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Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia
NCT00495079 · View on ClinicalTrials.gov ↗
Study Summary
This was a Phase 2, international, multicenter, open-label, single-arm trial evaluating Marqibo (VSLI) in adult subjects with: 1) Ph- ALL or lymphoblastic lymphoma in second or greater relapse; or 2) Ph- ALL or lymphoblastic lymphoma who failed 2 or greater treatment lines of anti-leukemia chemotherapy. The original enrollment target for this study was approximately 56 subjects. Per a protocol amendment, enrollment was increased from 56 to 65. The primary objective of this study was to evaluate: \- The efficacy of the study treatment as determined by the rate of CR plus CR with incomplete blood count recovery (CRi) in adult subjects with Philadelphia chromosome-negative (Ph-) ALL in second relapse or adult subjects with (Ph-) ALL who failed 2 treatment lines of anti-leukemia chemotherapy. Subjects must have achieved a CR to at least 1 prior anti-leukemia therapy as defined by a leukemia-free interval of ≥ 90 days.
Conditions Studied
Interventions
- DRUG Marqibo® (vincristine sulfate liposomes injection)
Study Locations (20)
California
- USC - Norris Cancer Center — Los Angeles
- UCLA Medical Center — Los Angeles
- University of California Medical Center — San Francisco
- Stanford Hospitals and Clinics — Stanford
Illinois
- Loyola University Medical Center — Chicago
- Rush University Medical Center — Chicago
- University of Chicago Medical Center — Chicago
New York
- Roswell Park Cancer Institute — Buffalo
- New York Medical College — Valhalla
Pennsylvania
- Western Pennsylvania Allegheny Health System — Pittsburgh
- University of Pittsburgh Medical Center — Pittsburgh
Colorado
- Rocky Mountain Cancer Center — Denver
Georgia
- Emory University - Winship Cancer Institute — Atlanta
Iowa
- Univesity of Iowa - Hospitals and Clinica — Iowa City
Michigan
- Henry Ford Health System — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2007-05 |
| Est. Completion | 2010-08-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00495079
The ClinicalTrials.gov registry entry for NCT00495079 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spectrum Pharmaceuticals, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Acute Lymphoblastic Leukemia (ALL) appearing as the primary indexed condition, and to 1 intervention — of which Marqibo® (vincristine sulfate liposomes injection) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00495079 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Illinois, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00495079 about?
NCT00495079 is a clinical study titled "Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia". This was a Phase 2, international, multicenter, open-label, single-arm trial evaluating Marqibo (VSLI) in adult subjects with: 1) Ph- ALL or lymphoblastic lymphoma in second or greater relapse; or 2) Ph- ALL or lymphoblastic lymphoma who failed 2 or greater treatment lines of anti-leukemia chemother...
What is the current status of trial NCT00495079?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2007-05. Estimated completion is 2010-08-08.
What conditions does trial NCT00495079 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia (ALL). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00495079?
The interventions under investigation include: Marqibo® (vincristine sulfate liposomes injection) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00495079?
This trial is sponsored by Spectrum Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00495079 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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