CLINICAL TRIAL SUMMARY

MDACC Study No:2008-0598 (clinicaltrials.gov NCT No: NCT01319981)
Title:Hyper-CVAD with Liposomal Vincristine (Hyper-CMAD) in Acute Lymphoblastic Leukemia
Principal Investigator:Susan O'Brien
Treatment Agent:6-MP; ARA-C; Cyclophosphamide; Dexamethasone; Doxorubicin; G-CSF; Liposomal Vincristine; Mesna; Methotrexate; Pegfilgrastim; Rituximab
Study Status:Open
Study Description:The goal of this clinical research study is to learn if intensive chemotherapy
(hyper-CVAD therapy) given in combination with liposomal vincristine (Marqibo),
in addition to rituximab for patients who are CD20 positive and/or imatinib or
dasatinib for patients with the Philadelphia (Ph) chromosome, can help to
control ALL or lymphoblastic lymphoma. The safety of this treatment will also
be studied. CD20 is a protein "marker" that is found in leukemia or lymphoma
cells.

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Disease Group:Leukemia
Phase of Study:Phase II
Treatment Agents:6-MP
ARA-C
Cyclophosphamide
Dexamethasone
Doxorubicin
G-CSF
Liposomal Vincristine
Mesna
Methotrexate
Pegfilgrastim
Rituximab
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:4 - 5 days for chemotherapy every 3 weeks.
Supported By:Talon Therapeutics
Return Visit:All protocol specific chemotherapy infusions must be given at MDACC. During
induction, patients (pts) may be hospitalized at MDACC for 1 month. For other
cycles, pts must return to MDACC every 3 - 4 weeks for treatment.
Home Care:Patients may follow with their local oncologist at home for interim followup
visits between courses of chemotherapy, monitoring of blood counts,
transfusions, and administration of antibiotics as indicated.


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Physician Name:Susan O'Brien
Dept:Leukemia
For Clinical Trial Enrollment:713-792-7543
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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