Liposomal vincristine for patients with newly diagnosed acute lymphoblastic leukemia

This study aimed to investigate the outcomes for patients with newly diagnosed acute lymphoblastic leukemia who were treated liposomal vincristine and chemotherapy. 

This study concluded that this combination was safe and effective in these patients.  

Liposomal vincristine (Marqibo) is a chemotherapy drug that has been approved as a salvage therapy in relapsed/unresponsive acute lymphoblastic leukemia (ALL). Salvage therapy is given if a patient does not respond to standard therapy. Hyper-CVAD (cyclophosphamide, vincristine sulfate, doxorubicin, and dexamethasone) is an intensive chemotherapy regime used to treat ALL patients. Methotrexate and cytarabine are also given in this regimen. When vincristine sulfate is replaced by liposomal vincristine, this is called hyper-CMAD. 

It was not known if liposomal vincristine and hyper-CMAD were a safe and effective combination for treating patients with newly diagnosed ALL.  

This study involved 31 patients with newly diagnosed B-cell ALL. Patients received liposomal vincristine (rather than regular vincristine) in combination with Hyper-CMAD. Patients were followed for an average of 59 months. 42% of patients had CD20 positive ALL and 68% had Ph-positive CLL. CD20 positive patients received rituximab and Ph-positive patients received imatinib or dasatinib.  

97% of patients involved achieved complete remission (CR – all signs of cancer gone). All patients with abnormal chromosomes (genetic material) achieved complete cytogenetic response (CCyR). CCyR is when there are no cells with a Ph chromosome found (this is found in cancer cells). 90% of these patients achieved negative minimal residual disease (MRD). MRD is the small number of cancer cells left after treatment.  

95% of Ph-positive ALL patients achieved a major molecular response (MMR). MMR is when there is a low amount of BCR-ABL gene present. BCR-ABL is found in cancer cells. 70% of these patients achieved complete molecular response (CMR). CMR is when there is no BCR-ABL gene found.  

Peripheral neuropathy (nerve damage) was a side effect found in 68% of patients. 

After an average follow-up of 59 months, 68% of patients were alive. The 5-year complete response (CR) duration rate was 73%. The 5-year survival rate was 61%.  

This study concluded that hyper-CMAD with liposomal vincristine was safe and effective in patients with newly diagnosed ALL.  

This study had a small number of participants. This study was funded by Spectrum Pharmaceuticals Inc. & Acrotech Biopharma, the manufacturer of liposomal vincristine.