A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL
Condition: Acute Lymphoblastic Leukemia (ALL)
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Vincristine Sulfate Liposomes Injection (VSLI); Vincristine Sulfate Injection (VSI)
Intervention description: 2.25 mg/m^2 (without any dose cap) as an IV infusion over 60 minutes.; 1.4 mg/m^2 with a 2 mg dose cap as an IV infusion over 10 minutes.
Intervention MeSH terms: Vincristine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Marqibo; HALLMARQ; leukemia; front-line; ALL; acute lymphoblastic leukemia

Summary:

      A phase 3 study in the treatment of subjects >or= 60 years old with newly diagnosed acute
      lymphoblastic leukemia (ALL).
    

Eligibility criteria:

        Inclusion Criteria:

        Have provided written, signed, and dated informed consent to participate in the study, in
        accordance with the International Council on Harmonisation of Technical Requirements for
        Registration of Pharmaceuticals for Human Use Good Clinical Practice (ICH GCP) Guideline E6
        and all applicable local regulations. Are age >or=60 years (at the time of providing
        informed consent).

        Have newly diagnosed, histologically proven, untreated Philadelphia chromosome-negative
        (Ph-) Acute lymphocytic leukemia [ALL], with >or= 5% bone marrow blasts.

        Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Have a life
        expectancy >or= 3 months.

        Have renal and liver function as defined below within 14 days, inclusive, prior to study
        enrollment, unless the abnormality is considered attributable to leukemia:

        Total bilirubin ≤ 2.0 x the upper limit of normal (ULN), unless the subject has a known
        diagnosis of Gilbert's disease Aspartate transaminase (AST, Serum glutamic oxaloacetic
        transaminase [SGOT]) or alanine transaminase (ALT, Serum glutamic pyruvic transaminase
        [SGPT]) ≤ 3 x ULN Serum creatinine ≤ 1.5 x ULN. Not have had major surgery within 4 weeks
        before the planned start of treatment.

        If female, are post-menopausal, surgically sterilized, or willing to use acceptable methods
        of birth control (eg, hormonal contraceptive, intra-uterine device, diaphragm with
        spermicide, condom with spermicide, or abstinence) from the screening visit through 30 days
        after the last dose of any protocol defined chemotherapeutic agents.

        If male and sexually active with a partner of child-bearing potential, agree to use an
        acceptable barrier method for contraception from the screening visit through 30 days after
        the last dose of any protocol defined chemotherapeutic agents.

        Have the ability and willingness to fully comply with study procedures and restrictions.

        -

        Exclusion Criteria:

        Has had prior systemic chemotherapy (for ALL or other malignancy). Has had prior
        vincristine for any reason. Is planning to undergo stem cell transplantation (SCT) as any
        part of first-line therapy for ALL.

        Has Burkitt's lymphoma/leukemia. Has Philadelphia chromosome-positive (Ph+) ALL and/or
        BCR/ABL rearrangements documented by fluorescent in-situ hybridization (FISH),
        cytogenetics, or polymerase chain reaction (PCR).

        Has active central nervous system (CNS) disease. Has ongoing neuropathy of any etiology >
        Grade 1. Has a history of persistent active neurologic disorders including demyelinating
        form of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, and other
        demyelinating conditions.

        Prior hydroxyurea (Hydrea®) for the management of any condition other than leukocytosis or
        prior hydroxyurea of >7 days duration for the management of leukocytosis (hydroxyurea for
        the management of leukocytosis must be planned to be tapered off before or on Day 5 of
        Induction).

        Has received prior steroids within 7 days before beginning protocol-specified Induction
        therapy for reasons other than leukocytosis (steroids for the management of leukocytosis
        are allowed but must be planned to be tapered off before or on Day 5 of Induction).

        Has an active serious infection not controlled by oral or IV antibiotics or antifungals.

        Has received any investigational therapy within 28 days before beginning any
        protocol-defined chemotherapeutic treatment.

        -