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Full eligibility criteria for NCT01439347
Ages eligible for Study
60 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01439347
United States (15)
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Los Angeles, California, United States, 90095
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Northwestern University Fienberg School of Medicine
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Washington University School of Medicine
St. Louis, Missouri, United States, 63110-1093
Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
New York, New York, United States, 10021
Duke University Medical Center
Durham, North Carolina, United States, 27710
Cleveland, Ohio, United States, 44195
The University of Texas, M.D. Anderson Cancer Center
Houston, Texas, Texas, United States, 77030-4009
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
View full eligibility
Tris trial is registered with FDA with number: NCT01439347. The sponsor of the trial is Spectrum Pharmaceuticals, Inc and it is looking for 26 volunteers for the current phase.
Official trial title: Phase 3 Study of Study to Evaluate Marqibo® in the Combination Chemotherapy in the Treatment of Subjects >or=60 Years Old With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
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