Hyper-CVAD with Liposomal Vincristine (Hyper-CMAD) in Acute Lymphoblastic Leukemia
If you are reading and signing this form on behalf of a potential participant, please note: Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. 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, dasatinib, or ruxolitinib 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.
Disease Group: Leukemia
Treatment Agent: 6-MP,ARA-C,Cyclophosphamide,Dexamethasone,Doxorubicin,G-CSF,Liposomal Vincristine,Mesna,Methotrexate,Pegfilgrastim,Rituximab,Ruxolitinib
Treatment Location: Only at MDACC
Estimatated Length of Stay in Houston: 4 - 5 days for chemotherapy every 3 weeks.
Sponsor: Spectrum Pharmaceuticals
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.
To determine the CR rate at 1 year of hyper CVAD with liposomal vincristine (Marqibo) in newly diagnosed acute lymphoblastic leukemia (ALL). To determine CR duration, toxicity and overall survival of hyper CVAD with liposomal vincristine (Marqibo) in newly diagnosed ALL.
IRB Review and Approval Date: 03/05/2013
Recruitment Status: Open
Projected Accrual: N/A
1) Newly diagnosed previously untreated ALL or lymphoblastic lymphoma
>/= 18 years old. Allow urgent administration of
cytarabine/hydrea/atra prior to starting treatment on protocol. Allow
previous administration of up to one course of Hyper-CVAD and/or FDA
2) Zubrod performance status </= 3.
3) Adequate liver function (bilirubin </= 3.0 mg/dl unless considered due to tumor) and renal function (creatinine </= 3.0 mg/dl, unless considered due to tumor).
4) No active co-existing malignancy with life expectancy less than 12 months due to that malignancy.
5) All men and women of childbearing potential who are participating in the study must agree to use effective forms of birth control throughout the duration of their treatment.
6) Adequate cardiac function as assessed clinically
1) Pregnant or lactating women. Women of childbearing potential (WOCB)
must have a blood or urine pregnancy test within 7 days prior to
administration of the study drug. (WOCB is defined as a woman who has
not undergone hysterectomy or bilateral oophorectomy and has not been
naturally postmenopausal for at least 24 consecutive months).
2) Active Grade III-IV cardiac failure as defined by the New York Heart Association criteria, uncontrolled angina or MI within 6 months.
3) Patients with medical conditions that compromise their ability to complete the study or confound interpretation of study results.
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