Gene Therapy Clinical Trials
Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Cytarabine
- drug: Daunorubicin
- drug: Etoposide
- drug: Clofarabine
- device: CliniMACS
Eligibility
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.
Ages Eligible for Study
N/A - 21 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
6504987061
Not Recruiting