Phase III Study of Vincristine Sulfate Liposome For Injection In Adults With Naïve Acute Lymphoblastic Leukemia (LY01609)
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|ClinicalTrials.gov Identifier: NCT02072785|
Recruitment Status : Unknown
Verified November 2013 by Nanjing Luye Sike Pharmaceutical Co., Ltd..
Recruitment status was: Recruiting
First Posted : February 27, 2014
Last Update Posted : March 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Adult Acute Lymphoblastic Leukemia||Drug: Vincristine Sulfate Liposome Drug: Vincristine Sulfate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Phase III Study of Vincristine Sulfate Liposome Or Vincristine Sulfate For Injection Combined Chemotherapy as Initial Induction Regimen In Adults Acute Lymphoblastic Leukemia|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||February 2017|
Experimental: Vincristine Sulfate Liposome
Vincristine Sulfate For Injection simulation agent 1.4mg/m2,(2mg, maximum dose), iv, d1, d8, d15, d22. Vincristine Sulfate Liposome For Injection: 1.4mg/m2, (2mg, maximum dose), iv, d1, d8, d15, d22.
Duration between these two agents should be more than 2.5h, and saline should be avoided for flushing before Vincristine Sulfate Liposome For Injection.
Drug: Vincristine Sulfate Liposome
Active Comparator: Vincristine Sulfate
Vincristine Sulfate For Injection 1.4mg/m2,(2mg, maximum dose), iv, d1, d8, d15, d22. Vincristine Sulfate Liposome For Injection simulation agent: 1.4mg/m2,(2mg, maximum dose), iv, d1, 8, 15, 22.
Duration between these two agents should be more than 2.5h, and saline should not be used for flushing before Vincristine Sulfate Liposome For Injection simulation agent.
Drug: Vincristine Sulfate
- Overall response rate(objectives (ORR) [ Time Frame: up to 35 days ]
ORR=CR+CRi CR(Complete response)
- No circulating blasts or extramedullary disease, No lymphadenopathy,splenomegaly,skin/gum infiltration/testicular mass/CNS involvement
- Trilineage hematopoiesis(TLH)and <5% blast in bone marrow
CRi(Complete response with incomplete recovery of counts) Recovery of platelets but<100,000 or ANC is <1000/microl
- Incidence of General peripheral neuropathy [ Time Frame: A week before enrollment. one,two,three and four weeks after the start of induction chemotherapy ]
Chemotherapy-induced peripheral neuropathy was evaluated By Total Neuropathy Score clinical Version(TNSc).
If the score of any item of TNSc at anytime after the start of induction chemotherapy is higher than the baseline,it is considered that peripheral neuropathy occurs.
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): NCT02072785
|Contact: Yingchang Mi, Doctor||86-10-22-23909999|
|Hospital of Blood Diseases, Chinese Academy of Medical Sciences||Recruiting|
|Tianjin, China, 300020|
|Contact: Yingchang MI, Doctor|