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Clinical Trials/JPRN-jRCTs041190088
JPRN-jRCTs041190088
Active, not recruiting
Phase 2

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) - JALSG-GML219

Ito Yoshikazu0 sites128 target enrollmentNovember 27, 2019
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Ito Yoshikazu
Enrollment
128
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 27, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Ito Yoshikazu

Eligibility Criteria

Inclusion 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

Exclusion 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

Outcomes

Primary Outcomes

Not specified

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