Status:
COMPLETED
Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Genzyme, a Sanofi Company
National Cancer Institute (NCI)
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE3
Brief 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 investiga...
Detailed Description
The overall objective of this protocol is to improve the cure rate of acute myeloid leukemia (AML). We will compare the immunologic complete response rate after one course of therapy in patients who ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 4 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2020
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT00703820
Start Date
August 4 2008
End Date
August 14 2020
Last Update
August 10 2021
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University Medical Center
Palo Alto, California, United States, 94304
2
Rady Children's Hospital
San Diego, California, United States, 92123
3
University of Chicago
Chicago, Illinois, United States, 60637
4
Dana Farber Cancer Institute and Children's Hospital
Boston, Massachusetts, United States, 02215-5450