Phase II Clinical Trial of Alemtuzumab to Treat B-cell Chronic Lymphocytic Leukemia (CLL004)
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|ClinicalTrials.gov Identifier: NCT01982175|
Recruitment Status : Unknown
Verified November 2016 by Shanghai Zhangjiang Biotechnology Limited Company.
Recruitment status was: Recruiting
First Posted : November 13, 2013
Last Update Posted : November 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|B-cell Chronic Lymphocytic Leukemia||Biological: Alemtuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Open, Prospective, Phase II Study of Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection in Patients With Relapse and Refractory B-cell Chronic Lymphocytic Leukemia|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2018|
Patients receive Alemtuzumab escalated from initial dose of 3mg/day then 10mg/day and up to 30mg/day by intravenous infusion(if tolerated). when stable dose of 30mg/day is tolerated, Alemtuzumab is administrated at 30mg by IV infusion 3 times per week for up to 12 weeks (including escalation and stable dose period). After completion of 12 weeks treatment, or discontinuation of treatment within 12 weeks due to disease progression, patients will be visited every 3 months up to 1 year from enrollment or to death, whichever occurs first.
Escalation Phase: Initial Doses of Alemtuzumab 3mg/day by intravenous(IV) infusion until tolerated, then Alemtuzumab 10mg/day IV infusion until tolerated, then Alemtuzumab 30mg IV infusion until tolerated.
Escalation to 30mg/day should be accomplished in 3~7 days.
Stable dose Phase: Once 30mg/day infusion of Alemtuzumab was tolerated, then continue 3 times per week. The total duration of Alemtuzumab therapy including escalation and stable dose phase is 12 weeks.
More than 30mg daily or 90mg weekly dose is prohibited
Other Name: Recombinant Humanized Anti-CD52 Mab
- Objective Response Rate(ORR) [ Time Frame: up to 1 year ]
Objective Response Rate was defined as the proportion of patients who have CR, PR during the study as evaluated according to National Comprehensive Cancer Network(NCCN) guideline 2010 response criteria. Response categories include Complete Response(CR) and Partial Response(PR).
- Progression-Free Survival [ Time Frame: up to 1 year ]Progression-Free Survival was defined as the time from randomization to disease progression (PD) or death due to any cause, whichever comes first.
- Disease Control Rate(DCR) [ Time Frame: up to 1 year ]
Patients were evaluated according to National Comprehensive Cancer Network(NCCN) guideline 2010 response criteria. The best response observed during the study is summarized. Response categories include Complete Response(CR), Partial Response(PR) and Stable Disease(SD).
- Duration of Response(DOR) [ Time Frame: up to 1 year ]Duration of response was analyzed for patients who achieved a complete release(CR) or partial release(PR) and was defined as the time from the first date of documented response to the date of disease progression or death due to any cause.
- Overall Survival [ Time Frame: up to 1 year ]Overall Survival was defined as the duration from randomization to death due to any cause.
- Summary of patients with Adverse Events(AEs) [ Time Frame: up to 1 year ]Analysis of patients with adverse experiences according to CTCAE Version 4.
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): NCT01982175
|Contact: Jing Li, M.D.||email@example.com|
|Contact: Jun Yan, M.D.||86-21-60129299 ext firstname.lastname@example.org|
|Peking University Cancer Hospital||Recruiting|
|Peking, Beijing, China|
|Contact: Jun Zhu, M.D. 86-10-88196596 email@example.com|
|Study Chair:||Jun Zhu, M.D.||Beijing Cancer Hospital|