRp criteria as follows: a. 1000 cells/Ã?µL. e. Peripheral blood platelet count >20,000/Ã?µL f. absence of extramedullary disease.
- •5. Patients must have > 800 lymphocytes/ Ã?µL.
- •6. Patientsââ?¬• leukemic blasts must express WT1 per either IHC or PCR (See APPENDIX 1 and APPENDIX 3)
- •7. Subjects must not be candidates at the time of study entry for allogeneic stem cell transplant (Allo-SCT) due to intercurrent medical conditions, patientââ?¬•s preference or lack of an available donor.
- •8. Subjects must have received the last dose of re-induction antileukemic therapy at least 4 weeks or ten half-lives of induction chemotherapy (whichever is shorter) prior to receiving study treatment.
- •9. Subjects must be consented within 4 months of having achieved CR2/CRp2 or later.
- •10. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, 2 or 3 (See APPENDIX 2: ECOG Performance Status)
- •11. Subjects must have an estimated life expectancy >6 months.
- •12. If female, is postmenopausal (at least 12 sequential months of amenorrhea) or surgically sterile. Females of childbearing potential must have a negative pregnancy test. 13. 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.
- •14. 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 >20,000/Ã?µL).
- •15. Subjects must not have end stage renal disease. 16. Subjects must have adequate hepatic function defined as a serum total bilirubin
排除标准
- •1. For subjects randomized to GPS maintenance monotherapy:
- •a. Continuation of any agents administered as part of induction of CR2/CRp2 or later
- •b. Receiving any concurrent anti-AML systemic therapy
- •c. Prior clinically significant allergic reaction to Montanide, sargramostim (GM-CSF) or filgrastim (granulocyte colony stimulating factor [G-CSF]).
- •d. Received any consolidation and/or maintenance antileukemic therapy, investigational agent, systemic corticosteroid therapy, or other immunosuppressive therapy within 4 weeks prior or 10 half lives, whichever is shorter prior to receiving study treatment. Corticosteroids for chronic conditions (at doses ââ?°Â¤10 mg/day of prednisone or equivalent) are permitted, as are inhalational, intra-ocular, intra articular and topical corticosteroids
- •2. Subjects with an imminently planned hematopoietic stem cell transplant (autologous or allogeneic, with any degree of match donor).
- •3. Subjects with acute promyelocytic leukemia or any morphologic and molecular variants, inclusive.
- •4. Subjects with a serious concurrent illness that in the opinion of the Investigator would pose an undue risk to the subject participating in the clinical study.
- •5. Subjects who currently have, central nervous system leukemia.
- •6. Has 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 (chicken pox), yellow fever, rabies, Bacillus Calmetteââ?¬â??GuÃ?©rin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMistÃ?®) are live attenuated vaccines and are not allowed. Vaccines for Covid-19 used under an EUA, are considered an authorized (though not an approved or cleared) medical product for use in clinical care. Vaccines used for the prevention of Covid-19 are allowed to be used.
- •7. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks, or in the case of drugs 10 half lives, whichever is shorter, prior to the first dose of study treatment.
- •8. Patients who had an SCT after their achieving CR2 or CRp2 or later are not eligible. Patients with prior SCT are allowed only if they had SCT prior to their latest re-induction .
- •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. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor. Steroids taken as short-term therapy (ââ?°Â¤ 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
研究者
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