Acute Myeloid Leukemia Clinical Trial
Official title:
an Single Center,Single Arm, Phase 3 Study to Evaluate Efficacy and Safety of PD-1 Inhibitor Combined With Azacytidine and HAG Regimen for Patients With Relapsed or Refractory Acute Myeloid Leukemia.
This is an single center, single arm, phase 3 study to evaluate efficacy and safety of PD-1 Inhibitor combined with DNA methyltransferase inhibitor Azacytidine and HAG regimen for patients with relapsed and refractory acute myeloid leukemia.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | January 1, 2024 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Chinese guidelines for the diagnosis and treatment of relapsed and refractory acute myeloid leukemia (2017 edition),excludes acute promyelocytic leukemia (M3?APL) - Hematopoietic stem cell transplantation =3 months, Discontinue immunosuppressant =3 weeks, Patients without graft-versus-host disease; - Be at least 18 years of age on day of signing informed consent. - Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group(ECOG) Performance Scale - Demonstrate adequate organ function as defined below, all screening labs should be performed before treatment initiation: 1. ALT(SGPT) less than or equal to 2.5 × Upper Limit of Norma(ULN); 2. AST (SGOT) less than or equal to 2.5 × ULN; 3. Serum total bilirubin Less than or equal to 2.0 × ULN Note: If total bilirubin >2.0×ULN, subjects with Gilbert syndrome records are allowed to join the group 4. Serum Creatinine = 30 mL/min 5. Total white blood cell (WBC) count =10,000/µL; Note: hydroxyurea therapy is allowed to reduce white blood cells to meet this inclusion criteria.white blood cells should be determined =24 hours after the last hydroxyurea administration. Final hydroxyurea administration should not =3 days prior to the first azacytidine administration. - Treatment without anthracycline or demethylation. Ability to comprehend the investigational nature of the study and provide informed consent Exclusion Criteria: - Patients with chronic myeloid leukemia,AML of other myeloproliferative disorders Malignant neoplasms with other progression Those who can not control severe infections and other underlying diseases can not tolerate chemotherapy Patients with cardiac insufficiency: ejection fraction (EF)<30%,New York Heart Association(NYHA) standards,Cardiac insufficiency II or above Patients with liver and kidney dysfunction:Serum bilirubin (SB)=2mg/dl,AST is 2.5 times higher than normal upper limit, serum creatinine (SCr) is more than 2.5 mg/dl Serious mental illness uncooperative Refusal to join the study |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Soochow University |
China,
Christman JK. 5-Azacytidine and 5-aza-2'-deoxycytidine as inhibitors of DNA methylation: mechanistic studies and their implications for cancer therapy. Oncogene. 2002 Aug 12;21(35):5483-95. Review. — View Citation
Daver N, Garcia-Manero G, Basu S, Boddu PC, Alfayez M, Cortes JE, Konopleva M, Ravandi-Kashani F, Jabbour E, Kadia T, Nogueras-Gonzalez GM, Ning J, Pemmaraju N, DiNardo CD, Andreeff M, Pierce SA, Gordon T, Kornblau SM, Flores W, Alhamal Z, Bueso-Ramos C, Jorgensen JL, Patel KP, Blando J, Allison JP, Sharma P, Kantarjian H. Efficacy, Safety, and Biomarkers of Response to Azacitidine and Nivolumab in Relapsed/Refractory Acute Myeloid Leukemia: A Nonrandomized, Open-Label, Phase II Study. Cancer Discov. 2019 Mar;9(3):370-383. doi: 10.1158/2159-8290.CD-18-0774. Epub 2018 Nov 8. — View Citation
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Ørskov AD, Treppendahl MB, Skovbo A, Holm MS, Friis LS, Hokland M, Grønbæk K. Hypomethylation and up-regulation of PD-1 in T cells by azacytidine in MDS/AML patients: A rationale for combined targeting of PD-1 and DNA methylation. Oncotarget. 2015 Apr 20;6(11):9612-26. — View Citation
Price SL, Lancet JE, George TJ, Wetzstein GA, List AF, Ho VQ, Fernandez HF, Pinilla-Ibarz J, Kharfan-Dabaja MA, Komrokji RS. Salvage chemotherapy regimens for acute myeloid leukemia: Is one better? Efficacy comparison between CLAG and MEC regimens. Leuk Res. 2011 Mar;35(3):301-4. doi: 10.1016/j.leukres.2010.09.002. Epub 2010 Nov 24. — View Citation
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Tallman MS, Wang ES, Altman JK, Appelbaum FR, Bhatt VR, Bixby D, Coutre SE, De Lima M, Fathi AT, Fiorella M, Foran JM, Hall AC, Jacoby M, Lancet J, LeBlanc TW, Mannis G, Marcucci G, Martin MG, Mims A, O'Donnell MR, Olin R, Peker D, Perl A, Pollyea DA, Pratz K, Prebet T, Ravandi F, Shami PJ, Stone RM, Strickland SA, Wieduwilt M, Gregory KM; OCN, Hammond L, Ogba N. Acute Myeloid Leukemia, Version 3.2019, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019 Jun 1;17(6):721-749. doi: 10.6004/jnccn.2019.0028. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete remission, Incomplete blood count recovery,Partial remission(CR+CRi+PR) | Number of Participants (Responders) Achieving CR+CRi+PR After the Eighth Cycle Treatments | 8 months | |
Secondary | Overall Response Rate (ORR) | Number of Participants (Responders) Achieving Overall Response Rate(ORR) After the Eighth Cycle Treatments | 8 months | |
Secondary | Overall survival (OS) | time from randomization to death from any cause | 3 years | |
Secondary | Event free survival(EFS) | The time between the beginning of the group and the occurrence of any event, including death, progression of the disease, chemotherapy regimen, conversion to chemotherapy, addition of other treatment, occurrence of fatal or intolerable side effects, etc | 3 years | |
Secondary | Progression free survival(PFS) | Time between the beginning of randomization and the progression (in any way) of tumorigenesis or (for any reason) death | 3 years |
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