Conditions: Leukemia, Myeloid, Acute
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 31
Healthy volunteers: no

Brief summary:
Determine toxicity and remission rates of treatment with azacitidine and lenalidomide for patients with Acute Myeloid Leukemia

Detailed description:
Primary:

Phase 1:

To determine the toxicity and feasibility of combining lenalidomide and azacitidine in patients with relapsed/ refractory AML ≥ 18 years or untreated AML ≥60 years.

Phase 2:

To assess the complete remission (CRm plus CRi) rate after lenalidomide + azacitidine therapy in untreated AML ≥60 years.

Secondary:

1. To assess the response rate (RR), morphologic leukemia-free state, morphologic complete remission rate (CRm), cytogenetic CR (CRc) rate, CR with incomplete blood counts 14 rate, and partial remission 15 rate (PR).
2. To assess overall survival (OS) and event free survival (EFS).
3. To assess time to progression (TTP) in untreated AML ≥60 years.
4. To assess relapse free survival (RFS) and duration of CR for complete responders.
5. To determine the incidence and severity of other toxicities of lenalidomide in combination with azacitidine.
6. Assay the expression levels of cytokines/chemokines in the bone marrow plasma, expression of chemokine receptors/ligands on leukemic blasts important for the AML microenvironment and study the direct cytotoxic effects of lenalidomide, azacitidine and combination of both drugs on cryopreserved AML blast cells.

Arms:
arm 1: Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 25 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5 arm 2: Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 50 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5 arm 3: Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5 arm 4: Induction regimen (total 2 cycles)

Lenalidomide 50 mg PO daily days 1-28

Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5

Maintenance Regimen

Lenalidomide 10 mg PO daily days 1-28

Azacitidine 75 mg/m2 IV days 1-5

Interventions: intervention 1: Lenalidomide intervention 2: Azacitidine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: