CLINICAL TRIAL SUMMARY

MDACC Study No:2009-0100 (clinicaltrials.gov NCT No: NCT00968253)
Title:Phase I/II study of Hyper-CVAD plus RAD001 (everolimus) for patients with relapsed or refractory acute lymphocytic leukemia
Principal Investigator:Marina Konopleva
Treatment Agent:6-mercaptopurine; Citrovorum; Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin; G-CSF; Methotrexate; MESNA; Pegfilgrastim; Prednisone; RAD001; Solumedrol; Vincristine Sulfate
Study Status:Closed
Study Description:The goal of Phase I of this clinical research study is to find the highest
tolerable dose of RAD001 (everolimus) when given in combination with the
standard chemotherapy regimens to patients with ALL.

The goal of Phase II of this study is to learn if the drug combinations can
help to control ALL. The safety of these drug combinations will be also studied
in both phases.

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Disease Group:Leukemia
Phase of Study:Phase I/Phase II
Treatment Agents:6-mercaptopurine
Citrovorum
Cyclophosphamide
Cytarabine
Dexamethasone
Doxorubicin
G-CSF
Methotrexate
MESNA
Pegfilgrastim
Prednisone
RAD001
Solumedrol
Vincristine Sulfate
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:For hyper-CVAD (odd) courses, 4-5 days; for high-dose methotrexate/cytarabine
(even) courses for 3-4 days. Frequency-approximately every 21-28 days, for 8
courses total.
Supported By:Novartis
Return Visit:1-3 times weekly for course 1, then every 1-2 weeks during course 2-8 if
administered at MDACC. If components of the courses 3-8 and maintenance
chemotherapy are delivered by the local oncologist, the participants must come
to MDACC monthly.
Home Care:RAD001 will be self-administered continuously at home. G-CSF can be
administered at home.


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Physician Name:Marina Konopleva
Dept:Leukemia
For Clinical Trial Enrollment:713-794-1628
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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