Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Rituximab; Imatinib; Cyclophosphamide; Doxorubicin; Mesna; VSLI; Solu-Medrol; Methotrexate; Ara-C; G-CSF; Pegfilgrastim; Dexamethasone
Intervention description: In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4.; 600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).; 300 mg/m2 by vein over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for courses 1, 3, 5, 7; 50 mg/m2 by vein over 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7; 600 mg/m2 by vein continuous infusion daily for 24 hours days 1-3 for courses 1, 3, 5, 7; 2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7; 40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8.; 200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 beginning after the completion of rituximab for Courses 2, 4, 6, and 8.; 3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Courses 2, 4, 6, and 8.; 10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10^9/L by day 21.; 6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.; 40 mg by vein or by mouth daily days 1-4 and days 11-14 for courses 1, 3, 5, 7
Intervention MeSH terms: Cytarabine; Dexamethasone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Cyclophosphamide; Rituximab; Doxorubicin; Methotrexate; Vincristine; Imatinib Mesylate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Lymphoblastic Leukemia; ALL; Lymphoblastic lymphoma; Cytoxan; Neosar; Mesnex; Liposomal Vincristine; Vincristine Sulfate Liposomes Injection; Marqibo; Dexamethasone; Adriamycin; Rubex; Cytarabine; Cytosar; DepoCyt; Cytosine Arabinosine Hydrochloride; Imatinib Mesylate; Gleevec; ST1571; NSC-716051; Filgrastim; Neupogen

Summary:

      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.

      This is an investigational study. Liposomal vincristine is FDA approved for the treatment of
      patients with CLL who have relapsed at least 2 times. All of the other study drugs used in
      this study are FDA approved and commercially available. The combination of liposomal
      vincristine with the other study drugs is also being used in research only.

      Up to 65 patients will take part in this study. All will be enrolled at MD Anderson.
    

Eligibility criteria:

        Inclusion Criteria:

          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
             approved TKI.

          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

        Exclusion Criteria:

          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.