Leukemia, Myeloid, Acute Clinical Trial
Official title:
Phase I/II Trial of Azacitidine Plus Lenalidomide in the Treatment of Acute Myeloid Leukemia
Determine toxicity and remission rates of treatment with azacitidine and lenalidomide for patients with Acute Myeloid Leukemia
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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