Spots Global Cancer Trial Database for Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia
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Trial Identification
Brief Title: Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia
Official Title: A Phase 2 Study to Evaluate the Safety and Efficacy of Weekly Doses of Marqibo® (Vincristine Sulfate Liposomes Injection) in Adult Patients With Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia (ALL) in Second Relapse or Adult Patients With Philadelphia Chromosome-negative ALL Who Failed Two Treatment Lines of Anti-leukemia Chemotherapy
Study ID: NCT00495079
Conditions
Interventions
Study Description
Brief 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.
Detailed Description: The secondary objectives of this study were to evaluate: * Duration of CR plus CRi * Overall survival * Safety and tolerability
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
USC - Norris Cancer Center, Los Angeles, California, United States
UCLA Medical Center, Los Angeles, California, United States
University of California Medical Center, San Francisco, California, United States
Stanford Hospitals and Clinics, Stanford, California, United States
Rocky Mountain Cancer Center, Denver, Colorado, United States
Emory University - Winship Cancer Institute, Atlanta, Georgia, United States
Loyola University Medical Center, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Univesity of Iowa - Hospitals and Clinica, Iowa City, Iowa, United States
Henry Ford Health System, Detroit, Michigan, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
New York Medical College, Valhalla, New York, United States
Western Pennsylvania Allegheny Health System, Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
Princess Margaret Hospital, Toronto, Ontario, Canada
Dresden University Hospital, Dresden, , Germany
University of Essen, Essen, , Germany
J.W. Goethe University, Frankfurt, , Germany
University of Leipzig, Leipzig, , Germany
University of Muenster, Muenster, , Germany
University of Rostock, Rostock, , Germany
Diakonie-Klinikum Stuttgart, Stuttgart, , Germany
Robert Bosch Hospital, Stuttgart, , Germany
University of Ulm, Ulm, , Germany
Rambam Medical Center, Haifa, , Israel
Hadassah Medical Center - Ein Karem, Jerusalem, , Israel
Rabin Medical Center Campus, Petah-Tikva, , Israel
The Chaim Sheba Medical Center, Tel Hashomer, , Israel
Derriford Hospital, Plymouth, , United Kingdom
Contact Details
Name: Susan O'Brien, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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