Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:55 - Any
Updated:11/2/2018
Start Date:April 24, 2013
End Date:April 30, 2019

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A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best-supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission

This study will enroll approximately 460 subjects, aged 55 or older, with a diagnosis of de
novo AML (Acute Myeloid Leukemia) or AML secondary to prior myelodysplastic disease or
chronic myelomonocytic leukemia (CMML), and who have achieved first Complete remission (CR)/
Complete remission with incomplete blood count recovery (CRi) following induction with or
without consolidation chemotherapy. Subjects who have previously achieved CR/CRi with a
hypomethylating agent will be excluded from the study.

This is an international, multicenter, placebo-controlled, phase3 study with a double-blind,
randomized, parallel-group design with de novo AML (Acute Myeloid Leukemia) or AML secondary
to prior diagnosis of Myelodysplasic Syndromes (MDS) or chronic myelomonocytic leukemia
(CMML)

Inclusion Criteria:

1. Male or female subjects ≥ 55 years of age

2. Newly diagnosed, histologically confirmed de novo AML or AML secondary to prior
myelodysplastic disease or CMML (Chronic myelomonocytic leukemia)

3. First Complete remission (CR)/ Complete remission with incomplete blood count recovery
(CRi) with induction therapy + consolidation therapy within 4 months (+/- 7 days of
achieving CR or CRi)

4. Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3

Exclusion Criteria:

1. AML with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) or molecular evidence of
such translocations

2. Prior bone marrow or stem cell transplantation

3. Have achieved CR/CRi following therapy with hypomethylating agents

4. Diagnosis of malignant disease within the previous 12 months

5. Proven Central Nervous System (CNS) leukemia
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601 Elmwood Avenue
Rochester, New York 14642
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330 Brookline Ave
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3551 Roger Brooke Dr
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Gainesville, Florida 32610
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1211 Medical Center Dr
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92 2nd St
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630 W 168th St
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