Neoplasms

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Leukemia, Myeloid

Leukemia, Myeloid, Acute

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Myeloid Leukemia

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Antineoplastic Agents

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Azacitidine

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Enzyme Inhibitors

5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle

75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle

Bruno Carneiro de Medeiros

Daniel Aaron Pollyea

This study has a phase 1 and a phase 2 component.

In phase 1, the objective is to determine the maximum tolerated dose (MTD) of lenalidomide when after azacitidine.

In phase 2, the objective is to determine the efficacy of the combination treatment.

The treatment regimen in this study is 7 day courses of azacitidine 75 mg/m2 followed by a 21-day courses of lenalidomide. For the primary objective, each 28-day cycle was repeated for a total of up to 6 cycles. Study completion was defined as 18 cycles of treatment, disease progression, or death.

In phase 1, the objective was to determine the maximum tolerated dose (MTD) of lenalidomide 5 mg, 10 mg, 25 mg or 50 mg, when administered after azacitidine.

In phase 2, the objective was to assess the efficacy of MTD lenalidomide administered after azacitidine, in up to six 28-day cycles.

Phase 1-2 of Azacitidine + Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia (AML)

A Phase 1-2 Study of Azacitidine in Combination With Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia

Compete Remission (CR) includes subjects with CR but incomplete recovery of blood counts (CRi). CR was assessed according to the European LeukemiaNet (ELN) guidelines, and is defined as the absence of clonal lymphocytes in the peripheral blood.

"Early death" was assessed as death within 28 days of the start of treatment

The maximum tolerated dose (MTD) of lenalidomide was determined in study phase 1, for use in study Phase 2 (not conducted). The outcome is reported as the dose of lenalidomide that represents the MTD.

Responses and remission were assessed according to the ELN guidelines.

ORR includes subjects with CR, CRi, and partial response (PR). Responses were assessed according to the ELN guidelines.

OS from the start of treatment was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.

CR includes subjects with CR but incomplete recovery of blood counts (CRi). Responses were assessed according to the ELN guidelines.

Responses were assessed according to the ELN guidelines.

OS from the start of treatment of responders (per ELN guidelines) was assessed at a median follow up of 88 weeks from the end of treatment (range, 1-120), and was censored at 1 April 2012.

Celgene Corporation

Stanford University

Assistant Professor

Dose escalation then dose expansion

Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle

Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 1-2 of Azacitidine + Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia (AML)	NCT00890929	Acute Myeloid L... Adult Acute Mye...	Lenalidomide Azacitidine	60 Years -	Stanford University
Phase 1-2 of Azacitidine + Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia (AML)	NCT00890929	Acute Myeloid L... Adult Acute Mye...	Lenalidomide Azacitidine	60 Years -	Stanford University

Spots Global Cancer Trial Database for adult acute myeloblastic leukemia