Phase II Clinical Trial of Alemtuzumab to Treat B-cell Chronic Lymphocytic Leukemia

Phase 2

Suspended

• Conditions: B-cell Chronic Lymphocytic Leukemia
• Interventions: Biological: Alemtuzumab

• Registration Number: NCT01982175
• Lead Sponsor: Shanghai Zhangjiang Biotechnology Limited Company

Brief Summary

This is a phase II, prospective, multicenter, open-label study to evaluate the efficacy and safety of Alemtuzumab in patients with relapse and refractory B-cell chronic lymphocytic leukemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-05
• Study First Posted: 2013-11-13
• Primary Completion: 2021-02
• Status Verified: 2022-06
• Study Completion: 2022-06
• Last Update Submitted: 2022-06-15
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• An established diagnosis of B-cell chronic lymphocytic leukemia(B-CLL)
• Meet criteria of relapsed or refractory CLL
• Presence of one or more measurable lesions
• ECOG Score 0-1
• Life expectancy > 3 months
• Female patients with childbearing potential must have a negative serum pregnancy test, male and female patients must agree to use an effective contraceptive method while on study treatment, and for a minimum 1 year following study therapy.

Exclusion Criteria

• Less than 2 weeks from prior anti-cancer therapy.
• Allergic to the antibody or any component of the investigational product.
• Other severe, concurrent diseases, including mental disorders, serious cardiac functional capacity (Class III or IV), uncontrolled diabetes.
• Use of investigational agents rather than Alemtuzumab.
• Active systematic infection or major organ malfunction requiring treatment.
• Serum total bilirubin greater than or equal to 1.5 times upper limits of normal; or Serum alanine aminotransferase (ALT) and/or serum aspartate aminotransferase (AST) greater than or equal to 2.5 times upper limits of normal ( no liver metastases); or ALT and/or AST greater than or equal to 5 times upper limits of normal (liver metastases).
• Blood urea nitrogen(BUN) greater than or equal to 1.5 times upper limits of normal or Serum creatinine greater than or equal to 1.5 times upper limits of normal.
• White blood cell(WBC) count< 3.5×109/L or Absolute neutrophil count(ANC)<1.5×109/L or platelet count<75×109/L or Hemoglobin<80g/L.
• Human immunodeficiency virus (HIV) positive.
• Active hepatitis or a history of prior viral hepatitis B or C, or positive hepatitis B serologies without prior immunization.
• Pregnant or nursing women.
• Known central nervous system(CNS) metastases with B-CLL.
• Active secondary malignancy.
• cytomegalovirus(CMV) positive or immunodeficiency disease or after stem cell transplantation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alemtuzumab	Alemtuzumab	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.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate(ORR)	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).; ORR=CR+PR

Secondary Outcome Measures

Name	Time	Method
Duration of Response(DOR)	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	up to 1 year	Overall Survival was defined as the duration from randomization to death due to any cause.
Disease Control Rate(DCR)	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).; DCR=CR+PR+SD
Progression-Free Survival	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.
Summary of patients with Adverse Events(AEs)	up to 1 year	Analysis of patients with adverse experiences according to CTCAE Version 4.

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Peking, Beijing, China