Protocol

AML08: A Randomized Trial of Clofarabine Plus Cytarabine Versus Conventional Induction Therapy and of Natural Killer Cell Transplantation Versus Conventional Consolidation Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia

Diseases

Leukemias / Lymphomas : acute myeloid leukemia (AML)

Description

Although the treatment outcome for children with leukemia has improved dramatically during the past 20 years, the cure rate for a cute myeloid leukemia (AML) continues to lag behind that achieved for children with acute lymphoblastic leukemia (ALL). Most patients with AML achieve remission after 1 to 2 courses of induction therapy, but approximately half of these patients suffer relapse of their disease. The overall goal of our AML program is to develop novel therapies that overcome drug resistance, decrease relapse rates, and reduce the short- and long-term adverse effects of treatment.

NK cells are a type of toxic white blood cell that constitute a major component of the innate immune system. NK cells play a major role in the rejection of tumors and cells infected by viruses. They kill cells by releasing small granules of proteins called perforin and granzyme that cause the target cell to die. The usage of NK cells provide lot of benefits. The normal role of NK cells is to control infection and prevent cancer. In addition to the anti-leukemia effects, NK cells are capable of reducing the incidence of graft rejection and graft versus host disease (GVHD) in animal models

Numerous responses have been observed after treatment with clofarabine in heavily pre-treated relapsed/refractory patients with ALL or AML. The purpose of this study is to assess the feasibility and effectiveness of a new form of therapy, haploidentical NK cell transplantation, in patients with standard risk AML. This study will also investigate the efficacy of clofarabine + cytarabine in newly diagnosed patients with AML and attempt to optimize outcome through the use of Minimal residual disease (MRD) adapted therapy and further improvements in supportive care.


Objectives


Eligibility

Inclusion Criteria:


Exclusion Criteria:

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE  (1-866-278-5833).


Contact

Jeffrey E. Rubnitz, MD, PhD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN  38105  USA
Voice:   1-866-2ST-JUDE  (1-866-278-5833)
FAX:     901-595-5068

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

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