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

• Status: Completed
• Trial end date: 2020-08-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Collaborators: Genzyme, a Sanofi Company; National Cancer Institute (NCI)
• Treatments: Clofarabine; Cytarabine; Daunorubicin; Etoposide; Etoposide phosphate

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.