Study Comparing Oral Azacitidine Plus Supportive Care to Supportive Care Alone for Maintenance Therapy in Japanese Patients with Acute Myeloid Leukemia in Complete Remission
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT05197426
This clinical trial is evaluating whether adding the drug oral azacitidine to standard supportive care is more effective and safe compared to supportive care alone for Japanese patients aged 55 and older with Acute Myeloid Leukemia (AML) who are in complete remission after chemotherapy.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The aim of this study is to determine if taking oral azacitidine along with the usual supportive care can help maintain remission in Japanese patients aged 55 and older who have Acute Myeloid Leukemia (AML) and are in complete remission or have incomplete blood count recovery after initial chemotherapy. The study will compare this combination to supportive care alone to see which is more effective and safe.
Eligibility Criteria
Inclusion Criteria
- Aged 55 years or older.
- Newly diagnosed with Acute Myeloid Leukemia (AML) or AML that developed from a previous condition like myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML).
- Must have received initial intensive chemotherapy, with or without additional therapy, and achieved complete remission or remission with incomplete blood count recovery within 4 months before starting the study treatment.
Exclusion Criteria
- Have a type of leukemia called acute promyelocytic leukemia or AML that developed from other blood disorders like chronic myeloid leukemia, except for MDS and CMML.
- Have had a bone marrow or stem cell transplant before.
- Developed AML within four months after stopping treatment with hypomethylating agents for MDS.
- Achieved remission after treatment with hypomethylating agents.
Other specific criteria may apply.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.