Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia
|ClinicalTrials.gov Identifier: NCT00495079|
Recruitment Status : Completed
First Posted : July 2, 2007
Results First Posted : November 29, 2012
Last Update Posted : December 27, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia (ALL)||Drug: Marqibo® (vincristine sulfate liposomes injection)||Phase 2|
The secondary objectives of this study were to evaluate:
- Duration of CR plus CRi
- Overall survival
- Safety and tolerability
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2007|
|Primary Completion Date :||January 2011|
|Study Completion Date :||March 2011|
U.S. FDA Resources
Eligible subjects received study drug at 2.25 mg/m^2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
Drug: Marqibo® (vincristine sulfate liposomes injection)
Dosing was done every 7 days (± 3 days) on Days 1, 8, 15, and 22 with no less than 4 days between dosing days. Dose calculations were based on body surface area using the subject's height (from Screening) and actual weight for each course.
Other Name: VSLI, Vincristine Sulfate Liposomes Injection
- Complete Remission Plus Complete Remission Without Full Platelet Recovery (CR + CRi) [ Time Frame: Response assessment performed at the end of each 28 day course. ]CR is defined as no evidence of ALL: ANC>or=1x10^9/L or platelet count>100x10^9/L, absence of leukemia blast cells in blood and marrow (<5% blasts), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery (CRi): As per CR but platelet count< 100x10^9/L or ANC< 1x10^9/L. Partial remission(PR):CR with>5-25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. Reduction in EMD by at least 50%. Hematologic Improvement. Bone marrow blast(BMB) response: BMB<5% in the absence of HI. Stable disease(SD):No significant hematological and extramedullary change from baseline.
- Clinical Response Assessment Per Independent Response Review Committee (IRRC) Evaluation [ Time Frame: Response assessment at the end of each 28 days course ]Number of subjects who achieved Complete Remission (CR)as assessed by the IRRC. CR is defined as no evidence of ALL. ANC>=1X10^9/L or Platelet count>=100x10^9/L, absence of blasts in blood and morrow (<5%), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery(CRi)is defined as per CR but platelet count <100x10^9/L or ANC<1x10^9/L.
- Duration of CR + CRi [ Time Frame: CR + CRi duration was calculated from the date the subject first met the definition of CR or CRi until the date of relapse ]Duration of response for those subjects who achieved CR or CRi
- Overall Survival [ Time Frame: unlimited ]Time, in days, from informed consent date until the date of death or date of last contact
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495079
Show 33 Study Locations
|Principal Investigator:||Susan O'Brien, MD||M.D. Anderson Cancer Center|