Gary Dahl
Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Cytarabine
- Drug: Daunorubicin
- Drug: Etoposide
- Drug: Clofarabine
Phase:
Phase 2/Phase 3Eligibility
Ages Eligible for Study:
Any Age to 21 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Inclusion Criteria:
- Age 21 years at time of study entry.
- No prior therapy for this malignancy except for one dose of intrathecal therapy and use of hydroxyurea
- 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 and hydroxyurea, 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.
Key Exclusion Criteria:
Additional Study Details
Official Title:
AML08: A Phase II Randomized Trial of Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Phase II Study Of Natural Killer Cell Transplantation In Patients With Newly Diagnosed Acute Myeloid LeukemiaAnticipated start date:
5/27/2009Lead Sponsor:
St. Jude ChildrenCollaborator(s):
- Genzyme
- NIH
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Single BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- To compare the immunologic complete response rate after one course of therapy in patients who receive cytarabine + daunorubicin + etoposide (ADE) with that in patients who receive clofarabine + cytarabine (Clo/AraC) [ Time Frame: Day 22 MRD measurement ]
Total Number to be Enrolled:
270Total Number to be Enrolled at Stanford:
10More Information
Secondary ID(s):
- AML08
- NCT00703820
- PEDSAML08
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/18/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
Help
Trial Administration