Azacitidine and Lenalidomide for Acute Myeloid Leukemia
Summary
Determine toxicity and remission rates of treatment with azacitidine and lenalidomide for patients with Acute Myeloid Leukemia
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.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Leukemia, Myeloid, Acute
Intervention
Azacitidine and Lenalidomide, Azacitidine and Lenalidomide, Azacitidine and Lenalidomide, Azacitidine and Lenalidomide
Location
Washington University School of Medicine
St. Louis
Missouri
United States
63110
Status
Recruiting
Source
Washington University School of Medicine
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01016600
- Information obtained from ClinicalTrials.gov on April 22, 2013
Medical and Biotech [MESH] Definitions
Azacitidine
A pyrimidine analogue that inhibits DNA methyltransferase, impairing DNA methylation. It is also an antimetabolite of cytidine, incorporated primarily into RNA. Azacytidine has been used as an antineoplastic agent.
Clinical Trials
Lenalidomide and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndromes
RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Lenalidomide may also stimulate the immune system in different ways and stop cancer cells...
The hypothesis of this study is that 5-aza and lenalidomide act synergistically in MDS and AML patients with chromosomal abnormalities involving monosomy 5 or del5q. Therefore, this phase...
Epigenetic Modulation in Relapsed/Refractory Follicular Lymphoma and Marginal Zone Lymphoma
The purpose of this study is to evaluate the response and safety in subjects receiving the drugs lenalidomide and azacitidine when each drug is given by itself and when the drugs are taken...
Safety And Efficacy Of Azacitidine, and Lenalidomide In Higher Risk Myelodysplastic Syndrome
To evaluate the overall response rate of the combination of 5-azacitidine + Lenalidomide in high risk MDS patients (INT-2 and High risk defined by IPSS), and patients with low and int-1 wh...
The purpose of this study is to evaluate three things. The first being whether azacitidine is absorbed in the body at the same rate or proportion for different concentrations. The second...
PubMed Articles
Treatment options for older patients with advanced myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) are limited and the prognosis remains poor, thereby warranting development of novel t...
Acute myeloid leukemia (AML) is a disease of the elderly. Poor outcomes with standard therapies necessitate novel approaches. Outpatient regimens sufficiently potent and well tolerated to induce remis...
Continuous lenalidomide treatment for newly diagnosed multiple myeloma.
Lenalidomide has tumoricidal and immunomodulatory activity against multiple myeloma. This double-blind, multicenter, randomized study compared melphalan-prednisone-lenalidomide induction followed by l...
