Phase II study of intensive treatment for newly diagnosed elderly acute myeloid leukemia, fitted for standard chemotherapy like younger adults, by Japan Adult Leukemia Study Group (JALSG-GML219)

JRCT ID: jRCTs041190088

Registered date:27/11/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: acute myeloid leukemia
• Date of first enrollment: 05/12/2019
• Target sample size: 128
• Study type: Interventional
• Intervention(s): After induction induction up to 2 courses (DNR + Ara-C), 3 courses of consolidation therapy ((1) MIT + Ara-C (2) DNR + Ara-C (3) ACR + Ara-C))

Outcome(s)

• Primary Outcome: 2 year event-free survival on all eligible cases

Secondary Outcome

5 year EFS on all eligible cases
2 or 5 year EFS on each subcategory of FAB/WHO classification
2 or 5 year overall survival (OS) on all eligible cases
2 or 5 year OS on each subcategory of FAB/WHO classification
2 or 5 year relapse-free survival (RFS) on all eligible cases for consolidation therapies
2 or 5 year RFS on each subcategory of FAB/WHO classification
Complete remission (CR) rate on all eligible cases and each subcategory of FAB/WHO classification
RFS, OS, EFS and CR rate on each molecular subcategory
Cytogenetic response rate on all eligible rate
Adverse event rate on all eligible category
Treatment performing rate on all eligible cases
Quality of life (QOL) on all eligible cases
Treatment response rate, prognosis and complication rate on each subcategory obtained from comprehensive geriatric assessment or questionnaire on QOL

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: <= 74age old
• Gender: Both

Include criteria

(1) Newly diagnosed as acute myeloid leukemia
(2) Ages, 65-74
(3) ECOG performance status score 0-2
(4) Having sufficient function of liver, kidney, lung and heart
(5) Expected to be alive for more than 3 months at the enrollment
(6) Having ability to concent in written forms following sufficient explanation regarding this study
(7) Asian

Exclude criteria

(1) Having treatment history of myeloproliferative neoplasms, myeloid/lymphoid neoplasms with eosinophilia and gene rearrangement or myelosysplastic/myeloproliferative neoplasms
(2) Therapy-related myeloid neoplasms other than AML
(3) APL with PML-RARA, myeloid sarcoma or myeloid proliferations associated with Down syndrome
(4) Hypoplastic leukemia (less than 20% hypocellularity in bone marrow biopsy along with the absence of fibrotic tissue or other hematological tumors)
(5) Having treatment history for preceding bone marrow failure employing cytotoxic or DNA hypomethylating agents
(6) Having 20-30% bone marrow blasts, not included in "AML with recurrent genetic abnormality" of the WHO classification, included in "myelodyplastic syndromes" in FAB classification, having dysplastic features and preceeding dyshemopoesis, and having no indication for cytotoxic treatment
(7) Having other active cancer
(8) Having history of myocardial infarction within a year
(9) Having uncontrolable diabetes mellitus
(10) Having severe infectious disease
(11) Having liver cirrhosis
(12) Having deep thrombosis to be treated
(13) Having necessity of admission or frequent treatment modification for mental disoreders
(14) Positivity of HBs antigen or HIV antibody

Related Information

• Primary Sponsor: Ito Yoshikazu
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development