Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Neoplasm Metastasis

Congenital Abnormalities

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Azacitidine

Decitabine

Midostaurin

Staurosporine

Antimetabolites

Enzyme Inhibitors

Protein Kinase Inhibitors

INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.

POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for up to 1 year.

David J Iberri, MD

This phase 2 study evaluates the sequential combination of decitabine then midostaurin for the treatment of newly-diagnosed acute myeloid leukemia (AML) in older patients.

Treatment with decitabine, a cytidine analog, then midostaurin, a multi-target protein kinase inhibitor (PKI), may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

A Phase 2 Study of Decitabine in Combination With Midostaurin (PKC412) for Elderly Patients With Newly Diagnosed FLT3-ITD/TKD Positive Acute Myeloid Leukemia

The complete remission (CR) rate, or complete response rate, is reported as the sum and proportion of participants that achieved CR or CR with incomplete blood count recovery (CRi), within 12 months of starting midostaurin treatment.

* Complete remission (CR): Bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) \> 1000/μL; platelet count \> 100,000/μL; independence of red cell transfusions.
* CR with incomplete recovery (CRi): All CR criteria except for ANC \< 1000/μL or platelet count \< 100,000/μL.
* Partial remission (PR): All hematologic criteria of CR; except decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.

Overall response rate (ORR) was assessed as the number and proportion of participants who received midostaurin and achieved a partial response (PR), complete response (CR), or complete response with incomplete blood count recovery (CRi).

* Complete remission (CR): Bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) \> 1000/μL; platelet count \> 100,000/μL; independence of red cell transfusions.
* CR with incomplete recovery (CRi): All CR criteria except for ANC \< 1000/μL or platelet count \< 100,000/μL.
* Partial remission (PR): All hematologic criteria of CR; except decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.

Response was assessed by evaluations conducted every 3 cycles (12 weeks). Once documented as partial response (PR), complete response (CR), or complete response with incomplete blood count recover (CRi), response status was confirmed every 12 weeks. In responding participants, duration of response was assessed from the start of treatment through the last documented response before documented progressive disease or death. The outcome is reported as the median value for duration of response, with full range.

* CR: Bone marrow blasts \< 5%; absence of blasts with Auer rods; absence of extramedullary disease; ANC \> 1000/μL; platelet \> 100,000/μL; independence of red cell transfusions.
* CRi: All CR criteria except ANC \< 1000/μL or platelet count \< 100,000/μL.
* PR: All hematologic criteria of CR; except decrease of bone marrow blast percentage to 5% to 25%; \& decrease of pretreatment bone marrow blast percentage by at least 50%.

Progression-free survival (PFS) is reported as the number and proportion of participants who did not receive hematopoietic cell transplantation, and who did not experience disease progression or death for any reason within 2 years after starting midostaurin treatment.

Progressive disease: Bone marrow blasts ≥ 5%; or reappearance of blasts in the blood; or development of extramedullary disease.

Survival is reported as the number and proportion of participants that received midostaurin who remained alive 2 years after starting midostaurin treatment.

David Iberri

Clinical Assistant Professor

INDUCTION THERAPY Subjects receive decitabine intravenously (IV) over 1 hour on days 1 to 10 and midostaurin orally (PO) twice daily (BID) on days 11 to 28. Treatment repeats every 28 days until documented bone marrow response is achieved or for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving documented bone marrow response by course 6 continue treatment with induction therapy; patients achieving response after course 6 proceed to post-remission therapy.

POST-REMISSION THERAPY Subjects receive decitabine IV over 1 hour on days 1 to 5 and midostaurin PO BID on days 6 to 28. Treatment repeats every 28 days for up to 12 courses (including induction therapy) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for up to 1 year.

Decitabine: Given IV

Midostaurin: Given PO

Decitabine, Then Midostaurin

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

David Joseph Iberri, MD; Clinical Assistant Professor (Hematology)

Only participants that started midostaurin therapy are included in the complete response assessment.

Complete Remission (CR) Rate

Only participants that started midostaurin therapy are included in the response assessment.

Overall Response Rate (ORR)

Does not include participants who did not achieve a documented clinical response. Participants who withdrew to receive hematopoietic cell transplant (HCT) are censored at the last assessment of response prior to HCT.

Median Duration of Response (DoR)

Only participants that started midostaurin therapy, and did not withdraw for hematopoietic cell transplantation, are included in the progression-free survival assessment.

Progression-free Survival (PFS)

Only participants that started midostaurin therapy are included in the overall survival assessment.

Spots Global Cancer Trial Database for Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

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