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 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.
|Acute Lymphoblastic Leukemia (ALL)||Drug: Marqibo® (vincristine sulfate liposomes injection)||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- 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
|Study Start Date:||May 2007|
|Study Completion Date:||March 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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
The secondary objectives of this study were to evaluate:
- Duration of CR plus CRi
- Overall survival
- Safety and tolerability
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495079
Show 33 Study Locations
|Principal Investigator:||Susan O'Brien, MD||M.D. Anderson Cancer Center|