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Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia

NCT00703820

CompletedPhase 3

Sponsor: St. Jude Children's Research Hospital

Conditions: Acute Myeloid Leukemia

Interventions: Cytarabine, Daunorubicin, Etoposide, Clofarabine, CliniMACS

Countries: United States, Singapore

The purpose of this study is to assess the feasibility and efficacy of a novel form of therapy-haploidentical NK cell transplantation-in patients with standard-risk AML. In addition, we will investigate the efficacy of clofarabine + cytarabine (Clo/AraC) in newly diagnosed patients with AML and attempt to optimize outcome through the use of MRD-adapted therapy and further improvements in supportive care.

Eligibility overview

Sex: ALL

Age: — to 21 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age less than or equal to 21 years at time of study entry.
* No prior therapy for this malignancy except for one dose of intrathecal therapy and the use of hydroxyurea or low-dose cytarabine (100-200 mg/m2 per day for one week or less ) for hyperleukocytosis.
* Written informed consent according to institutional guidelines
* Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
* Male and female participants must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.

Exclusion Criteria:

* Down syndrome
* Acute Promyelocytic Leukemia (APL)
* Juvenile Myelomonocytic Leukemia (JMML)
* Fanconi anemia (FA)
* Kostmann syndrome
* Shwachman syndrome
* Other bone marrow failure syndromes
* Use of concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
* Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of IT therapy, hydroxyurea, or low-dose cytarabine as stated above. The patient must have recovered from all acute toxicities from any previous therapy.
* Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
* Pregnant or lactating patients.
* Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.

Locations (8)

Palo Alto, California, United States
San Diego, California, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Memphis, Tennessee, United States
Fort Worth, Texas, United States
Singapore, Singapore