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Complete title: A Phase 3, Multicenter, Randomized Study to Evaluate the Substitution of Marqibo® (Vincristine Sulfate Liposomes Injection, VSLI) for Standard Vincristine Sulfate Injection (VSI) in the Induction, Intensification, and Maintenance Phases of Combination Chemotherapy in the Treatment of Subjects = 60 Years Old with Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
|Research Study Number||20112071|
|Principal Investigator||Andrei Shustov, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Have provided written, signed, and dated informed consent to participate in the study, in accordance with the 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-) 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, SGOT) or alanine transaminase (ALT, 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.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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.
Other exclusion criteria may apply.
Acute Lymphoid Leukemia (ALL); Hematologic Malignancies
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