Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00495079 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia
A Phase 2 study of Acute Lymphoblastic Leukemia (ALL), sponsored by Spectrum Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 20
- Study locations
NCT00495079 is a Phase 2 study of Acute Lymphoblastic Leukemia (ALL) that has completed, run by Spectrum Pharmaceuticals. The registered enrollment target is 65 participants, below the 6,302-participant average among 16 other Acute Lymphoblastic Leukemia (ALL) trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT00495079, a Phase 2 study of Acute Lymphoblastic Leukemia (ALL), has completed, sponsored by Spectrum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,302-participant average among 16 other Acute Lymphoblastic Leukemia (ALL) trials with a reported enrollment target (99% lower). The listed sponsor is Spectrum Pharmaceuticals, which has 52 total studies on file at ClinicalTrials.gov.
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.
NCT00495079 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Illinois, New York.
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).
What interventions are being tested in trial NCT00495079?
The interventions under investigation include: Marqibo® (vincristine sulfate liposomes injection) (DRUG).
Who is sponsoring clinical trial NCT00495079?
This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Acute Lymphoblastic Leukemia (ALL)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Cord Blood Transplant in Adults With Blood Cancers
RECRUITING · Phase 2
-
TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies
ACTIVE NOT RECRUITING · Phase 2
-
Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation
ACTIVE NOT RECRUITING · Phase 2
-
Bright Ideas - CIN Feasibility Study
RECRUITING · NA
-
Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia
RECRUITING · NA
-
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
RECRUITING
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.