Study Stopped
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A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL
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)
1 other identifier
interventional
26
1 country
15
Brief Summary
A phase 3 study in the treatment of subjects \>or= 60 years old with newly diagnosed acute lymphoblastic leukemia (ALL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2012
Typical duration for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2011
CompletedFirst Posted
Study publicly available on registry
September 23, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedResults Posted
Study results publicly available
September 9, 2021
CompletedSeptember 9, 2021
September 1, 2021
3.7 years
September 20, 2011
November 6, 2019
September 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
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.
36 months
Study Arms (2)
Vincristine Sulfate Injection (VSI)
EXPERIMENTALVSI dosed at 1.4 mg/m\^2 with a 2 mg dose cap as an intravenous (IV) infusion over 10 minutes.
Marqibo
EXPERIMENTALMarqibo dosed at 2.25 mg/m\^2 (without any dose cap) as an IV infusion over 60 minutes.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
UCLA
Los Angeles, California, 90095, United States
Emory University, Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Northwestern University Fienberg School of Medicine
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Washington University School of Medicine
St Louis, Missouri, 63110-1093, United States
Nebraska Medical Center
Omaha, Nebraska, 68198-7680, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Cornell
New York, New York, 10021, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The University of Texas, M.D. Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gajanan Bhat, PhD
- Organization
- Spectrum Pharmaceuticals
Study Officials
- PRINCIPAL INVESTIGATOR
Susan M O'Brien, MD
MD Anderson
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2011
First Posted
September 23, 2011
Study Start
March 1, 2012
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
September 9, 2021
Results First Posted
September 9, 2021
Record last verified: 2021-09