A phase study trial of azacitidine for pre-treated acute myeloid leukemia patients
- Conditions
- Neoplasms
- Registration Number
- KCT0004569
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 23
1) patients aged 19 years or older
(2) Those who have been confirmed as acute myeloid leukemia according to the World Health Organization diagnostic criteria.
(3) Newly diagnosed as acute myeloid leukemia and received at least 1 intensive remission induction chemotherapy or a patients who obtained complete remission previously; however, the patient at least one-line of re-treatment due to relapse of disease
-Intensive remission induction chemotherapy is defined as follows: combination therapy with at least 500 mg / m2 of cytarabine and one or more other drugs combined with anthracycline during the treatment period in order to achieve complete remission.
(4) Failed to obtain complete remission through one or more intensive induction chemotherapy after either new diagnosis or relapse of acute myeloid leukemia
(5) A person deemed unsuitable to receive further intensive chemotherapy at one or more of the following at the time of registration:
? there is a clinically significant accompanying disease
? Eastern Cooperative Oncology Group Performance Score (ECOG PS) = 2
? secondary acute myeloid leukemia
? Accompanied by chromosomal or genetic abnormalities suggesting a poor prognosis [according to 2017 European LeukemiaNet Risk Classification Criteria]
? investigator judges that intensive reinduction chemotherapy cannot be performed
(6) GFR = 30 mL / min, total bilirubin = 3.0 mg / dL, AST and ALT <x5 upper limit of normal (ULN) calculated by Cockcroft-Gault and MDRD method at the time of registration review.
(7) Persons who agree with the high efficiency contraception for the duration of treatment and 3 months after termination
(8) In the case of women of childbearing age, those who agree not to become pregnant or breast-feeding and who have negative pregnancy test on screening tests.
(1) Those who are eligible for intensive chemotherapy at the time of review of enrollment
(2) Patients with mixed phenotype acute leukemia or acute leukemias of ambiguous lineage
(3) patients with acute myeloid leukemia involving the extramedullary central nervous system
(4) Patients with acute myeloid leukemia with t (15; 17) chromosomal translocation or PML / RARa gene abnormality or t (9; 22) chromosomal translocation or BCR-ABL1 gene abnormality
(5) patients with extramedullary myeloid sarcoma that did not involve bone marrow
(6) previously treated with azacitidine or decitabine
(7) Liver cirrhosis patients with Child-Pugh Classification B or higher and those with active hepatitis caused by hepatitis B or hepatitis C.
-Carriers of HBsAg-positive or HBcAb IgG-positive and without evidence of active hepatitis can be enrolled with appropriate antiviral prophylaxis after HBV DNA testing.
Regardless of the hepatitis RNA level, patients positive for hepatitis C antibody can be enrolled if they meet all other criteria and have no evidence of cirrhosis.
-Those who have been diagnosed with HCV less than 6 months before enrollment are considered to have acute HCV and excluded unless a viral load is detected.
(8) Patients with serious infections that require treatment with antibiotics or antifungal agents and are under control and are not suitable for low-intensity treatment with azacitidine (drug-controlled bacterial infection and invasive pulmonary aspergillosis )
(9) Those who have been diagnosed with or are currently on treatment for cancer other than acute myeloid leukemia (breast or prostate cancer or therapeutically resected non-melanoma skin cancer or epithelial cancer that is stable or responsive to endocrine therapy).
(10) Those who underwent major surgery within 21 days (excluding laparotomy for lymph nodes, etc.)
(11) Hypersensitivity to azacitidine and mannitol, another component of this drug
(12) patients with uncontrolled bleeding
(13) pregnant and lactating women
-Women of childbearing potential must have a negative pregnancy test during the screening period.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete remission rate
- Secondary Outcome Measures
Name Time Method Composite overall response;Clinical benefit rate;transition rate to hematopoietic stem cell transplantation or intensive chemotherapy;progression-free survival;overall survival;100 day mortality rate;incidence, characteristics, and severiy of adverse events according to CTCAE V4.03;treatment-related mortality