Gary Dahl
Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this study is to compare the effectiveness of two multi-agent chemotherapy regimens using different dosages of cytarabine to eliminate all detectable leukemia.
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Drug: Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone
- Drug: Etoposide, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristine
Phase:
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:
- Diagnosis of acute myeloid leukemia by immunophenotyping, morphology, and cytochemical staining; myelodysplasia; or biphenotypic leukemia.
- Age less than or equal to 21 years at time of study entry.
- No prior therapy for this malignancy (patients with secondary AML following treatment of primary malignancy are eligible) except for one dose of intrathecal therapy.
- Negative pregnancy test
- Patient does not have Down syndrome, acute promyelocytic leukemia (APL), or juvenile myelomonocytic leukemia (JMML)
Key Exclusion Criteria:
- Positive pregnancy test
- Down syndrome, acute promyelocytic leukemia (APL), or juvenile myelomonocytic leukemia (JMML)
Additional Study Details
Official Title:
A Collaborative Trial for the Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or MyelodysplasiaAnticipated start date:
11/5/2002Lead Sponsor:
St. Jude ChildrenCollaborator(s):
- NIH
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
EfficacyPrimary Outcomes:
- Detection of minimal residual disease (MRD) following one course of chemotherapy.
Total Number to be Enrolled:
200Total Number to be Enrolled at Stanford:
65More Information
Secondary ID(s):
- 78496
- AML2002
- NCT00136084
- PEDSAML2002
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:
4/22/2009PLEASE 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.
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