A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL
- Conditions
- Acute Lymphoblastic Leukemia (ALL)
- Interventions
- Registration Number
- NCT01439347
- Lead Sponsor
- Spectrum Pharmaceuticals, Inc
- Brief Summary
A phase 3 study in the treatment of subjects \>or= 60 years old with newly diagnosed acute lymphoblastic leukemia (ALL).
- Detailed Description
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 \>or= 60 years old with newly diagnosed acute lymphoblastic leukemia (ALL).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vincristine Sulfate Injection (VSI) Vincristine Sulfate Injection (VSI) VSI dosed at 1.4 mg/m\^2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes. Marqibo Vincristine Sulfate Liposomes Injection (VSLI) Marqibo dosed at 2.25 mg/m\^2 (without any dose cap) as an IV infusion over 60 minutes.
- Primary Outcome Measures
Name Time Method Overall Survival 36 months Overall survival was defined as the time from the date of study randomization until death from any cause. Observations censored at the date of the last follow-up for subjects not known to have died.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Emory University, Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Cornell
🇺🇸New York, New York, United States
UCLA
🇺🇸Los Angeles, California, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
The University of Texas, M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Northwestern University Fienberg School of Medicine
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States